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Brain Stimulation for Neurological Patients

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ClinicalTrials.gov Identifier: NCT03770182
Recruitment Status : Recruiting
First Posted : December 10, 2018
Last Update Posted : October 13, 2021
Sponsor:
Collaborator:
Medical University of Vienna
Information provided by (Responsible Party):
Storz Medical AG

Tracking Information
First Submitted Date  ICMJE September 7, 2018
First Posted Date  ICMJE December 10, 2018
Last Update Posted Date October 13, 2021
Actual Study Start Date  ICMJE January 24, 2017
Estimated Primary Completion Date September 30, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 11, 2018)
Consortium to Establish a Registry for Alzheimer's Disease (CERAD) - Corrected Total Score [ Time Frame: month 3 ]
CERAD stands for "The Consortium to Establish a Registry for Alzheimer's Disease". The CERAD was funded by the National Institute on Aging in 1986 to develop standardized, validated measures for the assessment of Alzheimer's disease (Fillenbaum 2008). CERAD is a cognitive test battery which is normalized for age, gender and education (Morris 1988). The CERAD total score (Chandler 2005) is a good measure for Alzheimer's Disease (Ehrensperger 2010, Rossetti 2010, Seo 2010, Hallikainen 2013). The CERAD total score is a scale from 0 to 100 with 100 meaning "normal cognitive ability" and 0 meaning "severe cognitive impairment".
Original Primary Outcome Measures  ICMJE
 (submitted: December 6, 2018)
Consortium to Establish a Registry for Alzheimer's Disease (CERAD) - Corrected Total Score [ Time Frame: month 3 ]
The Consortium to Establish a Registry for Alzheimer's Disease (CERAD) was funded by the National Institute on Aging in 1986 to develop standardized, validated measures for the assessment of Alzheimer's disease (Fillenbaum 2008). CERAD is a cognitive test battery which is normalized for age, gender and education (Morris 1988). The CERAD total score (Chandler 2005) is a good measure for Alzheimer's Disease (Ehrensperger 2010, Rossetti 2010, Seo 2010, Hallikainen 2013).
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 31, 2020)
  • Alzheimer's Disease Assessment Scale (ADAS) [ Time Frame: immediately post-treatment ]
    Cognitive test. The Alzheimer's Disease Assessment Scale (ADAS) was designed to evaluate the severity of cognitive and noncognitive behavioral dysfunctions characteristic of persons with Alzheimer's disease (Rosen 1984). It consists of 21 items. Its sensitivity seems limited in mild AD (Irizarry 2008) but it is commonly used with AD intervention studies. The ADAS total score (ADASUM) ranges from 0 to 120 and consists of two subscales, the ADAS-COG with 70 possible points and the ADAS-NonCog with 50 possible points. In both subscales and total scale 0 points means "healthy" and the highest score means "severe impairment". The total score ADASUM is the sum of both subscales. Its cognition subscale (ADAS-COG) is a standard tool in pivotal clinical trials to detect therapeutic efficacy in cognition (Robert 2010). The ADAS-COG includes 11 items assessing the several cognitive domains.
  • Alzheimer's Disease Assessment Scale (ADAS) [ Time Frame: month 1 ]
    Cognitive test. The Alzheimer's Disease Assessment Scale (ADAS) was designed to evaluate the severity of cognitive and noncognitive behavioral dysfunctions characteristic of persons with Alzheimer's disease (Rosen 1984). It consists of 21 items. Its sensitivity seems limited in mild AD (Irizarry 2008) but it is commonly used with AD intervention studies. The ADAS total score (ADASUM) ranges from 0 to 120 and consists of two subscales, the ADAS-COG with 70 possible points and the ADAS-NonCog with 50 possible points. In both subscales and total scale 0 points means "healthy" and the highest score means "severe impairment". The total score ADASUM is the sum of both subscales. Its cognition subscale (ADAS-COG) is a standard tool in pivotal clinical trials to detect therapeutic efficacy in cognition (Robert 2010). The ADAS-COG includes 11 items assessing the several cognitive domains.
  • Alzheimer's Disease Assessment Scale (ADAS) [ Time Frame: month 3 ]
    Cognitive test. The Alzheimer's Disease Assessment Scale (ADAS) was designed to evaluate the severity of cognitive and noncognitive behavioral dysfunctions characteristic of persons with Alzheimer's disease (Rosen 1984). It consists of 21 items. Its sensitivity seems limited in mild AD (Irizarry 2008) but it is commonly used with AD intervention studies. The ADAS total score (ADASUM) ranges from 0 to 120 and consists of two subscales, the ADAS-COG with 70 possible points and the ADAS-NonCog with 50 possible points. In both subscales and total scale 0 points means "healthy" and the highest score means "severe impairment". The total score ADASUM is the sum of both subscales. Its cognition subscale (ADAS-COG) is a standard tool in pivotal clinical trials to detect therapeutic efficacy in cognition (Robert 2010). The ADAS-COG includes 11 items assessing the several cognitive domains.
  • Neuropsychological Test Battery Vienna (NTBV) [ Time Frame: immediately post-treatment ]
    The Neuropsychological Test Battery Vienna (NTBV) ist a cognitive test, which was created to detect Alzheimer's Disease (Lehrner 2007).
  • Neuropsychological Test Battery Vienna (NTBV) [ Time Frame: month 1 ]
    Cognitive test
  • Neuropsychological Test Battery Vienna (NTBV) [ Time Frame: month 3 ]
    Cognitive test
  • CERAD [ Time Frame: immediately post-treatment ]
    Cognitive test
  • CERAD [ Time Frame: month 1 ]
    Cognitive test
  • CERAD [ Time Frame: month 3 ]
    Cognitive test
  • Clock drawing test [ Time Frame: immediately post-treatment ]
    The clock drawing test shows the visuoconstructive skills (Shulman 1986). The subject is asked to draw the face of a clock with all numbers and to set the hands for a specified time (hh:mm). Scores range from 0 (worst) to 7 (best).
  • Clock drawing test [ Time Frame: month 1 ]
    Clock drawing test
  • Clock drawing test [ Time Frame: month 3 ]
    Clock drawing test
  • Forgetfulness assessment inventory (FAI) [ Time Frame: immediately post-treatment ]
    FAI stands for "Forgetfulness Assessment Inventory". The Forgetfulness Assessment Inventory is a questionnaire. Kogler et al (2013) developed the forgetfulness assessment inventory FAI (German: Skala zur Erfassung der Gedächtnisleistung - SEG) to evaluate subjective complaints regarding everyday memory problems. Lehrner et al. (2014) validated the test. The FAI consists of 16 items to measure subjective memory problems in daily life based on a Likert scale. The FAI focuses on the subjective evaluation of memory problems, particularly in relation to episodic memory, which has been found to be very sensitive in the early detection of mild cognitive impairment and AD (Lehrner 2014). This questionnaire is supposed to be completed by the patient as well as by a person familiar with the patient. The total score ranges from 0 to 80. Higher scores reflect poorer subjective functioning and greater complaints.
  • Forgetfulness assessment inventory (FAI) [ Time Frame: month 1 ]
    FAI stands for "Forgetfulness Assessment Inventory". The Forgetfulness Assessment Inventory is a questionnaire. Kogler et al (2013) developed the forgetfulness assessment inventory FAI (German: Skala zur Erfassung der Gedächtnisleistung - SEG) to evaluate subjective complaints regarding everyday memory problems. Lehrner et al. (2014) validated the test. The FAI consists of 16 items to measure subjective memory problems in daily life based on a Likert scale. The FAI focuses on the subjective evaluation of memory problems, particularly in relation to episodic memory, which has been found to be very sensitive in the early detection of mild cognitive impairment and AD (Lehrner 2014). This questionnaire is supposed to be completed by the patient as well as by a person familiar with the patient. The total score ranges from 0 to 80. Higher scores reflect poorer subjective functioning and greater complaints.
  • Forgetfulness assessment inventory (FAI) [ Time Frame: month 3 ]
    FAI stands for "Forgetfulness Assessment Inventory". The Forgetfulness Assessment Inventory is a questionnaire. Kogler et al (2013) developed the forgetfulness assessment inventory FAI (German: Skala zur Erfassung der Gedächtnisleistung - SEG) to evaluate subjective complaints regarding everyday memory problems. Lehrner et al. (2014) validated the test. The FAI consists of 16 items to measure subjective memory problems in daily life based on a Likert scale. The FAI focuses on the subjective evaluation of memory problems, particularly in relation to episodic memory, which has been found to be very sensitive in the early detection of mild cognitive impairment and AD (Lehrner 2014). This questionnaire is supposed to be completed by the patient as well as by a person familiar with the patient. The total score ranges from 0 to 80. Higher scores reflect poorer subjective functioning and greater complaints.
  • Instrumental Activities of Daily Living Scale (IADL) - Patient [ Time Frame: immediately post-treatment ]
    IADL stands for "Instrumental Activities of Daily Living". Lawton's Instrumental Activities of Daily Living Scale (IADL) is an instrument to assess independent living skills (Lawton 1969). This questionnaire is supposed to be completed by the patient as well as by a person familiar with the patient. There are 8 domains of function measured with the Lawton IADL scale: Telephone, Shopping, Food preparation, Housekeeping, Laundry, Mode of transportation, Medication, Finances. The Total Score is a sum of all domains. The total score ranges from 0 (low function, dependent) to 8 (high function, independent). For male patients the highest possible score is 5 (due to expected zero scores for food preparation, housekeeping, and laundry).
  • IADL- Patient [ Time Frame: month 1 ]
    IADL stands for "Instrumental Activities of Daily Living". Lawton's Instrumental Activities of Daily Living Scale (IADL) is an instrument to assess independent living skills (Lawton 1969). This questionnaire is supposed to be completed by the patient as well as by a person familiar with the patient. There are 8 domains of function measured with the Lawton IADL scale: Telephone, Shopping, Food preparation, Housekeeping, Laundry, Mode of transportation, Medication, Finances. The Total Score is a sum of all domains. The total score ranges from 0 (low function, dependent) to 8 (high function, independent). For male patients the highest possible score is 5 (due to expected zero scores for food preparation, housekeeping, and laundry).
  • IADL- Patient [ Time Frame: month 3 ]
    IADL stands for "Instrumental Activities of Daily Living". Lawton's Instrumental Activities of Daily Living Scale (IADL) is an instrument to assess independent living skills (Lawton 1969). This questionnaire is supposed to be completed by the patient as well as by a person familiar with the patient. There are 8 domains of function measured with the Lawton IADL scale: Telephone, Shopping, Food preparation, Housekeeping, Laundry, Mode of transportation, Medication, Finances. The Total Score is a sum of all domains. The total score ranges from 0 (low function, dependent) to 8 (high function, independent). For male patients the highest possible score is 5 (due to expected zero scores for food preparation, housekeeping, and laundry).
  • Beck Depression Inventory (BDI) [ Time Frame: immediately post-treatment ]
    BDI stands for the "Beck Depression Inventory". The Beck Depression Inventory (BDI) measures the severity of depression (Beck 1961). It is a 21-item questionnaire for self-evaluation with 0-3 scores per item. The total score is the sum of all items. It ranges from 0 (normal state) to 63 (severe depression).
  • Beck Depression Inventory (BDI) [ Time Frame: month 1 ]
    BDI stands for the "Beck Depression Inventory". The Beck Depression Inventory (BDI) measures the severity of depression (Beck 1961). It is a 21-item questionnaire for self-evaluation with 0-3 scores per item. The total score is the sum of all items. It ranges from 0 (normal state) to 63 (severe depression).
  • Beck Depression Inventory (BDI) [ Time Frame: month 3 ]
    BDI stands for the "Beck Depression Inventory". The Beck Depression Inventory (BDI) measures the severity of depression (Beck 1961). It is a 21-item questionnaire for self-evaluation with 0-3 scores per item. The total score is the sum of all items. It ranges from 0 (normal state) to 63 (severe depression).
  • Prosopagnosia index (PI20) [ Time Frame: immediately post-treatment ]
    PI20 stands for the "20-item prosopagnosia index". The PI20 is a self-report instrument for identifying developmental prosopagnosia, also called face blindness. Patients indicate the extent to which 20 statements describe their face recognition experiences. Each statement is scored on a five-point scale. The total score is the sum of all scores. It ranges from 0 to 100. Higher scores reflect impairment to recognize faces.
  • Prosopagnosia index (PI20) [ Time Frame: month 1 ]
    PI20 stands for the "20-item prosopagnosia index". The PI20 is a self-report instrument for identifying developmental prosopagnosia, also called face blindness. Patients indicate the extent to which 20 statements describe their face recognition experiences. Each statement is scored on a five-point scale. The total score is the sum of all scores. It ranges from 0 to 100. Higher scores reflect impairment to recognize faces.
  • Prosopagnosia index (PI20) [ Time Frame: month 3 ]
    PI20 stands for the "20-item prosopagnosia index". The PI20 is a self-report instrument for identifying developmental prosopagnosia, also called face blindness. Patients indicate the extent to which 20 statements describe their face recognition experiences. Each statement is scored on a five-point scale. The total score is the sum of all scores. It ranges from 0 to 100. Higher scores reflect impairment to recognize faces.
  • Neuropsychiatric Inventory (NPI) (Care Taker) [ Time Frame: immediately post-treatment ]
    The NPI stands for "Neuropsychiatric Inventory". It is a questionnaire for care taker. The Neuropsychiatric Inventory (NPI) was developed to provide a means of assessing neuropsychiatric symptoms and psychopathology of patients with Alzheimer's disease and other neurodegenerative disorders (Cummings 1997). Ten behavioral and two neurovegetative areas are included in the NPI. The NPI is based on responses from an informed caregiver, preferably one living with the patient. A caregiver can be defined as a person spending at least 4 hours per day at least 4 days per week with the patient and who is knowledgeable about the patient's daytime and nighttime behaviors. The total NPI score is the sum of all items. It varies from 0 to 120 for the behavioral domains and from 0 to 144 for all 12 domains.
  • Neuropsychiatric Inventory (NPI) (Care Taker) [ Time Frame: month 1 ]
    The NPI stands for "Neuropsychiatric Inventory". It is a questionnaire for care taker. The Neuropsychiatric Inventory (NPI) was developed to provide a means of assessing neuropsychiatric symptoms and psychopathology of patients with Alzheimer's disease and other neurodegenerative disorders (Cummings 1997). Ten behavioral and two neurovegetative areas are included in the NPI. The NPI is based on responses from an informed caregiver, preferably one living with the patient. A caregiver can be defined as a person spending at least 4 hours per day at least 4 days per week with the patient and who is knowledgeable about the patient's daytime and nighttime behaviors. The total NPI score is the sum of all items. It varies from 0 to 120 for the behavioral domains and from 0 to 144 for all 12 domains.
  • Neuropsychiatric Inventory (NPI) (Care Taker) [ Time Frame: month 3 ]
    The NPI stands for "Neuropsychiatric Inventory". It is a questionnaire for care taker. The Neuropsychiatric Inventory (NPI) was developed to provide a means of assessing neuropsychiatric symptoms and psychopathology of patients with Alzheimer's disease and other neurodegenerative disorders (Cummings 1997). Ten behavioral and two neurovegetative areas are included in the NPI. The NPI is based on responses from an informed caregiver, preferably one living with the patient. A caregiver can be defined as a person spending at least 4 hours per day at least 4 days per week with the patient and who is knowledgeable about the patient's daytime and nighttime behaviors. The total NPI score is the sum of all items. It varies from 0 to 120 for the behavioral domains and from 0 to 144 for all 12 domains.
  • IADL (Care Taker) [ Time Frame: immediately post-treatment ]
    Questionnaire for care taker. IADL stands for "Instrumental Activities of Daily Living". Lawton's Instrumental Activities of Daily Living Scale (IADL) is an instrument to assess independent living skills (Lawton 1969). This questionnaire is supposed to be completed by the patient as well as by a person familiar with the patient. There are 8 domains of function measured with the Lawton IADL scale: Telephone, Shopping, Food preparation, Housekeeping, Laundry, Mode of transportation, Medication, Finances. The Total Score is a sum of all domains. The total score ranges from 0 (low function, dependent) to 8 (high function, independent). For male patients the highest possible score is 5 (due to expected zero scores for food preparation, housekeeping, and laundry).
  • IADL (Care Taker) [ Time Frame: month 1 ]
    Questionnaire for care taker. IADL stands for "Instrumental Activities of Daily Living". Lawton's Instrumental Activities of Daily Living Scale (IADL) is an instrument to assess independent living skills (Lawton 1969). This questionnaire is supposed to be completed by the patient as well as by a person familiar with the patient. There are 8 domains of function measured with the Lawton IADL scale: Telephone, Shopping, Food preparation, Housekeeping, Laundry, Mode of transportation, Medication, Finances. The Total Score is a sum of all domains. The total score ranges from 0 (low function, dependent) to 8 (high function, independent). For male patients the highest possible score is 5 (due to expected zero scores for food preparation, housekeeping, and laundry).
  • IADL (Care Taker) [ Time Frame: month 3 ]
    Questionnaire for care taker. IADL stands for "Instrumental Activities of Daily Living". Lawton's Instrumental Activities of Daily Living Scale (IADL) is an instrument to assess independent living skills (Lawton 1969). This questionnaire is supposed to be completed by the patient as well as by a person familiar with the patient. There are 8 domains of function measured with the Lawton IADL scale: Telephone, Shopping, Food preparation, Housekeeping, Laundry, Mode of transportation, Medication, Finances. The Total Score is a sum of all domains. The total score ranges from 0 (low function, dependent) to 8 (high function, independent). For male patients the highest possible score is 5 (due to expected zero scores for food preparation, housekeeping, and laundry).
  • Bayer Activities of Daily Living Scale (B-ADL) [ Time Frame: [ Time Frame: immediately post-treatment ] ]
    The B-ADL scale is used to assess deficits in the performance of everyday activities. The scale's main target group is community dwelling patients who suffer from mild cognitive impairment or mild-to-moderate dementia. It comprises 25 items. Each item is scored from 1 (no difficulties at all) to 10 (always difficulties). The global B-ADL score is the arithmetic mean of all items.
  • Bayer Activities of Daily Living Scale (B-ADL) [ Time Frame: [ Time Frame: month 1 ] ]
    The B-ADL scale is used to assess deficits in the performance of everyday activities. The scale's main target group is community dwelling patients who suffer from mild cognitive impairment or mild-to-moderate dementia. It comprises 25 items. Each item is scored from 1 (no difficulties at all) to 10 (always difficulties). The global B-ADL score is the arithmetic mean of all items.
  • Bayer Activities of Daily Living Scale (B-ADL) [ Time Frame: [ Time Frame: month 3 ] ]
    The B-ADL scale is used to assess deficits in the performance of everyday activities. The scale's main target group is community dwelling patients who suffer from mild cognitive impairment or mild-to-moderate dementia. It comprises 25 items. Each item is scored from 1 (no difficulties at all) to 10 (always difficulties). The global B-ADL score is the arithmetic mean of all items.
  • Geriatric Depression Scale - short form (GDS-15) [ Time Frame: [ Time Frame: immediately post-treatment ] ]
    The Geriatric Depression Scale (GDS) is a questionnaire to assess depression in the elderly population. This scale generates self-evaluation scores concerning various aspects with relevance for the depressive disease (e.g. mood, drive, anxiety). The short form contains 15 items. The GDS-15 score ranges from 0 (normal state) to 15 (severe depression).
  • Geriatric Depression Scale - short form (GDS-15) [ Time Frame: [ Time Frame: month 1 ] ]
    The Geriatric Depression Scale (GDS) is a questionnaire to assess depression in the elderly population. This scale generates self-evaluation scores concerning various aspects with relevance for the depressive disease (e.g. mood, drive, anxiety). The short form contains 15 items. The GDS-15 score ranges from 0 (normal state) to 15 (severe depression).
  • Geriatric Depression Scale - short form (GDS-15) [ Time Frame: [ Time Frame: month 3 ] ]
    The Geriatric Depression Scale (GDS) is a questionnaire to assess depression in the elderly population. This scale generates self-evaluation scores concerning various aspects with relevance for the depressive disease (e.g. mood, drive, anxiety). The short form contains 15 items. The GDS-15 score ranges from 0 (normal state) to 15 (severe depression).
  • Leisure Behavior (FZV; German: Freizeitverhalten) [ Time Frame: [ Time Frame: immediately post-treatment ] ]
    The leisure behavior questionnaire has 25 items covering the following activities: information / entertainment, active movement, social interactions, creative activities, church / cultural / educational activities. The frequency of each activity is rated on a Likert-Scale from 0 (never) to 6 (daily). The total score (0-6) is calculated as the average of all 25 items.
  • Leisure Behavior (FZV; German: Freizeitverhalten) [ Time Frame: [ Time Frame: month 1 ] ]
    The leisure behavior questionnaire has 25 items covering the following activities: information / entertainment, active movement, social interactions, creative activities, church / cultural / educational activities. The frequency of each activity is rated on a Likert-Scale from 0 (never) to 6 (daily). The total score (0-6) is calculated as the average of all 25 items.
  • Leisure Behavior (FZV; German: Freizeitverhalten) [ Time Frame: [ Time Frame: month 3 ] ]
    The leisure behavior questionnaire has 25 items covering the following activities: information / entertainment, active movement, social interactions, creative activities, church / cultural / educational activities. The frequency of each activity is rated on a Likert-Scale from 0 (never) to 6 (daily). The total score (0-6) is calculated as the average of all 25 items.
  • anatomical Magnetic Resonance Imaging (MRI) [ Time Frame: immediately post-treatment ]
    3 Tesla Magnetic Resonance Imaging (MRI) for safety reasons: no bleeding or anatomical changes to the brain.
  • functional Magnetic Resonance Imaging (fMRI) [ Time Frame: immediately post-treatment ]
    3 Tesla functional Magnetic Resonance Imaging (MRI) to analyze brain activation and connectivity after TPS. This will be done according to Sperling 2001.
Original Secondary Outcome Measures  ICMJE
 (submitted: December 6, 2018)
  • Alzheimer's Disease Assessment Scale (ADAS) [ Time Frame: immediately post-treatment ]
    Cognitive test. The Alzheimer's Disease Assessment Scale (ADAS) was designed to evaluate the severity of cognitive and noncognitive behavioral dysfunctions characteristic of persons with Alzheimer's disease (Rosen 1984). It consists of 21 items. Its sensitivity seems limited in mild AD (Irizarry 2008) but it is commonly used with AD intervention studies. Its cognition subscale (ADAS-COG) is a standard tool in pivotal clinical trials to detect therapeutic efficacy in cognition (Robert 2010). The ADAS-COG includes 11 items assessing the several cognitive domains. There are 70 possible points on the ADAS-COG with 0 meaning healthy.
  • Alzheimer's Disease Assessment Scale (ADAS) [ Time Frame: month 1 ]
    Cognitive test
  • Alzheimer's Disease Assessment Scale (ADAS) [ Time Frame: month 3 ]
    Cognitive test
  • Neuropsychological Test Battery Vienna (NTBV) [ Time Frame: immediately post-treatment ]
    The Neuropsychological Test Battery Vienna (NTBV) ist a cognitive test, which was created to detect Alzheimer's Disease (Lehrner 2007).
  • Neuropsychological Test Battery Vienna (NTBV) [ Time Frame: month 1 ]
    Cognitive test
  • Neuropsychological Test Battery Vienna (NTBV) [ Time Frame: month 3 ]
    Cognitive test
  • CERAD [ Time Frame: immediately post-treatment ]
    Cognitive test
  • CERAD [ Time Frame: month 1 ]
    Cognitive test
  • CERAD [ Time Frame: month 3 ]
    Cognitive test
  • Clock drawing test [ Time Frame: immediately post-treatment ]
    The clock drawing test shows the visuoconstructive skills (Shulman 1986). The subject is asked to draw the face of a clock with all numbers and to set the hands for a specified time (hh:mm). Scores range from 0 (worst) to 7 (best).
  • Clock drawing test [ Time Frame: month 1 ]
    Clock drawing test
  • Clock drawing test [ Time Frame: month 3 ]
    Clock drawing test
  • Forgetfulness assessment inventory (FAI) [ Time Frame: immediately post-treatment ]
    The Forgetfulness Assessment Inventory is a questionnaire. Kogler et al (2013) developed the forgetfulness assessment inventory FAI (German: Skala zur Erfassung der Gedächtnisleistung - SEG) to evaluate subjective complaints regarding everyday memory problems. Lehrner et al. (2014) validated the test. The FAI consists of 16 items to measure subjective memory problems in daily life based on a Likert scale. It focuses on the subjective evaluation of memory problems, particularly in relation to episodic memory, which has been found to be very sensitive in the early detection of mild cognitive impairment and AD (Lehrner 2014). This questionnaire is supposed to be completed by the patient as well as by a person familiar with the patient.
  • Forgetfulness assessment inventory (FAI) [ Time Frame: month 1 ]
    Questionnaire
  • Forgetfulness assessment inventory (FAI) [ Time Frame: month 3 ]
    Questionnaire
  • Instrumental Activities of Daily Living Scale (IADL) - Patient [ Time Frame: immediately post-treatment ]
    Lawton's Instrumental Activities of Daily Living Scale (IADL) is an instrument to assess independent living skills (Lawton 1969). This questionnaire is supposed to be completed by the patient as well as by a person familiar with the patient. There are 8 domains of function measured with the Lawton IADL scale.
    • Telephone
    • Shopping
    • Food preparation
    • Housekeeping
    • Laundry
    • Mode of transportation
    • Medication
    • Finances The summary score ranges from 0 (low function, dependent) to 8 (high function, independent) For male patients the highest possible score is 5 (due to expected zero scores for food preparation, housekeeping, and laundry).
  • IADL- Patient [ Time Frame: month 1 ]
    Activity of Daily Living Questionnaire
  • IADL- Patient [ Time Frame: month 3 ]
    Activity of Daily Living Questionnaire
  • Beck Depression Inventory (BDI) [ Time Frame: immediately post-treatment ]
    The Beck Depression Inventory measures the severity of depression (Beck 1961).It is a 21-item questionnaire for self-evaluation with 0-3 scores per item, ranging from 0 (normal state) to 63 (severe depression).
  • Beck Depression Inventory (BDI) [ Time Frame: month 1 ]
    Questionnaire
  • Beck Depression Inventory (BDI) [ Time Frame: month 3 ]
    Questionnaire
  • Prosopagnosia index [ Time Frame: immediately post-treatment ]
    The 20-item prosopagnosia index (PI20) is a self-report instrument for identifying developmental prosopagnosia, also called face blindness. Patients indicate the extent to which 20 statements describe their face recognition experiences. Each statement is scored on a five-point scale.
  • Prosopagnosia index [ Time Frame: month 1 ]
    Questionnaire
  • Prosopagnosia index [ Time Frame: month 3 ]
    Questionnaire
  • Neuropsychiatric Inventory (NPI) (Care Taker) [ Time Frame: immediately post-treatment ]
    Questionnaire for care taker. The Neuropsychiatric Inventory (NPI) was developed to provide a means of assessing neuropsychiatric symptoms and psychopathology of patients with Alzheimer's disease and other neurodegenerative disorders (Cummings 1997). Ten behavioral and two neurovegetative areas are included in the NPI. The NPI is based on responses from an informed caregiver, preferably one living with the patient. A caregiver can be defined as a person spending at least 4 hours per day at least 4 days per week with the patient and who is knowledgeable about the patient's daytime and nighttime behaviors. The total NPI score varies from 0 to 120 for the behavioral domains and from 0 to 144 for all 12 domains.
  • Neuropsychiatric Inventory (NPI) (Care Taker) [ Time Frame: month 1 ]
    Questionnaire for care taker
  • Neuropsychiatric Inventory (NPI) (Care Taker) [ Time Frame: month 3 ]
    Questionnaire for care taker
  • IADL (Care Taker) [ Time Frame: immediately post-treatment ]
    Questionnaire for care taker.
  • IADL (Care Taker) [ Time Frame: month 1 ]
    Questionnaire for care taker
  • IADL (Care Taker) [ Time Frame: month 3 ]
    Questionnaire for care taker
  • anatomical Magnetic Resonance Imaging (MRI) [ Time Frame: immediately post-treatment ]
    3 Tesla Magnetic Resonance Imaging (MRI) for safety reasons: no bleeding or anatomical changes to the brain.
  • functional Magnetic Resonance Imaging (fMRI) [ Time Frame: immediately post-treatment ]
    3 Tesla functional Magnetic Resonance Imaging (MRI) to analyze brain activation and connectivity after TPS. This will be done according to Sperling 2001.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Brain Stimulation for Neurological Patients
Official Title  ICMJE Brain Stimulation for Neurological Patients
Brief Summary This is a prospective double-blind randomized placebo-controlled crossover clinical trial
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Alzheimer Disease
Intervention  ICMJE Device: NEUROLITH
transcranial pulse stimulation (TPS)
Other Names:
  • transcranial pulse stimulation
  • TPS
Study Arms  ICMJE
  • Experimental: Group A

    NEUROLITH

    • Cycle 1: Active treatment
    • Cycle 2: Sham treatment
    Intervention: Device: NEUROLITH
  • Experimental: Group B

    NEUROLITH

    • Cycle 1: Sham treatment
    • Cycle 2: Active treatment
    Intervention: Device: NEUROLITH
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 6, 2018)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 30, 2022
Estimated Primary Completion Date September 30, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Clinically stable patients with probable Alzheimer's Disease (Diagnosis according to ICD-10 Criteria (F00))
  • At least 3 months of stable antidementive therapy or no antidementive therapy necessary
  • Signed written informed consent
  • Monthly pregnancy test for women in childbearing years
  • Age >= 18 years

Exclusion Criteria:

  • Non-compliance with the protocol
  • Pregnant or breastfeeding women
  • Relevant intracerebral pathology unrelated to the Alzheimers's disease (e.g. Brain tumor)
  • Hemophilia or other blood clotting disorders
  • Cortisone treatment within the last 6 weeks before first treatment
  • Thrombosis
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Roland Beisteiner, Prof. +43 1 401600 roland.beisteiner@meduniwien.ac.at
Listed Location Countries  ICMJE Austria
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03770182
Other Study ID Numbers  ICMJE TPS-AD-Vienna
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Storz Medical AG
Study Sponsor  ICMJE Storz Medical AG
Collaborators  ICMJE Medical University of Vienna
Investigators  ICMJE
Principal Investigator: Roland Beisteiner, Prof. Medical University of Vienna
PRS Account Storz Medical AG
Verification Date October 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP