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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 : December 13, 2018
Sponsor:
Collaborator:
Medical University of Vienna
Information provided by (Responsible Party):
Storz Medical AG

Brief Summary:
This is a prospective double-blind randomized placebo-controlled crossover clinical trial

Condition or disease Intervention/treatment Phase
Alzheimer Disease Device: NEUROLITH Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Brain Stimulation for Neurological Patients
Actual Study Start Date : January 24, 2017
Estimated Primary Completion Date : January 1, 2020
Estimated Study Completion Date : January 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Group A

NEUROLITH

  • Cycle 1: Active treatment
  • Cycle 2: Sham treatment
Device: NEUROLITH
transcranial pulse stimulation (TPS)
Other Names:
  • transcranial pulse stimulation
  • TPS

Experimental: Group B

NEUROLITH

  • Cycle 1: Sham treatment
  • Cycle 2: Active treatment
Device: NEUROLITH
transcranial pulse stimulation (TPS)
Other Names:
  • transcranial pulse stimulation
  • TPS




Primary Outcome Measures :
  1. 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".



Secondary Outcome Measures :
  1. 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.


  2. 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.


  3. 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.


  4. 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).

  5. Neuropsychological Test Battery Vienna (NTBV) [ Time Frame: month 1 ]
    Cognitive test

  6. Neuropsychological Test Battery Vienna (NTBV) [ Time Frame: month 3 ]
    Cognitive test

  7. CERAD [ Time Frame: immediately post-treatment ]
    Cognitive test

  8. CERAD [ Time Frame: month 1 ]
    Cognitive test

  9. CERAD [ Time Frame: month 3 ]
    Cognitive test

  10. 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).

  11. Clock drawing test [ Time Frame: month 1 ]
    Clock drawing test

  12. Clock drawing test [ Time Frame: month 3 ]
    Clock drawing test

  13. 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.


  14. 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.


  15. 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.


  16. 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).


  17. 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).


  18. 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).


  19. 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).

  20. 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).

  21. 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).

  22. 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.

  23. 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.

  24. 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.

  25. 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.


  26. 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.


  27. 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.


  28. 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).


  29. 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).


  30. 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).


  31. 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.

  32. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03770182


Contacts
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Contact: Roland Beisteiner, Prof. +43 1 401600 roland.beisteiner@meduniwien.ac.at

Locations
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Austria
Medical University of Vienna Recruiting
Vienna, Austria
Sponsors and Collaborators
Storz Medical AG
Medical University of Vienna
Investigators
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Principal Investigator: Roland Beisteiner, Prof. Medical University of Vienna

Publications:
Lehrner, J.; Maly, J.; Gleiß, A.; Auff, E. & Dal-Bianco, P., Demenzdiagnostik mit Hilfe der Vienna Neuropsychologischen Testbatterie (VNTB): Standardisierung, Normierung und Validierung, Psychol. Österreich, 4, 358-365, 2007.
Shulman, K. I.; Shedletsky, R. & Silver, I. L.The challenge of time: Clock-drawing and cognitive function in the elderly. International journal of geriatric psychiatry, Wiley Online Library 1: 135-140, 1986.
Kogler, B. Subjective Memory Complaint in Mild Cognitive Impairment, Alzheimer's Disease and Parkinson's Disease. Vienna: University of Vienna, 2013

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Responsible Party: Storz Medical AG
ClinicalTrials.gov Identifier: NCT03770182     History of Changes
Other Study ID Numbers: TPS-AD-Vienna
First Posted: December 10, 2018    Key Record Dates
Last Update Posted: December 13, 2018
Last Verified: December 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders