Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Brain Stimulation for Patients With Parkinson Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04333511
Recruitment Status : Recruiting
First Posted : April 3, 2020
Last Update Posted : April 7, 2020
Sponsor:
Information provided by (Responsible Party):
Storz Medical AG

Brief Summary:
The aim of this crossover study is to investigate the efficacy of non-invasive brain stimulation (transcranial pulse stimulation; TPS) in adults with Parkinson Disease (PD). Participants will receive 6 sessions of TPS and Sham-TPS, respectively, in random order. Motor manifestations of PD and manual dexterity will be the primary outcome measures. Outcomes will be assessed immediately post-treatment.

Condition or disease Intervention/treatment Phase
Parkinson Disease Device: TPS (NEUROLITH) Device: Sham-TPS (NEUROLITH) Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Brain Stimulation for Patients With Parkinson Disease
Actual Study Start Date : December 2, 2019
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Sequence 1
TPS first with crossover to Sham-TPS
Device: TPS (NEUROLITH)
6 treatments of TPS over 2 weeks

Device: Sham-TPS (NEUROLITH)
6 treatments of Sham-TPS over 2 weeks

Experimental: Sequence 2
Sham-TPS first with crossover to TPS
Device: TPS (NEUROLITH)
6 treatments of TPS over 2 weeks

Device: Sham-TPS (NEUROLITH)
6 treatments of Sham-TPS over 2 weeks




Primary Outcome Measures :
  1. Motor manifestations of Parkinson Disease [ Time Frame: Immediately post-treatment ]
    Motor manifestations of Parkinson Disease will be rated by an examiner using the relevant subscale (section III) of the Unified Parkinson Disease Rating Scale (UPDRS). This scale has 14 different types of ratings, with many of these ratings done independently for the different limbs (tremor at rest, action tremor, rigidity, bradykinesia, speech, facial expression, arising from a chair, posture, gait, postural stability, body bradykinesia). Each of the ratings ranges from 0 (normal) to 4 (severe manifestation). The total score for this scale ranges from 0 to 108, the sum of scores from 27 observations (Perlmutter 2009).

  2. Manual dexterity [ Time Frame: Immediately post-treatment ]
    Deficits in fine skilled movements will be assessed by the coin rotation test (Foki et al., 2010). A coin hast to be flipped with the first 3 fingers of one hand as fast as possible for 30 seconds. The number of successful half rotations will be determined.


Secondary Outcome Measures :
  1. Activities of daily living (ADL) [ Time Frame: Immediately post-treatment ]
    ADL will be assessed using the relevant subscale (section II) of the UPDRS. The scale consists of 13 items (speech, salivation, swallowing, handwriting, cutting food and handling utensils, dressing, hygiene, turning in bed and adjusting bedclothes, falling (unrelated to freezing), freezing when walking, walking, tremor, sensory complaints related to parkinsonism). The scoring range for each item is from 0 (normal) to 4 (severe impairment). The examiner asks the patient to describe their function separately in the ON and OFF state. The responses for each of the items are therefore scored twice. These ratings are done by the examiner based upon the responses of the patient or caregiver. The total score for subscale 2 ranges from 0 to 56 (Perlmutter 2009).

  2. Anatomical and Functional Magnetic Resonance Imaging (3 Tesla MRI) [ Time Frame: Immediately post-treatment ]
    fMRI to analyze brain activation and connectivity. Anatomical data are also used for safety evaluations: to exclude bleeding or anatomical changes of the brain

  3. Somatosensory evoked EEG Potentials (SEPs) [ Time Frame: Immediately post-stimulation ]
    In selected participants, standard EEG / EP (Electroencephalography / Evoked Potential) data will be recorded for procedural optimizations, i.e. evaluation of most promising parameter settings (energy level and pulse frequency).

  4. Bayer Activities of Daily Living Scale (B-ADL) [ 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.

  5. Leisure Behavior (FZV; German: Freizeitverhalten) [ 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.

  6. Montreal Cognitive Assessment (MOCA) [ Time Frame: Immediately post-treatment ]
    The MOCA is a screening instrument for assessing cognitive impairment. It is scored out of 30 (higher scores represent better cognition) and contains sections on visuospatial/executive, naming, memory, attention, language, abstraction, and orientation.

  7. Geriatric Depression Scale - short form (GDS-15) [ Time Frame: Immediately post-treatment ]
    he 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).

  8. 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).



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.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Clinically stable PD with fine skilled and/or gross motor deficits (e.g. right arm with a clinical force level >2)
  • 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 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): NCT04333511


Contacts
Layout table for location contacts
Contact: Roland Beisteiner, Prof. +43 1 401600 roland.beisteiner@meduniwien.ac.at

Locations
Layout table for location information
Austria
Medical University of Vienna Recruiting
Vienna, Austria
Contact: Roland Beisteiner, Prof.         
Sponsors and Collaborators
Storz Medical AG
Investigators
Layout table for investigator information
Principal Investigator: Roland Beisteiner, Prof. Medical University of Vienna
Publications:
Layout table for additonal information
Responsible Party: Storz Medical AG
ClinicalTrials.gov Identifier: NCT04333511    
Other Study ID Numbers: STU 14/032
First Posted: April 3, 2020    Key Record Dates
Last Update Posted: April 7, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases