- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04333511
Brain Stimulation for Patients With Parkinson Disease
September 30, 2022 updated by: Storz Medical AG
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Vienna, Austria
- Medical University of Vienna
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Sequence 1
TPS first with crossover to Sham-TPS
|
6 treatments of TPS over 2 weeks
6 treatments of Sham-TPS over 2 weeks
|
Experimental: Sequence 2
Sham-TPS first with crossover to TPS
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6 treatments of TPS over 2 weeks
6 treatments of Sham-TPS over 2 weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
|
Immediately post-treatment
|
Motor manifestations of Parkinson Disease
Time Frame: 1 month 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).
|
1 month post-treatment
|
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.
|
Immediately post-treatment
|
Manual dexterity
Time Frame: 1 month 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.
|
1 month post-treatment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
|
Immediately post-treatment
|
Activities of daily living (ADL)
Time Frame: 1 month 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).
|
1 month post-treatment
|
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
|
Immediately post-treatment
|
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).
|
Immediately post-stimulation
|
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.
|
Immediately post-treatment
|
Bayer Activities of Daily Living Scale (B-ADL)
Time Frame: 1 month 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.
|
1 month post-treatment
|
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.
|
Immediately post-treatment
|
Leisure Behavior (FZV; German: Freizeitverhalten)
Time Frame: 1 month 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.
|
1 month post-treatment
|
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.
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Immediately post-treatment
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Montreal Cognitive Assessment (MOCA)
Time Frame: 1 month 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.
|
1 month post-treatment
|
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).
|
Immediately post-treatment
|
Geriatric Depression Scale - short form (GDS-15)
Time Frame: 1 month 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).
|
1 month post-treatment
|
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).
|
Immediately post-treatment
|
Beck Depression Inventory (BDI)
Time Frame: 1 month 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).
|
1 month post-treatment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Roland Beisteiner, Prof., Medical University of Vienna
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Foki T, Pirker W, Klinger N, Geissler A, Rath J, Steinkellner T, Hoellinger I, Gruber S, Haubenberger D, Lehrner J, Pusswald G, Trattnig S, Auff E, Beisteiner R. FMRI correlates of apraxia in Parkinson's disease patients OFF medication. Exp Neurol. 2010 Oct;225(2):416-22. doi: 10.1016/j.expneurol.2010.07.019. Epub 2010 Jul 24.
- Perlmutter JS. Assessment of Parkinson disease manifestations. Curr Protoc Neurosci. 2009 Oct;Chapter 10:Unit10.1. doi: 10.1002/0471142301.ns1001s49.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 2, 2019
Primary Completion (Actual)
August 3, 2022
Study Completion (Actual)
August 3, 2022
Study Registration Dates
First Submitted
April 1, 2020
First Submitted That Met QC Criteria
April 1, 2020
First Posted (Actual)
April 3, 2020
Study Record Updates
Last Update Posted (Actual)
October 3, 2022
Last Update Submitted That Met QC Criteria
September 30, 2022
Last Verified
September 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STU 14/032
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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