Brain Stimulation for Patients With Parkinson Disease
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Parkinson Disease
- Sponsor
- Storz Medical AG
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Motor manifestations of Parkinson Disease
- Status
- Completed
- Last Updated
- 3 years ago
Overview
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.
Investigators
Eligibility 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
Outcomes
Primary Outcomes
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).
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.
Secondary Outcomes
- Montreal Cognitive Assessment (MOCA)(1 month post-treatment)
- Bayer Activities of Daily Living Scale (B-ADL)(1 month post-treatment)
- Leisure Behavior (FZV; German: Freizeitverhalten)(1 month post-treatment)
- Geriatric Depression Scale - short form (GDS-15)(1 month post-treatment)
- Beck Depression Inventory (BDI)(1 month post-treatment)
- Activities of daily living (ADL)(1 month post-treatment)
- Somatosensory evoked EEG Potentials (SEPs)(Immediately post-stimulation)
- Anatomical and Functional Magnetic Resonance Imaging (3 Tesla MRI)(Immediately post-treatment)