Clinical trial NCT04333511: Brain Stimulation for Patients With Parkinson Disease
Official title: Brain Stimulation for Patients With Parkinson Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Lead sponsor: Storz Medical AG
Sponsor class: INDUSTRY
First posted: 2020-04-03
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Motor manifestations of Parkinson Disease
timeFrame: Immediately post-treatment
measure: Motor manifestations of Parkinson Disease
timeFrame: 1 month post-treatment
measure: Manual dexterity
timeFrame: Immediately post-treatment
measure: Manual dexterity
timeFrame: 1 month post-treatment
Secondary outcomes:
measure: Activities of daily living (ADL)
timeFrame: Immediately post-treatment
measure: Activities of daily living (ADL)
timeFrame: 1 month post-treatment
measure: Anatomical and Functional Magnetic Resonance Imaging (3 Tesla MRI)
timeFrame: Immediately post-treatment
measure: Somatosensory evoked EEG Potentials (SEPs)
timeFrame: Immediately post-stimulation
measure: Bayer Activities of Daily Living Scale (B-ADL)
timeFrame: Immediately post-treatment
measure: Bayer Activities of Daily Living Scale (B-ADL)
timeFrame: 1 month post-treatment
measure: Leisure Behavior (FZV; German: Freizeitverhalten)
timeFrame: Immediately post-treatment
measure: Leisure Behavior (FZV; German: Freizeitverhalten)
timeFrame: 1 month post-treatment
measure: Montreal Cognitive Assessment (MOCA)
timeFrame: Immediately post-treatment
measure: Montreal Cognitive Assessment (MOCA)
timeFrame: 1 month post-treatment
measure: Geriatric Depression Scale - short form (GDS-15)
timeFrame: Immediately post-treatment
measure: Geriatric Depression Scale - short form (GDS-15)
timeFrame: 1 month post-treatment
measure: Beck Depression Inventory (BDI)
timeFrame: Immediately post-treatment
measure: Beck Depression Inventory (BDI)
timeFrame: 1 month post-treatment
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna
Study officials:
affiliation: Medical University of Vienna
name: Roland Beisteiner, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Perlmutter JS. Assessment of Parkinson disease manifestations. Curr Protoc Neurosci. 2009 Oct;Chapter 10:Unit10.1. doi: 10.1002/0471142301.ns1001s49.