Brain Stimulation for Patients With Parkinson Disease

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-02

Study Completion Date

2022-08-03

Brief Summary

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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.

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Detailed Description

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Conditions

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Parkinson Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Sequence 1

TPS first with crossover to Sham-TPS

Group Type EXPERIMENTAL

TPS (NEUROLITH)

Intervention Type DEVICE

6 treatments of TPS over 2 weeks

Sham-TPS (NEUROLITH)

Intervention Type DEVICE

6 treatments of Sham-TPS over 2 weeks

Sequence 2

Sham-TPS first with crossover to TPS

Group Type EXPERIMENTAL

TPS (NEUROLITH)

Intervention Type DEVICE

6 treatments of TPS over 2 weeks

Sham-TPS (NEUROLITH)

Intervention Type DEVICE

6 treatments of Sham-TPS over 2 weeks

Interventions

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TPS (NEUROLITH)

6 treatments of TPS over 2 weeks

Intervention Type DEVICE

Sham-TPS (NEUROLITH)

6 treatments of Sham-TPS over 2 weeks

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes