Brain Stimulation for Patients With Parkinson Disease

Storz Medical

Status: Completed

Conditions: Parkinson Disease

Treatments: Device: Sham-TPS (NEUROLITH); Device: TPS (NEUROLITH)

Study type: Interventional

Funder types: Industry

Identifiers

NCT04333511

STU 14/032

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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30 participants in 2 patient groups

Sequence 1

Experimental group

Description:

TPS first with crossover to Sham-TPS

Treatment:

Device: Sham-TPS (NEUROLITH)

Device: TPS (NEUROLITH)

Sequence 2

Experimental group

Description:

Sham-TPS first with crossover to TPS

Treatment:

Device: Sham-TPS (NEUROLITH)

Device: TPS (NEUROLITH)