NCT03836950

rTMS to Improve Cognition in Parkinson's

rTMS as a Cognitive Rehabilitation Approach in Veterans With Parkinson's Disease

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 56 (estimated)
• Sponsor: VA Office of Research and Development · Federal
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to examine safety, feasibility, and the behavioral and brain effects of a non-invasive treatment, repetitive transcranial magnetic stimulation (rTMS), for Veterans with Parkinson's disease or atypical parkinsonism and mild impairments in their thinking. The hypothesis is that rTMS can improve thinking for people with Parkinson's disease or atypical parkinsonism who are experiencing mild problems with their thinking ability.

Detailed description

Repetitive transcranial magnetic stimulation (rTMS) shows promise as an effective cognitive neurorehabilitation treatment. To date, no rTMS studies have assessed the effect of rTMS on cognitive function in PD-MCI. Nor has there been PD neurophysiological studies using rTMS to examine neural plasticity in cognitive neural networks. This study seeks to fill this gap by conducting a small scaled pilot randomized controlled trial (RCT) designed to assess the safety and therapeutic effects of rTMS on cognitive outcomes as well as on brain connectivity in Veterans with PD-MCI. PD-MCI participants will be randomized to either active rTMS or sham rTMS. Participants will complete a standardized neurocognitive battery assessment at baseline, endpoint and at a one month follow-up. The primary outcome is change in executive function. Secondary outcomes include performance on other cognitive domain tasks and a proximal measure of real-life function that captures relevant functional changes related to cognitive impairment in PD. Multi-modal neuroimaging, in a subsample of participants, will be used to study neural connectivity changes induced by rTMS. Changes in resting state functional connectivity, grey matter volume via voxel-based morphometry and white matter integrity via diffusion tensor imaging will be assessed at baseline and endpoint. To inform how to optimize rTMS treatment in PD-MCI, these changes will be correlated with changes in cognitive performance.

Conditions

• Parkinson's Disease
• Mild Cognitive Impairment

Interventions

Type	Name	Description
DEVICE	MagVenture MagProX100 stimulator (MagVenture, Falun, Denmark)	The coil will be held tangentially to the skull at approximately 45º from the midline. One rTMS session will consist of 40 trains of 5sec each at 110% of resting motor threshold and 15Hz will be provided at the left DLPFC.
DEVICE	MagVenture MagProX100 stimulator (MagVenture, Falun, Denmark)	The coil will be held tangentially to the skull at approximately 45º from the midline. The sham coil will not release any stimulation, but it will look, feel and sound like the real rTMS

Timeline

• Start date: 2020-04-01
• Primary completion: 2027-03-31
• Completion: 2028-03-30
• First posted: 2019-02-11
• Last updated: 2026-04-08

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study