rTMS to Improve Cognition in Parkinson's

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-04-01

Study Completion Date

2027-03-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Repetitive Transcranial Magnetic Stimulation for Dementia

NCT02621424

Dementia Mild Cognitive Impairment

COMPLETED NA

rTMS to Improve Cognitive Function in TBI

NCT02152540

Traumatic Brain Injury

COMPLETED NA

rTMS for Cognitive Rehabilitation After TBI

NCT03642158

Cognitive Impairment Traumatic Brain Injury

COMPLETED NA

Noninvasive Brain Stimulation for Mild Cognitive Impairment

NCT03331796

Mild Cognitive Impairment Mild Neurocognitive Disorder Cognitive Decline +5 more

COMPLETED NA

Effect of Transcranial Magnetic Stimulation on Cognition and Neural Changes in Parkinson's Disease

NCT03243214

Parkinson's Disease Mild Cognitive Impairment

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Parkinson's Disease Mild Cognitive Impairment

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

randomized control trial. Participants will receive either active or sham rTMS

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

active rTMS

For active rTMS, a butterfly coil and MagVenture MagProX100 stimulator (MagVenture, Falun, Denmark) will be used. 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.

Group Type EXPERIMENTAL

MagVenture MagProX100 stimulator (MagVenture, Falun, Denmark)

Intervention Type DEVICE

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.

sham rTMS

For sham rTMS, the procedure will be carried out at the left DLPFC but a sham coil will be used. The MagVenture coil has an active side and a placebo side allowing a double-blind study to be conducted. The sham system looks, sounds and feels like active rTMS.

Group Type SHAM_COMPARATOR

MagVenture MagProX100 stimulator (MagVenture, Falun, Denmark)

Intervention Type DEVICE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type 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

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Veterans who seek services at Hines VA Hospital or Jesse Brown VA Medical Center
* Diagnosis of PD or atypical parkinsonism as determined by a neurologist
* Meet criteria for having mild cognitive impairment
* Receiving stable (i.e., no changes in medication and medication dose) medication and who are expected to remain on stable medication for the duration of the RCT
* Speak and read English
* 50 years or older

Exclusion Criteria

* Dementia
* Failure to demonstrate decision making capacity
* History of deep brain stimulation surgery
* Severe depression
* Resting head tremor
* Dyskinesia that will interfere with collecting imaging data
* Has congestive heart failure
* Implanted cardiac pacemaker or defibrillator
* Cochlear implant, nerve stimulator, or intracranial metal clips
* Implanted medical pump
* Increased intracranial pressure
* History of claustrophobia
* Metal in eyes/face, shrapnel/bullet remnants in brain
* Participants at potential increased risk of seizure including those who have the following:

* history (or family history) of seizure or epilepsy
* history of stroke, head injury, or unexplained seizures
* presence of other neurological disease that may be associated with an altered seizure threshold

* such as CVA, cerebral aneurysm, dementia, increased intracranial pressure
* Concurrent medication use such as tricyclic antidepressants, neuroleptic medications, any other drug known to lower seizure threshold
* Secondary conditions that may significantly alter electrolyte balance or lower seizure threshold
* No quantifiable motor threshold such that rTMS dosage cannot be accurately deter-mined

Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No