rTMS to Improve Cognition in Parkinson's

Parkinson's Disease Clinical Trial

— TMSCogReP  

Official title:

rTMS as a Cognitive Rehabilitation Approach in Veterans With Parkinson'sDisease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03836950
• Other study ID #: N2938-W
• Secondary ID: IK2RX002938
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: April 1, 2020
• Est. completion date: June 16, 2025

Study information

• Verified date: November 2023
• Source: VA Office of Research and Development
• Contact: Sandra L Kletzel, PhD BA
• Phone: (708) 202-5735
• Email: Sandra.Kletzel[@]va.gov
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 and mild impairments in their thinking. The hypothesis is that rTMS can improve thinking for people with Parkinson's disease who are experiencing mild problems with their thinking ability.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 56
• Est. completion date: June 16, 2025
• Est. primary completion date: June 26, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

• Veterans who seek services at Hines VA Hospital or Jesse Brown VA Medical Center

• Diagnosis of PD as determined by the UK Parkinson's Disease Society Brain Bank Diagnostic Criteria

• 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

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Mild Cognitive Impairment
• Parkinson Disease
• Parkinson's Disease

Intervention

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.
• 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

Locations

Country	Name	City	State
United States	Jesse Brown VA Medical Center, Chicago, IL	Chicago	Illinois
United States	Edward Hines Jr. VA Hospital, Hines, IL	Hines	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in NIH sponsored Executive Abilities: Measures and Instruments for neurobehavioral evaluation and re-search (NIH-EXAMINER) executive composite score	The NIH-EXAMINER has an established 3-factor model defined by (1) cognitive control, (2) working memory (3) fluency. A confirmatory factor analysis indicates these 3-factors load on to 1-factor: executive composite score. Seven tests in the NIH-EXAMINER will be used to compute the composite score	baseline, 8 weeks, 12 weeks