Status:
RECRUITING
rTMS to Improve Cognition in Parkinson's
Lead Sponsor:
VA Office of Research and Development
Conditions:
Parkinson's Disease
Mild Cognitive Impairment
Eligibility:
All Genders
50+ years
Phase:
PHASE1
PHASE2
Brief 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 Pa...
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 functi...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 30 2027
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT03836950
Start Date
April 1 2020
End Date
March 30 2027
Last Update
September 5 2025
Active Locations (2)
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1
Jesse Brown VA Medical Center, Chicago, IL
Chicago, Illinois, United States, 60612
2
Edward Hines Jr. VA Hospital, Hines, IL
Hines, Illinois, United States, 60141-3030