Using rTMS to enhance thinking in Veterans with Parkinson's disease
rTMS as a Cognitive Rehabilitation Approach in Veterans With Parkinson's Disease
This study is testing whether a non-invasive brain treatment called rTMS can help improve thinking skills in Veterans with Parkinson's disease who have mild cognitive issues.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 56 (estimated) |
| Ages | 50 Years and up |
| Sex | All |
| Sponsor | VA Office of Research and Development Federal |
| Locations | 2 sites (Chicago, Illinois and 1 other locations) |
| Trial ID | NCT03836950 on ClinicalTrials.gov |
What this trial studies
This study investigates the safety and effectiveness of repetitive transcranial magnetic stimulation (rTMS) as a non-invasive treatment for Veterans suffering from Parkinson's disease or atypical parkinsonism with mild cognitive impairment. Participants will be randomly assigned to receive either active rTMS or a sham treatment, and their cognitive functions will be assessed through standardized tests at the beginning, end, and one month after the treatment. The study aims to explore changes in executive function and other cognitive domains, as well as brain connectivity using advanced neuroimaging techniques. By examining these effects, the research seeks to determine the potential of rTMS in improving cognitive outcomes for this population.
Who should consider this trial
Good fit: Ideal candidates are Veterans aged 50 and older with a diagnosis of Parkinson's disease or atypical parkinsonism and mild cognitive impairment.
Not a fit: Patients with dementia, severe depression, or those who have undergone deep brain stimulation surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly enhance cognitive function and quality of life for Veterans with Parkinson's disease.
How similar studies have performed: While rTMS has shown promise in other cognitive rehabilitation contexts, this specific application in Parkinson's disease with mild cognitive impairment is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Chicago, Illinois and 1 other locations
- Jesse Brown VA Medical Center, Chicago, IL — Chicago, Illinois, United States (Not_yet_recruiting)
- Edward Hines Jr. VA Hospital, Hines, IL — Hines, Illinois, United States (Recruiting)
Study contacts
- Principal investigator: Sandra L. Kletzel, PhD BA — Edward Hines Jr. VA Hospital, Hines, IL
- Study coordinator: Sandra L Kletzel, PhD BA
- Email: Sandra.Kletzel@va.gov
- Phone: (708) 202-5735
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.