rTMS to Improve Cognition in Parkinson's
Recruiting · NCT03836950 · Interventional (participants receive a specific treatment) · Lead sponsor: VA Office of Research and Development
View the official record on ClinicalTrials.gov →Interventions studied
MagVenture MagProX100 stimulator (MagVenture, Falun, Denmark)
What this trial is about
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.
Who can take part
Age range
50 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 1, Phase 2
Study type
Interventional (participants receive a specific treatment)
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 it is running
2 locations listed across 1 US state.
- Jesse Brown VA Medical Center, Chicago, IL - Chicago, Illinois, United States
- Edward Hines Jr. VA Hospital, Hines, IL - Hines, Illinois, United States