rTMS as a Cognitive Rehabilitation Approach in Veterans With Parkinson's Disease

Trial ID: NCT03836950

Interventional - Phase 1/2 - Recruiting

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.

Conditions

• Parkinson's Disease
• Mild Cognitive Impairment

Interventions

• MagVenture MagProX100 stimulator (MagVenture, Falun, Denmark)
• MagVenture MagProX100 stimulator (MagVenture, Falun, Denmark)

Eligibility

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

Sponsor

VA Office of Research and Development

Source: ClinicalTrials.gov

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