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Non-invasive Brain Stimulation

rTMS for Cognitive Impairment in Parkinson's Disease (TMSCogReP Trial)

Phase 1 & 2

Recruiting

Led By Sandra L. Kletzel, PhD BA

Research Sponsored by VA Office of Research and Development

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

50 years or older

Be older than 18 years old

Must not have

Concurrent medication use such as tricyclic antidepressants, neuroleptic medications, any other drug known to lower seizure threshold

Resting head tremor

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 8 weeks, 12 weeks

Summary

This trial will test whether a non-invasive brain stimulation treatment can improve thinking for people with Parkinson's disease who have mild cognitive impairments.

Who is the study for?

This trial is for Veterans over 50 with Parkinson's disease who have mild cognitive impairment, can speak and read English, and are treated at Hines VA Hospital or Jesse Brown VA Medical Center. Participants must be on stable medication that won't change during the study. Those with severe depression, dementia, certain implants, history of seizures or metal in their body cannot join.

What is being tested?

The trial tests if repetitive transcranial magnetic stimulation (rTMS) using a MagVenture MagProX100 stimulator can improve thinking abilities in those with Parkinson's experiencing mild cognitive issues. It assesses the safety and effects of rTMS on behavior and brain function.

What are the potential side effects?

Potential side effects may include discomfort at the stimulation site, headache, lightheadedness, or twitching facial muscles during treatment. There's also a small risk of seizure but this is rare.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 50 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not taking medications known to increase the risk of seizures.

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I have a shaking head when I am not moving it.

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I have a brain condition that could make seizures more likely.

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I have been diagnosed with congestive heart failure.

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I or someone in my family has had seizures or epilepsy.

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I have been diagnosed with severe depression.

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I have had a stroke, head injury, or seizures without a known cause.

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I have had deep brain stimulation surgery.

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I am unable to make decisions for my own care.

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My movements are too uncontrolled for clear imaging tests.

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I have high pressure inside my skull.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 8 weeks, 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 8 weeks, 12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 8 weeks, 12 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

change in NIH sponsored Executive Abilities: Measures and Instruments for neurobehavioral evaluation and re-search (NIH-EXAMINER) executive composite score

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: active rTMSExperimental Treatment1 Intervention

For active rTMS, a butterfly coil and MagVenture MagProX100 stimulator (MagVenture, Falun, Denmark) will be used. 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.

Group II: sham rTMSPlacebo Group1 Intervention

For sham rTMS, the procedure will be carried out at the left DLPFC but a sham coil will be used. The MagVenture coil has an active side and a placebo side allowing a double-blind study to be conducted. The sham system looks, sounds and feels like active rTMS.

0 / 12Eligibility criteria met