rTMS to Improve Cognition in Parkinson's

Part of paid clinical trials in Chicago, Illinois.

Sponsor
VA Office of Research and Development
Study ID
NCT03836950
Phase
PHASE1/PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
50 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • MagVenture MagProX100 stimulator (MagVenture, Falun, Denmark) — DEVICE
    The coil will be held tangentially to the skull at approximately 45º from the midline. 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.
  • MagVenture MagProX100 stimulator (MagVenture, Falun, Denmark) — DEVICE
    The coil will be held tangentially to the skull at approximately 45º from the midline. The sham coil will not release any stimulation, but it will look, feel and sound like the real rTMS

Study Details

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.

Key Dates

Start date
Apr 1, 2020
Status verified
Apr 2026
Primary completion
Mar 31, 2027
Completion
Mar 30, 2028

Study Design

Enrollment
56 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: active rTMS
    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.
  • Sham Comparator: sham rTMS
    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.

Primary Outcome Measure

change in NIH sponsored Executive Abilities: Measures and Instruments for neurobehavioral evaluation and re-search (NIH-EXAMINER) executive composite score [ Time Frame: baseline, 8 weeks, 12 weeks ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Jesse Brown VA Medical Center, Chicago, ILChicagoIllinois60612
Sandra L Kletzel, PhD
[email protected]
708-202-5735
Elyse Walsh, MS
[email protected]
7089680427
Edward Hines Jr. VA Hospital, Hines, ILHinesIllinois60141-3030
Sadie Walker, OTR
[email protected]
((70) 964-3805
Alexandria N Umbarger, BS
[email protected]
(708) 998-8213
Sandra L. Kletzel, PhD BA (PRINCIPAL_INVESTIGATOR)

Find similar trials in Chicago, IL

By condition
Parkinson's disease
By specialty
NeurologyBrain disorders
By research site
Jesse Brown VA Medical Center, Chicago, IL· Chicago, ILEdward Hines Jr. VA Hospital, Hines, IL· Hines, IL

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