Recruiting
Phase 1
Phase 2

rTMS

Sponsor:

VA Office of Research and Development

Code:

NCT03836950

Conditions

Parkinson's Disease

Mild Cognitive Impairment

Eligibility Criteria

Sex: All

Age: 50+

Healthy Volunteers: Not accepted

Interventions

MagVenture MagProX100 stimulator (MagVenture, Falun, Denmark)

MagVenture MagProX100 stimulator (MagVenture, Falun, Denmark)

Study Details

Brief summary:

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

Study ID

NCT03836950

Start date

Apr 1, 2020

Status verified date

Apr, 2026

Completion date

Mar 30, 2028

Anticipated

Primary completion date

Mar 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 50+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

56 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

MagVenture MagProX100 stimulator (MagVenture, Falun, Denmark)

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)

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

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 and Locations

Central contacts

Sandra L Kletzel, PhD BA

(708) 202-5735Sandra.Kletzel@va.gov

Alexandria N Umbarger, BS

(708) 998-8213alexandria.umbarger@va.gov

Locations

Edward Hines Jr. VA Hospital, Hines, IL

Recruiting

Hines, Illinois, United States, 60141-3030

Contacts

Sadie Walker, OTR

((70) 964-3805sadie.walker@va.gov

Alexandria N Umbarger, BS

(708) 998-8213alexandria.umbarger@va.gov

Principal Investigator:

Sandra L. Kletzel, PhD BA

More Information

Sponsor

VA Office of Research and Development

Last update posted

Apr 21, 2026

Last verified

Apr, 2026

Keywords

  • rTMS
  • Parkinson's disease
  • mild cognitive impairment
  • executive function
  • neuromodulation
  • functional connectivity

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by VA Office of Research and Development on 2026-04-21.