Parkinson's DiseasePhase 1/2TMSCogRePNCT03836950
rTMS to Improve Cognition in Parkinson's
A Phase 1/2 study testing MagVenture MagProX100 stimulator (MagVenture, Falun, Denmark) in people with Parkinson's Disease and Mild Cognitive Impairment, run by VA Office of Research and Development at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Parkinson's Disease, Mild Cognitive Impairment
- What is being tested?
- MagVenture MagProX100 stimulator (MagVenture, Falun, Denmark)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Apr 2020to 30 Mar 2028
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 21Show fewer
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Not yet recruiting
Jesse Brown VA Medical Center, Chicago, IL
Chicago, Illinois, 60612
Sandra L Kletzel, PhD, 708-202-5735, sandra.kletzel@va.gov
Elyse Walsh, MS, 7089680427, elyse.walsh@va.gov
- Recruiting
Edward Hines Jr. VA Hospital, Hines, IL
Hines, Illinois, 60141-3030
Sadie Walker, OTR, ((70) 964-3805, sadie.walker@va.gov
Alexandria N Umbarger, BS, (708) 998-8213, alexandria.umbarger@va.gov
About this study
Official title: rTMS as a Cognitive Rehabilitation Approach in Veterans With Parkinson's Disease
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.
Read the detailed description
Repetitive transcranial magnetic stimulation (rTMS) shows promise as an effective cognitive neurorehabilitation treatment. To date, no rTMS studies have assessed the effect of rTMS on cognitive function in PD-MCI. Nor has there been PD neurophysiological studies using rTMS to examine neural plasticity in cognitive neural networks. This study seeks to fill this gap by conducting a small scaled pilot randomized controlled trial (RCT) designed to assess the safety and therapeutic effects of rTMS on cognitive outcomes as well as on brain connectivity in Veterans with PD-MCI. PD-MCI participants will be randomized to either active rTMS or sham rTMS. Participants will complete a standardized neurocognitive battery assessment at baseline, endpoint and at a one month follow-up. The primary outcome is change in executive function. Secondary outcomes include performance on other cognitive domain tasks and a proximal measure of real-life function that captures relevant functional changes related to cognitive impairment in PD. Multi-modal neuroimaging, in a subsample of participants, will be used to study neural connectivity changes induced by rTMS. Changes in resting state functional connectivity, grey matter volume via voxel-based morphometry and white matter integrity via diffusion tensor imaging will be assessed at baseline and endpoint. To inform how to optimize rTMS treatment in PD-MCI, these changes will be correlated with changes in cognitive performance.
- Conditions
- Parkinson's Disease, Mild Cognitive Impairment
- Being tested
- MagVenture MagProX100 stimulator (MagVenture, Falun, Denmark)
- Keywords
- rTMS, Parkinson's disease, mild cognitive impairment, executive function, neuromodulation, functional connectivity
- Medical subject headings
- Parkinson Disease, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 group | Role | What they receive |
|---|---|---|
| active rTMS | Experimental | 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. Receives: Device: MagVenture MagProX100 stimulator (MagVenture, Falun, Denmark) |
| sham rTMS | Sham comparator | 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. Receives: Device: MagVenture MagProX100 stimulator (MagVenture, Falun, Denmark) |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in NIH sponsored Executive Abilities: Measures and Instruments for neurobehavioral evaluation and re-search (NIH-EXAMINER) executive composite score
The NIH-EXAMINER has an established 3-factor model defined by (1) cognitive control, (2) working memory (3) fluency. A confirmatory factor analysis indicates these 3-factors load on to 1-factor: executive composite score. Seven tests in the NIH-EXAMINER will be used to compute the composite score
Measured: baseline, 8 weeks, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2019
- Study start1 Apr 2020
- Primary completion31 Mar 2027 (estimated)
- Study completion30 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized control trial. Participants will receive either active or sham rTMS
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Sandra L. Kletzel, PhD BA, Principal investigator, Edward Hines Jr. VA Hospital, Hines, IL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03836950
- Sponsor's protocol ID
- N2938-W
- Other IDs
- IK2RX002938, 2023CWR-NDS-831171250
- Acronym
- TMSCogReP
- Status last verified
- Apr 2026
- First submitted
- 28 Jan 2019
- Last updated
- 21 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Raw and/or normalized data will be made available in the form of Excel files. MRI images will anonymized and made available through the Northwestern University Neuroimaging Data Archive (NUNDA).
Publications
Kletzel S, Alsakaji R, Umbarger A, Walker S, Aaronson A, Herrold A, Colletta K, Bhaumik D, Weaver F, Bender Pape T. Repetitive Transcranial Magnetic Stimulation as a Cognitive Rehabilitation Approach for Veterans With Parkinson Disease and Mild Cognitive Impairment: Protocol for a Randomized Sham-Controlled Trial. JMIR Res Protoc. 2026 Jun 29;15:e77241. doi: 10.2196/77241.
PubMed 42372258
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- rTMS as a Cognitive Rehabilitation Approach in Veterans With Parkinson's Disease
- ClinicalTrials.gov ID
- NCT03836950
- Acronym / sponsor ID
- TMSCogReP / N2938-W
- Conditions
- Parkinson's Disease, Mild Cognitive Impairment
- Keywords
- rTMS, Parkinson's disease, mild cognitive impairment, executive function, neuromodulation, functional connectivity
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 1 Apr 2020 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 30 Mar 2028 (estimated)
- First posted
- 11 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Repetitive transcranial magnetic stimulation (rTMS) shows promise as an effective cognitive neurorehabilitation treatment. To date, no rTMS studies have assessed the effect of rTMS on cognitive function in PD-MCI. Nor has there been PD neurophysiological studies using rTMS to examine neural plasticity in cognitive neural networks. This study seeks to fill this gap by conducting a small scaled pilot randomized controlled trial (RCT) designed to assess the safety and therapeutic effects of rTMS on cognitive outcomes as well as on brain connectivity in Veterans with PD-MCI. PD-MCI participants will be randomized to either active rTMS or sham rTMS. Participants will complete a standardized neurocognitive battery assessment at baseline, endpoint and at a one month follow-up. The primary outcome is change in executive function. Secondary outcomes include performance on other cognitive domain tasks and a proximal measure of real-life function that captures relevant functional changes related to cognitive impairment in PD. Multi-modal neuroimaging, in a subsample of participants, will be used to study neural connectivity changes induced by rTMS. Changes in resting state functional connectivity, grey matter volume via voxel-based morphometry and white matter integrity via diffusion tensor imaging will be assessed at baseline and endpoint. To inform how to optimize rTMS treatment in PD-MCI, these changes will be correlated with changes in cognitive performance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- randomized control trial. Participants will receive either active or sham rTMS
| Arm | Type | Receives |
|---|---|---|
| active rTMS | Experimental | Device: MagVenture MagProX100 stimulator (MagVenture, Falun, Denmark)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 rTMS | Sham comparator | Device: MagVenture MagProX100 stimulator (MagVenture, Falun, Denmark)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. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (21 listed)
- Dementia
- Failure to demonstrate decision making capacity
- History of deep brain stimulation surgery
- Severe depression
- Resting head tremor
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | active rTMS |
| 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 | Device | sham rTMS |
Primary outcome
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
The NIH-EXAMINER has an established 3-factor model defined by (1) cognitive control, (2) working memory (3) fluency. A confirmatory factor analysis indicates these 3-factors load on to 1-factor: executive composite score. Seven tests in the NIH-EXAMINER will be used to compute the composite score
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2026.
- Derived from this study: PubMed 42372258Kletzel S, Alsakaji R, Umbarger A, Walker S, Aaronson A, Herrold A, Colletta K, Bhaumik D, Weaver F, Bender Pape T. Repetitive Transcranial Magnetic Stimulation as a Cognitive Rehabilitation Approach for Veterans With Parkinson Disease and Mild Cognitive Impairment: Protocol for a Randomized Sham-Controlled Trial. JMIR Res Protoc. 2026 Jun 29;15:e77241. doi: 10.2196/77241.
- Individual participant dataSharing planned: Yes. Raw and/or normalized data will be made available in the form of Excel files. MRI images will anonymized and made available through the Northwestern University Neuroimaging Data Archive (NUNDA).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sandra L. Kletzel, PhD BA principal investigator
Edward Hines Jr. VA Hospital, Hines, IL
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing MagVenture MagProX100 stimulator (MagVenture, Falun, Denmark) in people with Parkinson's Disease and Mild Cognitive Impairment, run by VA Office of Research and Development at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sandra L Kletzel, PhD BA ((708) 202-5735, Sandra.Kletzel@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03836950, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2026.