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rTMS to Improve Cognition in Parkinson's (TMSCogReP)

Primary Purpose

Parkinson's Disease, Mild Cognitive Impairment

Status

Recruiting

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

MagVenture MagProX100 stimulator (MagVenture, Falun, Denmark)

About this trial

This is an interventional treatment trial for Parkinson's Disease focused on measuring rTMS, Parkinson's disease, mild cognitive impairment, executive function, neuromodulation, functional connectivity

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Veterans who seek services at Hines VA Hospital or Jesse Brown VA Medical Center
Diagnosis of PD as determined by the UK Parkinson's Disease Society Brain Bank Diagnostic Criteria
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

Sites / Locations

Jesse Brown VA Medical Center, Chicago, IL
Edward Hines Jr. VA Hospital, Hines, ILRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

active rTMS

sham rTMS

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

NCT ID

NCT03836950

First Posted

January 28, 2019

Last Updated

October 19, 2022

Sponsor

VA Office of Research and Development

1. Study Identification

Unique Protocol Identification Number

NCT03836950

Brief Title

rTMS to Improve Cognition in Parkinson's

Acronym

TMSCogReP

Official Title

rTMS as a Cognitive Rehabilitation Approach in Veterans With Parkinson'sDisease

Study Type

Interventional

2. Study Status

Record Verification Date

October 2022

Overall Recruitment Status

Recruiting

Study Start Date

April 1, 2020 (Actual)

Primary Completion Date

June 26, 2024 (Anticipated)

Study Completion Date

June 16, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

VA Office of Research and Development

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

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 and mild impairments in their thinking. The hypothesis is that rTMS can improve thinking for people with Parkinson's disease 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Parkinson's Disease, Mild Cognitive Impairment

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Model Description

randomized control trial. Participants will receive either active or sham rTMS

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

56 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

active rTMS

Arm Type

Experimental

Arm Description

Arm Title

sham rTMS

Arm Type

Sham Comparator

Arm Description

Intervention Type

Device

Intervention Name(s)

MagVenture MagProX100 stimulator (MagVenture, Falun, Denmark)

Intervention Description

The coil will be held tangentially to the skull at approximately 45� 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.

Intervention Type

Device

Intervention Name(s)

MagVenture MagProX100 stimulator (MagVenture, Falun, Denmark)

Intervention Description

The coil will be held tangentially to the skull at approximately 45� 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 Information:

Title

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

Description

Time Frame

baseline, 8 weeks, 12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Veterans who seek services at Hines VA Hospital or Jesse Brown VA Medical Center Diagnosis of PD as determined by the UK Parkinson's Disease Society Brain Bank Diagnostic Criteria 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Sandra L Kletzel, PhD BA

Phone

(708) 202-5735

Sandra.Kletzel@va.gov

First Name & Middle Initial & Last Name or Official Title & Degree

Elyse Walsh, MS

Phone

(708) 968-0427

elyse.walsh@va.gov

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sandra L. Kletzel, PhD BA

Organizational Affiliation

Edward Hines Jr. VA Hospital, Hines, IL

Official's Role

Principal Investigator

Facility Information:

Facility Name

Jesse Brown VA Medical Center, Chicago, IL

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60612

Country

United States

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Sandra L Kletzel, PhD

Phone

708-202-5735

sandra.kletzel@va.gov

First Name & Middle Initial & Last Name & Degree

Elyse Walsh, MS

Phone

7089680427

elyse.walsh@va.gov

Facility Name

Edward Hines Jr. VA Hospital, Hines, IL

City

Hines

State/Province

Illinois

ZIP/Postal Code

60141-5000

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

William Wolf, PhD

Phone

708-202-5689

William.Wolf@va.gov

First Name & Middle Initial & Last Name & Degree

Susan Andrese, MHA

Phone

(708) 202-8387

Ext

27447

Susan.Andrese@va.gov

First Name & Middle Initial & Last Name & Degree

Sandra L. Kletzel, PhD BA

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

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).

IPD Sharing Time Frame

Final data sets will be made available as per Hines VA Hospital local policy for long term storage and access until enterprise-level resources become available.

IPD Sharing Access Criteria

These data will be available upon request by researchers and scientists in accordance with federal guidelines and Hines local policy.

Learn more about this trial

rTMS to Improve Cognition in Parkinson's

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