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Trial record 22 of 66 for:    Behaviors and Mental Disorders[CONDITION-BROWSE-BRANCH] | Recruiting, Not yet recruiting, Available Studies | ( Map: Illinois, United States ) | NIH, U.S. Fed

rTMS to Improve Cognition in Parkinson's (TMSCogReP)

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ClinicalTrials.gov Identifier: NCT03836950
Recruitment Status : Not yet recruiting
First Posted : February 11, 2019
Last Update Posted : February 11, 2019
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

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.

Condition or disease Intervention/treatment Phase
Parkinson's Disease Mild Cognitive Impairment Device: MagVenture MagProX100 stimulator (MagVenture, Falun, Denmark) Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 166 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: randomized control trial. Participants will receive either active or sham rTMS
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: rTMS as a Cognitive Rehabilitation Approach in Veterans With Parkinson's Disease
Estimated Study Start Date : June 28, 2019
Estimated Primary Completion Date : June 26, 2024
Estimated Study Completion Date : June 16, 2025

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
Device: MagVenture MagProX100 stimulator (MagVenture, Falun, Denmark)
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.

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.
Device: MagVenture MagProX100 stimulator (MagVenture, Falun, Denmark)
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 Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Veterans who seek services at Hines VA Hospital
  • 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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03836950


Contacts
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Contact: Sandra L Kletzel, PhD BA (708) 202-5735 Sandra.Kletzel@va.gov
Contact: Amy A Herrold, PhD BA (708) 202-5867 amy.herrold@va.gov

Locations
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United States, Illinois
Jesse Brown VA Medical Center, Chicago, IL Not yet recruiting
Chicago, Illinois, United States, 60612
Contact: Sandra L Kletzel, PhD    708-202-5735    sandra.kletzel@va.gov   
Contact: Amy A Herrold    7082025867    amy.herrold@va.gov   
Edward Hines Jr. VA Hospital, Hines, IL Not yet recruiting
Hines, Illinois, United States, 60141-5000
Contact: William Wolf, PhD    708-202-8387    William.Wolf@va.gov   
Contact: Susan Andrese, MHA    (708) 202-8387 ext 27447    Susan.Andrese@va.gov   
Principal Investigator: Sandra L. Kletzel, PhD BA         
Sponsors and Collaborators
VA Office of Research and Development
Investigators
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Principal Investigator: Sandra L. Kletzel, PhD BA Edward Hines Jr. VA Hospital, Hines, IL

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Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT03836950     History of Changes
Other Study ID Numbers: N2938-W
IK2RX002938 ( U.S. NIH Grant/Contract )
First Posted: February 11, 2019    Key Record Dates
Last Update Posted: February 11, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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).
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.
Access Criteria: These data will be available upon request by researchers and scientists in accordance with federal guidelines and Hines local policy.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by VA Office of Research and Development:
rTMS
Parkinson's disease
mild cognitive impairment
executive function
neuromodulation
functional connectivity

Additional relevant MeSH terms:
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Parkinson Disease
Cognitive Dysfunction
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Cognition Disorders
Neurocognitive Disorders
Mental Disorders