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Efficacy of Repetitive Transcranial Magnetic Stimulation for Improvement of Memory in Older Adults With TBI (ADANEW_0001)

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ClinicalTrials.gov Identifier: NCT03727737
Recruitment Status : Recruiting
First Posted : November 1, 2018
Last Update Posted : November 1, 2018
Sponsor:
Collaborators:
Stanford University
The Defense and Veterans Brain Injury Center
Information provided by (Responsible Party):
Maheen M Adamson, Palo Alto Veterans Institute for Research

Brief Summary:
The proposed study will evaluate the safety, durability and efficacy of repetitive Transcranial Magnetic Stimulation (rTMS) as a promising non-invasive therapeutic treatment for improving memory in older adults with mild or moderate Traumatic Brain Injury (TBI) who have been experiencing residual memory or cognitive problems that affect daily functioning.

Condition or disease Intervention/treatment Phase
Brain Injuries, Traumatic Repetitive Transcranial Magnetic Stimulation Memory Deficits Aging Device: Repetitive Transcranial magnetic Stimulation Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: The proposed study will evaluate the safety, durability and efficacy of repetitive Transcranial Magnetic Stimulation (rTMS) as a promising non-invasive therapeutic treatment for improving memory in older adults with mild or moderate Traumatic Brain Injury (TBI) who have been experiencing residual memory or cognitive problems that affect daily functioning.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: double blind study until trial is complete
Primary Purpose: Treatment
Official Title: Efficacy of Repetitive Transcranial Magnetic Stimulation for Improvement of Memory in Older Adults With TBI
Actual Study Start Date : October 23, 2018
Estimated Primary Completion Date : September 30, 2021
Estimated Study Completion Date : September 30, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Sham
Patients with mild and moderate TBI will be assigned randomly to this arm and will not receive treatment
Active Comparator: ACTIVE
Patients with mild and moderate TBI will be assigned randomly to this arm and will receive treatment
Device: Repetitive Transcranial magnetic Stimulation
RTMS will be delivered via magventure machine, on an approved FDA IDE protocol to DLPFC region to improve memory in older adults (veterans and non-veterans) with mild and moderate TBI.
Other Name: rTMS




Primary Outcome Measures :
  1. CANTAB Paired Associates Learning (PAL) [ Time Frame: 2-4 weeks ]
    Test for visual memory and new learning: it is a hippocampal-mediated paired associates learning task. This test has twenty-one outcome measures, covering the errors made by the participant, the number of trials required to locate the pattern(s) correctly, memory scores and stages completed (Administration time 10 minutes). The main score provided is the sum of pairs reproduced over three trials (range: 0-30). We will use the average number of trials needed to succeed on PAL task as the main outcome measure.


Secondary Outcome Measures :
  1. Functional Connectivity Changes in the Brain [ Time Frame: 2-4 weeks ]
    Neuroimaging using PET/MRI to determine Functional Connectivity in Default Mode Network (DMN) and Central Executive Network (CEN) systems in the brain following rTMS treatment. we will do this by doing ICA analysis for each network focused from the stimulation site.


Other Outcome Measures:
  1. Quality of Life measure: Short Form of Veterans Rand 36 Item Health Survey (SF/VR-36) [ Time Frame: 2-4 weeks ]
    Measure of Quality of Life change following rTMS treatment. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. We will look at these standardized eight scores as outcomes measures as well as a total composite score as an outcome measure.

  2. Sustained Improvement in primary Outcome Measure (CANTAB Paired Associates Learning (PAL)) at 6 months post-treatment [ Time Frame: 6 months ]
    At 6-month follow-up, the study primary outcome, CANTAB Paired Associate Learning task will be assessed again to identify changes that are sustained due to treatment at six-months. This test has twenty-one outcome measures, covering the errors made by the participant, the number of trials required to locate the pattern(s) correctly, memory scores and stages completed (Administration time 10 minutes). The main score provided is the sum of pairs reproduced over three trials (range: 0-30). We will use the average number of trials needed to succeed on PAL task as the main outcome measure.



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Ages Eligible for Study:   50 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 50-75 years, with a high school education
  • History of mild or moderate TBI as defined by the DoD/VA Clinical Practice Guidelines for Definition of TBI
  • Ability to obtain a Motor Threshold (MT) will be determined during the screening process
  • Must be in the chronic stable phase of recovery (>6 months post injury) with residual cognitive difficulties that are affecting daily functioning (including self-reported memory or cognition problems)
  • If on a psychotropic medication regimen, that regimen will be stable for at least 4 weeks prior to entry to the study and patient will be willing to remain on a stable regimen during the acute treatment phase
  • Has an adequately stable condition and environment to enable attendance at scheduled clinic visits
  • For female participants of child bearing potential, agrees to use one of the following acceptable methods of birth control: abstinence, oral contraceptive, Norplant, Depo-Provera, a condom with spermicide, a cervical cap with spermicide, a diaphragm with spermicide, an intrauterine device, surgical sterilization (having your tubes tied)
  • Able to read, verbalize understanding, and voluntarily sign the Informed Consent Form prior to participating in any study-specific procedures or assessments
  • Individuals who meet the study criteria but have impaired decision making capacity may participate provided they are able to voluntarily sign an Assent Form and have an LAR who can sign a Consent Form and accompany the participant to all study visits

Exclusion Criteria:

  • Diagnosed with Dementia
  • Pregnant or lactating female.
  • Unable to be safely withdrawn, at least two-weeks prior to beginning treatment, from medications that substantially increase the risk of seizures
  • Have a cardiac pacemaker or a cochlear implant
  • Have an implanted device (deep brain stimulation) or metal in the brain (see standard MRI exclusion criteria including metal screening section in telephone screen, Appendix A)
  • Have a mass lesion, cerebral infarct or other active CNS disease, including a seizure disorder
  • Known current psychosis as determined by DSM-IV coding in chart (Axis I, psychotic disorder, schizophrenia) or a history of a non-mood psychotic disorder
  • Diagnosis of Bipolar Affective Disorder I (as determined by chart review and intake interview), since this in conjunction with TBI increases seizure risk
  • Current amnesic disorders, dementia, MOCA ≤ 16, or delirium.
  • Current substance abuse (not including caffeine or nicotine) as determined by positive toxicology screen, or by history via AUDIT, within 3 months prior to screening
  • Prior history of seizures
  • Severe TBI or open head injury
  • TBI within last 6 months
  • Participation in another concurrent clinical trial
  • Patients with prior exposure to rTMS (NOTE: TMS is allowed) or ECT
  • Active current suicidal intent or plan. Patients at risk for suicide will be required to establish a written safety plan involving their primary psychiatrist. All patients at risk for suicide will be excluded from the study (as per FDA recommendation).

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): NCT03727737


Contacts
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Contact: Maheen M Adamson, PhD 6502136307 madamson@stanford.edu
Contact: Harlene Grewal 650-852-3233 Harlene.Grewal@va.gov

Locations
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United States, California
VA Palo Alto Health Care System Recruiting
Palo Alto, California, United States, 94304
Contact: Harlene Grewal, BA    650-852-3233    Harlene.Grewal@va.gov   
Sponsors and Collaborators
Palo Alto Veterans Institute for Research
Stanford University
The Defense and Veterans Brain Injury Center

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Responsible Party: Maheen M Adamson, Senior Scientific Research Director, Defense and Veterans Brain Injury Center (DVBIC), Palo Alto Veterans Institute for Research
ClinicalTrials.gov Identifier: NCT03727737     History of Changes
Other Study ID Numbers: ADANEW_0001
First Posted: November 1, 2018    Key Record Dates
Last Update Posted: November 1, 2018
Last Verified: October 2018

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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
Keywords provided by Maheen M Adamson, Palo Alto Veterans Institute for Research:
repetitive Transcranial Magnetic Stimulation
Brain Injuries, Traumatic
Additional relevant MeSH terms:
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Brain Injuries
Brain Injuries, Traumatic
Memory Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms