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 : March 4, 2020
|Condition or disease||Intervention/treatment||Phase|
|Brain Injuries, Traumatic Repetitive Transcranial Magnetic Stimulation Memory Deficits Aging||Device: Repetitive Transcranial magnetic Stimulation||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|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|
|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|
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
- 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.
- 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.
- 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.
- 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.
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
|Contact: Maheen M Adamson, PhDemail@example.com|
|Contact: Harlene Grewal||650-852-3233||Harlene.Grewal@va.gov|
|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|