rTMS to Improve Cognitive Function in TBI

NCT02152540 | Completed Results DMC FDA Device

• 2 other identifiers: N1416-PRX13-011
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

This project will study 40 Veterans identified with symptoms understood to characterize mild to moderate Traumatic Brain Injury (TBI) including Post Traumatic Stress Disorder (PTSD). Following screening and informed consent, Veterans will be randomly assigned to treatment with repetitive Transcranial Magnetic Stimulation (rTMS) or sham rTMS (placebo). Additional examinations will compare brain imaging (structural and functional MRI scans at rest) across participants at baseline, after acute rTMS treatment, and at 6 month followup. The VA population differs significantly from populations that have been included in prior trials of rTMS for many conditions such as depression, chronic pain, and PTSD. Many returning Operation Enduring Freedom (OEF)/Operation Iraqi Freedom (OIF) personnel and Veterans with concussion histories report cognitive problems, such as impaired attention, verbal fluency, poor planning, reduced working memory, and mental flexibility. The investigators hope to show the efficacy and durability of rTMS in treating these symptoms safely in Veterans with co-morbidities.

Conditions

Traumatic Brain Injury

Keywords

TBI; Transcranial Magnetic Stimulation, Repetitive; magnetic resonance imaging functional; Quality of life; Executive Function; Veterans

Outcome Measures

Primary Outcomes (1)

• Trail Making Test Part B

  The primary hypothesis is that Veterans receiving active rTMS will show improvement more than sham treated Veterans in performance between baseline and last assessment of \>1 SD on the Trail Making Test part B. This test is known for its accurate assessment of executive function in mild and moderate TBI. The TMT is a timed test and the goal is to complete the test as accurately and as quickly as possible. Raw scores are reported in seconds to complete the test. For Part B, an average score is 75 seconds and a deficient score is greater than 273 seconds. The present study reports T-scores, which can range from a minimum of 0 and a maximum of 100. The higher the T- score achieved by a participant, the better the performance, indicating a higher level of functioning.

  Baseline (up to two weeks after screening visit); Post-Treatment (2 weeks from end of Baseline up to one month from entering the study but always the day of last treatment)

Secondary Outcomes (5)

• Sustained Improvement on Executive Function

  6-month post treatment follow up

• Change in Quality of Life (QOL) Scale

  baseline and immediately post treatment (~two weeks)

• Moderators of Response: PTSD Score

  Baseline only

• Treatment Induced Change in Functional Connectivity

  post treatment (2 weeks) and 6-months

• Change in a Mediator of Response: Brain Derived Neurotrophic Factor (BDNF)

  baseline and post treatment (2 weeks)

Study Arms (2)

ACTIVE rTMS

EXPERIMENTAL

Those receiving experimental treatment will receive 20 sessions of rTMS. The treatment will be delivered by trained medical personnel.

Device: rTMS

Sham rTMS

PLACEBO COMPARATOR

Those receiving the sham rTMS will receive 20 sessions of sham rTMS. The treatment will be delivered by trained medical personnel.

Device: Sham rTMS

Interventions

rTMS DEVICE

Repetitive Transcranial Magnetic Stimulation

ACTIVE rTMS

Sham rTMS DEVICE

Placebo Device that simulates active rTMS treatment

Sham rTMS

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Veteran of any combat era
• Both Genders
• years
• (History of (Post Traumatic Amnesia \< 1 day for mild TBI; 1 day\> x \< 7days for moderate TBI))
• Ability to obtain a Motor Threshold (MT) will be determined during the screening process.
• 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, agrees to use one of the following acceptable methods of birth control: abstinence, oral contraceptive; Norplant
• Able to read, verbalize understanding, and voluntarily sign the Informed Consent Form prior to participating in any study-specific procedures or assessments.

You may not qualify if:

• Pregnant or lactating female.
• Unable to be safely withdraw, at least two-weeks prior to treatment commencement, from medications that substantially increase the risk of having seizures
• Have a cardiac pacemaker or a cochlear implant
• Have a mass lesion, cerebral infarct or other active central nervous system (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 (as determined by chart review and intake interview)
• Current amnesic disorders, dementia, mini mental state examination (MMSE) 24 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 two months or in acute stage
• Participation in another concurrent clinical trial
• Patients with prior exposure to rTMS/ECT
• Active current suicidal intent or plan. Patient at risk for suicide will be required to establish a written safety plan involving their primary psychiatrist and the treatment team before entering the clinical trial

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

VA Palo Alto Health Care System, Palo Alto, CA

Palo Alto, California, 94304-1290, United States

Location

Related Links

• Click here for more information about this study: Repetitive Transcranial Magnetic Stimulation to Improve Cognitive Function in TBI

MeSH Terms

Conditions

Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Results Point of Contact

• Title: Dr. Maheen M. Adamson
• Organization: DVBIC, VA Palo Alto/Stanford School of Medicine

madamson@stanford.edu

6502136307

Study Officials

• Maheen M Adamson, PhD

  VA Palo Alto Health Care System, Palo Alto, CA

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2014
• First Posted: June 2, 2014
• Study Start: October 1, 2014
• Primary Completion: September 30, 2017
• Study Completion: June 30, 2019
• Last Updated: January 15, 2021
• Results First Posted: May 7, 2019

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)