N/A
N=33
rTMS to Improve Cognitive Function in TBI
Traumatic Brain Injury
Bottom Line
View on ClinicalTrials.gov: NCT02152540 ↗Enrolled (actual)
33
Serious AEs
0.0%
Results posted
May 2019
Primary outcome: Primary: Trail Making Test Part B — 52.1; 45.3; 52.9; 50.8 T-score
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- rTMS (Device); Sham rTMS (Device)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- Sep 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Trail Making Test Part B |
52.1; 45.3; 52.9; 50.8 | — |
| SECONDARY Sustained Improvement on Executive Function |
51.3; 51.2 | — |
| SECONDARY Change in Quality of Life (QOL) Scale |
59.0; 58.1 | — |
| SECONDARY Moderators of Response: PTSD Score |
41.8; 38.7 | — |
| SECONDARY Treatment Induced Change in Functional Connectivity |
-0.81; 0.34 | — |
| SECONDARY Change in a Mediator of Response: Brain Derived Neurotrophic Factor (BDNF) |
-0.31; 0.25 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Veteran of any combat era
- Both Genders
- 20-65years
- (History of (Post Traumatic Amnesia 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.
Exclusion Criteria
- 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 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 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
Data sourced from ClinicalTrials.gov (NCT02152540). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.