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NCT03244475 · ClinicalTrials.gov registry record · NA
Transcranial Electrical Stimulation for mTBI
A NA study, sponsored by VA Office of Research and Development.
- Completed
- Registry status
- NA
- Development phase
- 66
- Enrollment target
NCT03244475: Completed NA study, sponsored by VA Office of Research and Development.
NCT03244475 is a NA study that has completed, run by VA Office of Research and Development. The registered enrollment target is 66 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03244475, a NA study, has completed, sponsored by VA Office of Research and Development.
- COMPLETED
- Registry status
- NA
- Development phase
- 66 participants
- Enrollment target
Study Summary
mTBI is a leading cause of sustained physical, cognitive, emotional, and behavioral deficits in OEF/OIF/OND Veterans and the general public. However, the underlying pathophysiology is not completely understood, and there are few effective treatments for post-concussive symptoms (PCS). In addition, there are substantial overlaps between PCS and PTSD symptoms in mTBI. IASIS is among a class of passive neurofeedback treatments that combine low-intensity pulses for transcranial electrical stimulation (LIP-tES) with EEG monitoring. Nexalin is another tES technique , with FDA approvals for treating insomnia, depression, and anxiety. LIP-tES techniques have shown promising results in alleviating PCS individuals with TBI. However, the neural mechanisms underlying the effects of LIP-tES treatment in TBI are unknown, owing to the dearth of neuroimaging investigations of this therapeutic intervention. Conventional neuroimaging techniques such as MRI and CT have limited sensitivity in detecting physiological abnormalities caused by mTBI, or in assessing the efficacy of mTBI treatments. In acute and chronic phases, CT and MRI are typically negative even in mTBI patients with persistent PCS. In contrast, evidence is mounting in support of resting-state magnetoencephalography (rs-MEG) slow-wave source imaging (delta-band, 1-4 Hz) as a marker for neuronal abnormalities in mTBI. The primary goal of the present application is to use rs-MEG to identify the neural underpinnings of behavioral changes associated with IASIS treatment in Veterans with mTBI. Using a double-blind placebo controlled design, the investigators will study changes in abnormal MEG slow-waves before and after IASIS treatment (relative to a 'sham' treatment group) in Veterans with mTBI. For a subset of participants who may have remaining TBI symptoms at the end of all IASIS treatment sessions, MEG slow-wave changes will be recorded before and after additional Nexalin treatment. In addition, the investigators will ex
Interventions
- DEVICE TES
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 66 participants |
| Start Date | 2017-02-01 |
| Est. Completion | 2022-09-30 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03244475
The ClinicalTrials.gov registry entry for NCT03244475 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 66 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is VA Office of Research and Development, which has 1,668 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which TES is the first listed.
NCT03244475 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03244475 about?
NCT03244475 is a clinical study titled "Transcranial Electrical Stimulation for mTBI". mTBI is a leading cause of sustained physical, cognitive, emotional, and behavioral deficits in OEF/OIF/OND Veterans and the general public. However, the underlying pathophysiology is not completely understood, and there are few effective treatments for post-concussive symptoms (PCS). In addition, t...
What is the current status of trial NCT03244475?
This trial is currently completed. It is a NA study. The enrollment target is 66 participants. The study started on 2017-02-01. Estimated completion is 2022-09-30.
What interventions are being tested in trial NCT03244475?
The interventions under investigation include: TES (DEVICE).
Who is sponsoring clinical trial NCT03244475?
This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.
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