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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, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.

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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

Primary Outcome

We will develop a voxel-wise whole brain MEG source imaging approach for detecting abnormal Magnetoencephalography (MEG) slow-waves (1-4 Hz) in mTBI Veterans. The unit of the abnormal MEG source activity was measured in pico Ampere-meter (or pA-m which is 10\^(-12) A-m). Natural logarithm transformation (i.e., e-based) was used. So, the unit of the MEG source imaging was log(pA-m). The range of the voxel-wise MEG source activity scale is 0-10. High amplitude of the MEG source activity suggests m

Interventions

  • DEVICE TES

Trial Details

FieldValue
Enrollment Target 66 participants
Start Date 2017-02-01
Est. Completion 2022-09-30
Phase NA
VA Office of Research and Development

1,668 total trials

What the finished NCT03244475 record still lists

NCT03244475 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 66 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (95% lower).

The record links to 0 conditions, and to 1 intervention - of which TES is the first listed.

NCT03244475 does not publish any study locations in the registry export this page uses.

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.

How this trial's enrollment target compares

Where NCT03244475's enrollment target sits among peer trials

66 1139th of 2000 higher than 857 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03244475, the US trial registry maintained by the National Library of Medicine. NCT03244475 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.