CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 26 enrolled
Drug / intervention
transcranial direct current stimulationdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04012853
NCT04012853N/ACompleted

Remotely Supervised Transcranial Direct Current Stimulation for Persistent Post-traumatic Headache: A Pilot Study

VA Office of Research and Development·interventional·Posted Jul 9, 2019·Updated Apr 14, 2023

In Brief

A clinical study evaluating transcranial direct current stimulation for Persistent Post Traumatic Headache and Mild Traumatic Brain Injury. Completed, enrolled 26 participants across 1 site.

Detailed Summary

This pilot study is designed to provide preliminary data for a large scale, randomized clinical trial to evaluate the efficacy of remotely administrated at home transcranial Direct Current Stimulation (tDCS) with real-time monitoring via VA Tele-health for persistent post traumatic headache associated with mild traumatic brain injury (mTBI). Participants will receive total of 20 sessions of tDCS over four weeks. The investigators anticipate that the results generated from the study will directly translate into immediate meaningful clinical application: not only in management of chronic post traumatic headache, but also in reduction of acute pain medication use, and improving quality of life for our veterans with this debilitating neurological disorder.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
CollaboratorsNew York University

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedJul 9, 2019
Enrollment StartNov 4, 2019
Primary CompletionMar 31, 2022
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 7.0 years ago

Interventions

transcranial direct current stimulationdevice

Treatment group will receive 20 minutes of tDCS stimulation at 2.0 mA administered daily for five days per week and a total of 4 weeks. During the 20minute treatment session, both treatment and sham groups will complete mindfulness meditation via VA health system approved program (Mindfulness Coach).