High-Definition Transcranial Direct Current Stimulation (HD-tDCS) for Sensory Deficits in Complex Traumatic Brain Injury (NAVIGATE-TBI)
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|ClinicalTrials.gov Identifier: NCT03799458|
Recruitment Status : Recruiting
First Posted : January 10, 2019
Last Update Posted : January 10, 2019
|Condition or disease||Intervention/treatment||Phase|
|Mild Traumatic Brain Injury||Device: Active High-definition transcranial direct current stimulation (HD-tDCS) Device: Sham High-definition transcranial direct current stimulation (HD-tDCS)||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||120 subjects will be recruited for this study: 40 healthy controls subjects for the imaging-only group, and 80 mTBI subjects for the stimulation arm who have suffered mild TBI at least 3 months prior to study enrollment, but not more than 15 years prior to enrollment. The 80 mTBI subjects will be randomized to either active stimulation (40) or sham stimulation (40).|
|Masking:||Triple (Participant, Care Provider, Outcomes Assessor)|
|Masking Description:||Active and sham HD-tDCS will be delivered with the same device, and participants and research technician are blinded to the condition.|
|Official Title:||High-Definition Transcranial Direct Current Stimulation (HD-tDCS) for Sensory Deficits in Complex Traumatic Brain Injury|
|Actual Study Start Date :||July 11, 2018|
|Estimated Primary Completion Date :||September 30, 2021|
|Estimated Study Completion Date :||September 30, 2021|
Active Comparator: Active Stimulation
Active HD-tDCS will be delivered while subjects perform sensory training tasks.
Device: Active High-definition transcranial direct current stimulation (HD-tDCS)
Active HD-tDCS delivers active current through 2-10 electrodes held against the scalp with a lycra cap at specified 10-20 electroencephalography (EEG) coordinates.
Sham Comparator: Sham Stimulation
Sham HD-tDCS will be delivered while subjects perform sensory training tasks.
Device: Sham High-definition transcranial direct current stimulation (HD-tDCS)
Sham HD-tDCS delivers sham current through 2-10 electrodes held against the scalp with a lycra cap at specified 10-20 electroencephalography (EEG) coordinates
No Intervention: Imaging Only
40 subjects will undergo initial testing only as a healthy control group.
- Postconcussive sensory symptoms [ Time Frame: 2 week visit ]Somatic sub scale score from the Neurobehavioral Symptom Inventory (NSI) (range 0-48; 0-12 mild; 13-24 moderate; 25-36 severe; 37-48 very severe)
- Magnetoencephalography peak activation [ Time Frame: 2 week visit ]Peak activation during the Auditory Orienting Task (AOT) performed during magnetoencephalography
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03799458
|Contact: Lindsay Worth||505-925-7474||LWorth@salud.unm.edu|
|Contact: Davin Quinn, MD||DQuinn@salud.unm.edu|
|United States, New Mexico|
|University of New Mexico Health Sciences Center||Recruiting|
|Albuquerque, New Mexico, United States, 87106|
|Contact: Lindsay Worth 505-925-7474 LWorth@salud.unm.edu|
|Principal Investigator: Davin Quinn, MD|