High-Definition Transcranial Direct Current Stimulation (HD-tDCS) for Sensory Deficits in Complex Traumatic Brain Injury

NCT03799458 | Completed Results DMC FDA Device

• 1 other identifier: CDMRP-PT160096
• Study Type: interventional
• Target: 79
• Locations: 1 country
• Sites: 1

Brief Summary

Aim 1: To use magnetoencephalography (MEG) and magnetic resonance imaging (MRI) in Veterans and civilians with mild traumatic brain injury (mTBI) and sensory postconcussive symptoms (PCS) to demonstrate the mechanism of therapeutic benefit of HD-tDCS for sensory symptoms, as shown by reliable changes in the activity of the cognitive control network (CCN) and sensory system network (SSN) following stimulation; Aim 2: this intervention will result in long-term improvements in measures of executive function, depression/anxiety, and quality of life.

Conditions

Mild Traumatic Brain Injury

Outcome Measures

Primary Outcomes (1)

• Postconcussive Sensory Symptoms

  The NSI is a validated scale of postconcussive symptoms; the Somatic Subscale score captures severity of physical symptoms such as tinnitus, blurry vision, loss of balance, and insomnia. (range 0-48; 0-12 mild; 13-24 moderate; 25-36 severe; 37-48 very severe)

  2 week visit

Secondary Outcomes (1)

• Magnetoencephalography Peak Activation

  2 week visit

Study Arms (3)

Active Stimulation

ACTIVE COMPARATOR

Active HD-tDCS will be delivered while subjects perform sensory training tasks.

Device: Active High-definition transcranial direct current stimulation (HD-tDCS)

Sham Stimulation

SHAM COMPARATOR

Sham HD-tDCS will be delivered while subjects perform sensory training tasks.

Device: Sham High-definition transcranial direct current stimulation (HD-tDCS)

Imaging Only

NO INTERVENTION

40 subjects will undergo initial testing only as a healthy control group.

Interventions

Active High-definition transcranial direct current stimulation (HD-tDCS) DEVICE

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.

Active Stimulation

Sham High-definition transcranial direct current stimulation (HD-tDCS) DEVICE

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

Sham Stimulation

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• are US Veteran or Active Duty Military personnel aged 18-59,
• have suffered a mild TBI (alteration in neurological functioning \< 24 hours, loss of consciousness (LOC) less than 30 minutes, Glasgow coma scale (GCS) score (if available) of between 13 and 15 acutely, and less than 24 hours of post-traumatic amnesia (PTA));
• were injured between 3 months and 15 years ago;
• have post-traumatic sensory symptoms as evidenced by endorsing at least 2 out of 12 sensory symptoms on the Neurobehavioral Symptom Inventory (NSI), a measure of post-traumatic symptoms from the NIH Common Data Elements (CDE) to a severity of "3" or higher,
• are fluent in English,
• have been on stable doses of any psychotropic medications for the past 2 months.

You may not qualify if:

• any history of moderate or severe TBI;
• a prior history of other neurological disease or any history of seizures beyond immediate post-traumatic seizure, to as to reduce risk of exacerbation of epilepsy or other neurological symptoms;
• history of psychosis, so as to reduce risk of psychiatric decompensation;
• history of current or recent (within two years) substance/alcohol dependence, to reduce confounding effects on cognition and plasticity;
• any discontinuity in skull electrical conductivity (i.e., unhealed burr holes in scalp) or artificially constructed (metal or plastic) craniotomy cover, to reduce risk of unimpeded electrical current;
• presence of any implanted electrical device (e.g. pacemaker), to reduce risk of device malfunction;
• recent medical hospitalization (within three weeks), to reduce risk of medical decompensation during the study;
• any condition that would prevent the subject from completing the protocol; 9) appointment of a legal representative, as assessed via direct inquiry of the subject and a designated trusted other, to avoid coercion of a vulnerable population;
• \) any significant blindness, to screen out peripheral sensory damage; 11) any significant deafness beyond mild hearing loss, to screen out peripheral sensory damage; 12) any ongoing litigation related to TBI, to prevent interference with legal proceedings; 13) any contraindication to MRI; 14) membership in an identified vulnerable population, including minors, pregnant women, and prisoners, so as to prevent coercion.

Sponsors & Collaborators

• University of New Mexico: lead
• Biomedical Research Institute of New Mexico: collaborator
• New Jersey Institute of Technology: collaborator
• University of Miami: collaborator
• The Mind Research Network: collaborator
• The City College of New York: collaborator

Study Sites (1)

University of New Mexico Health Sciences Center

Albuquerque, New Mexico, 87106, United States

Location

MeSH Terms

Conditions

Brain Concussion

Condition Hierarchy (Ancestors)

Brain Injuries, Traumatic; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds and Injuries; Wounds, Nonpenetrating

Results Point of Contact

• Title: Dr. Davin Quinn
• Organization: University of New Mexico Health Sciences Center

dquinn@salud.unm.edu

505-272-2223

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Active and sham HD-tDCS will be delivered with the same device, and participants and research technician are blinded to the condition.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: December 12, 2018
• First Posted: January 10, 2019
• Study Start: July 11, 2018
• Primary Completion: November 15, 2023
• Study Completion: November 15, 2023
• Last Updated: April 8, 2025
• Results First Posted: April 8, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Time Frame: Data will be uploaded to the Federal Interagency Traumatic Brain Injury Registry (FITBIR) at study termination.

Locations

US (1)