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Trial record 50 of 321 for:    Recruiting, Not yet recruiting, Available Studies | "Brain Injuries, Traumatic"

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
Sponsor:
Collaborators:
Biomedical Research Institute of New Mexico
New Jersey Institute of Technology
University of Miami
The Mind Research Network
The City College of New York
Information provided by (Responsible Party):
University of New Mexico

Brief Summary:
Aim 1: To use magnetoencephalography (MEG) and magnetic resonance imaging (MRI) in Veterans and Active Duty Service members 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.

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
Allocation: Randomized
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.
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. Magnetoencephalography peak activation [ Time Frame: 2 week visit ]
    Peak activation during the Auditory Orienting Task (AOT) performed during magnetoencephalography



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Ages Eligible for Study:   18 Years to 59 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. are US Veteran or Active Duty Military personnel aged 18-59,
  2. 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));
  3. were injured between 3 months and 15 years ago;
  4. 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,
  5. are fluent in English,
  6. have been on stable doses of any psychotropic medications for the past 2 months.
  7. The imaging-only group will have the same inclusion and exclusion criteria except they will not have had a head injury.

Exclusion Criteria:

  1. any history of moderate or severe TBI;
  2. 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;
  3. history of psychosis, so as to reduce risk of psychiatric decompensation;
  4. history of current or recent (within two years) substance/alcohol dependence, to reduce confounding effects on cognition and plasticity;
  5. 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;
  6. presence of any implanted electrical device (e.g. pacemaker), to reduce risk of device malfunction;
  7. recent medical hospitalization (within three weeks), to reduce risk of medical decompensation during the study;
  8. 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;

10) 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.


Information from the National Library of Medicine

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


Contacts
Contact: Lindsay Worth 505-925-7474 LWorth@salud.unm.edu
Contact: Davin Quinn, MD DQuinn@salud.unm.edu

Locations
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         
Sponsors and Collaborators
University of New Mexico
Biomedical Research Institute of New Mexico
New Jersey Institute of Technology
University of Miami
The Mind Research Network
The City College of New York

Responsible Party: University of New Mexico
ClinicalTrials.gov Identifier: NCT03799458     History of Changes
Other Study ID Numbers: CDMRP-PT160096
First Posted: January 10, 2019    Key Record Dates
Last Update Posted: January 10, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified participant data, including demographic, neuropsychological, and imaging data, will be uploaded to FITBIR for use by TBI researchers, as specified by the grant sponsor.
Time Frame: Data will be uploaded to the Federal Interagency Traumatic Brain Injury Registry (FITBIR) at study termination.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Brain Injuries, Traumatic
Wounds and Injuries
Brain Injuries
Brain Concussion
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Head Injuries, Closed
Wounds, Nonpenetrating