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tDCS and Cognitive Training in Active Duty Service Members With Mild TBI: A Pilot Study

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Conditions

Brain ConcussionBrain TraumaAttention Concentration DifficultyBrain InjuriesBrain Injuries, TraumaticNeurocognitive DysfunctionAttention ImpairedMemory ImpairmentMild Traumatic Brain InjuryMild Cognitive Impairmentmilitary healthbrain stimulationcognitive trainingcognitive rehabilitation

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The proposed study will evaluate a new approach to cognitive rehabilitation of mild traumatic brain injury (mTBI) using a brain stimulation technique called transcranial direct current stimulation (tDCS). Specifically, we will investigate how tDCS combined with cognitive training improves deficits to attention and working memory in Active Duty Service Members with a history of mild traumatic brain injury (TBI). Measures of attention-related brain activity, neurocognitive assessments, and self-reported clinical outcomes will be used to determine effects of tDCS vs. sham tDCS when paired with a cognitive training intervention. By doing this study, we hope to find a reliable, noninvasive, and efficient method of treating mild TBI cognitive symptoms.

Official Title

Transcranial Direct Current Stimulation (tDCS) and Cognitive Training to Improve Concentration and Working Memory in Active Duty Service Members Following Mild Traumatic Brain Injury (mTBI): A Pilot Study

Quick Facts

Study Start:2021-01-19
Study Completion:2025-07-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT04925453

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 55 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * (1) Have a remote history mild traumatic brain injury as defined by the VA/DoD clinical practice guidelines(The Management of Concussion/mTBI Working Group, 2016) that is \>/= 6 months, and report moderate severity neurocognitive symptoms related to attention, concentration, working memory, or memory based on NSI scores and self-report.
  2. * (2) Are between the ages of 18-55.
  3. * (3) Are stable on any medications for at least 2 weeks at the baseline visit (Visit #1).
  1. * (1) Have a history of seizures or epilepsy.
  2. * (2) Have a history of ECT or cortical energy exposure within the past 12 months, including participation in any other neuromodulation studies.
  3. * (3) Have current stimulant dependence.
  4. * (4) Have a diagnosis of intellectual disability or pervasive developmental disorder (i.e. premorbid IQ less than or equal to 70).
  5. * (5) Have any medical condition or treatment other than mild TBI (e.g. stroke, tumor, HIV, moderate-severe TBI), with significant neurological disorder or insults that, based on the Principal Investigator's judgement, would impact risk.
  6. * (6) Diagnosed with current active psychosis or mania.
  7. * (7) Have metallic cranial plates/screws or implanted device,
  8. * (8) Have eczema on scalp or other scalp lesions or skin disorders that may become irritated by stimulation.
  9. * (9) Pregnant individuals and individuals with ferromagnetic metal in their body that would prohibit them from being safe in the MRI will not be excluded from the overall study, but will be excluded from the optional MRI.

Contacts and Locations

Principal Investigator

Lars D Hungerford, PhD
PRINCIPAL_INVESTIGATOR
United States Naval Medical Center, San Diego

Study Locations (Sites)

Naval Medical Center San Diego
San Diego, California, 92134
United States

Collaborators and Investigators

Sponsor: United States Naval Medical Center, San Diego

  • Lars D Hungerford, PhD, PRINCIPAL_INVESTIGATOR, United States Naval Medical Center, San Diego

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-01-19
Study Completion Date2025-07-30

Study Record Updates

Study Start Date2021-01-19
Study Completion Date2025-07-30

Terms related to this study

Keywords Provided by Researchers

  • military health
  • brain stimulation
  • cognitive training
  • cognitive rehabilitation

Additional Relevant MeSH Terms

  • Brain Concussion
  • Brain Trauma
  • Attention Concentration Difficulty
  • Brain Injuries
  • Brain Injuries, Traumatic
  • Neurocognitive Dysfunction
  • Attention Impaired
  • Memory Impairment
  • Mild Traumatic Brain Injury
  • Mild Cognitive Impairment