RECRUITING

Remotely Supervised tDCS+ for Complex Attention in mTBI (Cognetric)

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Conditions

Brain ConcussionBrain TraumaAttention Concentration DifficultyBrain InjuriesBrain Injuries, TraumaticNeurocognitive DysfunctionAttention ImpairedMemory ImpairmentMild Traumatic Brain InjuryMild Cognitive ImpairmentPost Concussive SymptomsMilitary HealthBrain StimulationCognitive TrainingCognitive RehabilitationTelehealthNeuromodulation

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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 mTBI using a brain stimulation technique called "Remotely Supervised Transcranial Direct Current Stimulation combined with Cognitive Training" (RS-tDCS+) which has shown promise for improving complex attention in both healthy and clinical populations. RS-tDCS+ is a home-based, low-risk, non-invasive technique that is designed to boost cognitive training by enhancing learning and the brain's ability to reorganize connections. This study will evaluate RS-tDCS+ for improving complex attention in Active Duty Service Members (ADSM) and Veterans with a history of mTBI. Different tests of complex attention and symptom questionnaires will be used to determine the effects of real versus sham (placebo) RS-tDCS+. Second, the investigators will investigate electrical and connectivity changes in the brain associated with RS-tDCS+ using electroencephalogram (EEG) and magnetic resonance imaging (MRI). Third, the investigators will investigate the lasting effects of any observed changes by evaluating participants at 1 and 6 weeks post-treatment. Lastly, the investigators will explore the impact of individual differences (e.g., PTSD, depression, sleep quality, time since injury, baseline impairment, age, sex, ADSM versus Veteran) on treatment outcome.

Official Title

Remotely Supervised tDCS Combined With Cognitive Training to Improve Complex Attention in Active Duty Service Members and Veterans With Mild TBI

Quick Facts

Study Start:2024-07-25
Study Completion:2028-09-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06413173

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 60 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Active-Duty Service Members.
  2. 2. Ages 18 to 60.
  3. 3. All genders.
  4. 4. All racial and ethnic groups.
  5. 5. History of mild TBI (as defined by the DOD/VA criteria used in conjunction with the OSU TBI-ID) sustained at least 3 months and no more than 10 years prior to enrollment.
  6. 6. Self-reported attention and/or concentration difficulties.
  7. 7. At least one cognitive symptom reported on the Neurobehavioral Symptom Inventory (NSI) cognitive subscale.
  1. 1. Presence of a medical, psychiatric, physical or non-physical disease, disorder, condition, injury, disability or pre-existent history such that study participation, in the opinion of the PI: (a) may pose a significant risk to the participant; (b) raises the possibility that the participant is unlikely to successfully complete all of the requirements of the study according to the study protocol; or (c) might adversely impact the integrity of the data or the validity of the study results. Specific conditions include (but are not limited to) a history of: brain tumor, epilepsy, cerebral vascular accident (CVA), Schizophrenia, Bipolar Disorder, and Mania.
  2. 2. History of prior treatment with ECT or neuromodulation in the last 12 months.
  3. 3. Current, diagnosed substance dependence.
  4. 4. Newly prescribed medication within the previous 3 weeks.
  5. 5. Diagnosis of intellectual disability or pervasive developmental disorder (i.e., premorbid IQ less than or equal to 70).
  6. 6. 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 judgment, would impact risk.
  7. 7. Psychosis or mania within 30 days of enrollment, as determined by the PI, based on a psychiatric history and examination and/or a review of available medical records
  8. 8. Contraindications for tDCS (e.g., metallic cranial plates/screws or implanted device, eczema or skin lesions on scalp)
  9. 9. A positive pregnancy report.

Contacts and Locations

Study Contact

Lars D Hungerford, PhD
CONTACT
619.532.5715
lars.d.hungerford.ctr@health.mil
Sean M Molnar, M.A.
CONTACT
424.341.8860
sean.m.molnar2.ctr@health.mil

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
Minneapolis VA Health Case System
Minneapolis, Minnesota, 55417
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 Date2024-07-25
Study Completion Date2028-09-30

Study Record Updates

Study Start Date2024-07-25
Study Completion Date2028-09-30

Terms related to this study

Keywords Provided by Researchers

  • Military Health
  • Brain Stimulation
  • Cognitive Training
  • Cognitive Rehabilitation
  • Telehealth
  • Neuromodulation

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
  • Post Concussive Symptoms