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Behavioural Intervention

Active tDCS + Cognitive Training for Mild TBI in Active Duty Service Members

N/A
Recruiting
Led By Lars D Hungerford, PhD
Research Sponsored by United States Naval Medical Center, San Diego
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from 1 week post-intervention isi at 6 weeks after the intervention.
Awards & highlights

Study Summary

This trial will test if a new brain stimulation technique, transcranial direct current stimulation (tDCS), can help improve attention and working memory in military service members with a history of mild traumatic brain injury (TBI).

Eligible Conditions
  • Concussion
  • Neurocognitive Disorder
  • Mild Cognitive Impairment
  • Traumatic Brain Injury
  • Attention Deficit Hyperactivity Disorder (ADHD)
  • Attention Deficit Disorder
  • Memory Loss

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~immediately after the intervention.
This trial's timeline: 3 weeks for screening, Varies for treatment, and immediately after the intervention. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Electroencephalogram (EEG)
Magnetic Resonance Imaging (MRI) w/out contrast (optional)
Neurobehavioral Symptom Inventory (NSI)
+2 more
Secondary outcome measures
BrainHQ Task Load Index (TLX)
Fusion Task
Insomnia Severity Index (ISI)
+2 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Active tDCSExperimental Treatment1 Intervention
Based on previous studies targeting working memory, focality of current delivery, and comfort and tolerance levels, (Paulo S. Boggio et al., 2006; Hill et al., 2016; Hoy et al., 2013; Teo, Hoy, Daskalakis, & Fitzgerald, 2011), we will use a 2 mA current administered via two circular carbon rubber core electrodes in saline-soaked surface sponges (25 cm2), placed in a neoprene headcap with marked locations based on the 10-10 EEG system. The anodal stimulating electrode will be at location F3, over left dorsolateral prefrontal cortex (DLPFC) and the cathodal electrode at location F4, over right DLPFC. Two reference electrodes, CMS and DRL, will be attached to the EarClip and applied to the earlobe with conductive gel. Before each training session, the impedance of the electrodes will be checked and verified to be ≤15 KOhm. Additionally, the stimulation will be terminated if the impedance of the electrodes is > 20 KOhm. The current and impedance will be recorded for every session.
Group II: Sham tDCSPlacebo Group1 Intervention
For sham stimulation, the electrodes will be placed at the same positions as for active stimulation (F3 and F4). After an initial ramp-up period of 30 seconds, stimulation fades out over a period of 30 seconds. Additionally, at the end of the sham stimulation period, stimulation will fade in over a period of 30 seconds and then end with a final 30 second ramp-down period. Participants will feel the initial itching sensation associated with tDCS and experience the ramp-down period at the end of the sham stimulation period but will receive no active current during the rest of the sham stimulation period. This method of sham stimulation has been shown to be reliable (Gandiga et al., 2006). Before each training session, the impedance of the electrodes will be checked and verified to be ≤15 KOhm. Additionally, the stimulation will be terminated if the impedance of the electrodes is > 20 KOhm. The current and impedance will be recorded for every session.

Find a Location

Who is running the clinical trial?

United States Naval Medical Center, San DiegoLead Sponsor
102 Previous Clinical Trials
22,656 Total Patients Enrolled
The Defense and Veterans Brain Injury CenterFED
19 Previous Clinical Trials
2,661 Total Patients Enrolled
Lars D Hungerford, PhDPrincipal InvestigatorUnited States Naval Medical Center, San Diego

Media Library

Cognitive Training Intervention (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT04925453 — N/A
Concussion Research Study Groups: Sham tDCS, Active tDCS
Concussion Clinical Trial 2023: Cognitive Training Intervention Highlights & Side Effects. Trial Name: NCT04925453 — N/A
Cognitive Training Intervention (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04925453 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are participants still able to join this research endeavor?

"Affirmative, the information present on clinicaltrials.gov specifies that this medical trial is currently recruiting participants. This endeavor was first revealed on January 19th 2021 and has recently been updated as of September 26th 2022. The research necessitates 60 individuals to be recruited from one site."

Answered by AI

What is the pool of participants for this experiment?

"Affirmative, clinicaltrials.gov illustrates that this experiment is actively recruiting participants. The original posting date of the trial was January 19th 2021 and a subsequent edit occurred on September 26th 2022. Altogether 60 people are needed to be enrolled at 1 site."

Answered by AI

What type of participant is best suited for this clinical investigation?

"Patients who have experienced a brain concussion and are between 18 to 55 years old can qualify for this clinical trial. Approximately 60 individuals will be admitted into the study."

Answered by AI

Is this particular medical research recruiting individuals above the age of eighty?

"This trial requires applicants to be within the 18-55 age range. Conversely, 191 trials are aimed at minors and 1239 studies target seniors."

Answered by AI

What objectives does this experiment seek to accomplish?

"This clinical trial will be evaluated by assessing Change from Baseline MRI at 1 week post-intervention and Symbol Digit Modalities Test (SDMT) as primary outcomes. Secondary analyses include Fusion Task, which is a multi-modal assessment of brain function incorporating EEG measurements such as functional connectivity, mean ERP amplitude, delta-, theta-, alpha-, beta-, and gamma-frequency bands' power; saccadic response time latency & consistency, manual response time latency & consistencey, plus 1-back total score. Also taken into consideration are Insomnia Severity Index (ISI), measuring insomnia severity on an 5 point"

Answered by AI

Who else is applying?

What site did they apply to?
Naval Medical Center San Diego
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
1

Why did patients apply to this trial?

I am feeling like I want to be a part of something where I can relate and understand and apply things I cannot find answers to .
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
tDCS and Cognitive Training in Active Duty Service Members With Mild TBI: A Pilot Study
Lars Hungerford 2021. "tDCS and Cognitive Training in Active Duty Service Members With Mild TBI: A Pilot Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04925453.
~14 spots leftby Apr 2025
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