Neuromodulation + Cognitive Training for Traumatic Brain Injury (CONNECT-TBI Trial)

N/A

Recruiting

Led By Davin k Quinn, MD, FACLP

Research Sponsored by University of New Mexico

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Experienced less than 24 hours of post-traumatic amnesia (PTA)

Veterans and Warfighters aged 18-59

Must not have

Recent medical hospitalization (within three weeks)

Prior history of other neurological disease or any history of seizures beyond immediate post-traumatic seizure

Timeline

Screening 3 weeks

Treatment Varies

Follow Up post-treatment visit and long-term follow-up at 3 and 6 months

Summary

This trial is testing if a certain combination of treatments can help improve cognitive functioning for people with complex mTBI and PPCS.

Who is the study for?

This trial is for Veterans aged 18-59 who've had a mild traumatic brain injury (TBI) with specific cognitive symptoms, and have been stable on any psychotropic meds for 2 months. They must not be pregnant, involved in TBI litigation, or have certain medical conditions like psychosis or recent substance dependence.

What is being tested?

The CONNECT-TBI Trial tests whether Attention Process Training combined with either rTMS (magnetic stimulation), HD-tDCS (electrical brain stimulation), or sham treatment improves cognitive function in those with complex mTBI. Participants will undergo extensive testing before and after the treatments to measure effectiveness.

What are the potential side effects?

Potential side effects from rTMS may include headaches, scalp discomfort at the site of stimulation, lightheadedness, and rare risk of seizure. HD-tDCS might cause skin irritation under the electrodes used for stimulation as well as tingling sensations during application.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I had memory loss for less than a day after my injury.

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I am a veteran or warfighter between 18 and 59 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I was hospitalized within the last three weeks.

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I have a history of neurological diseases or seizures not caused by immediate trauma.

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I do not have severe hearing loss or blindness that would prevent me from completing cognitive training.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ post-treatment visit and long-term follow-up at 3 and 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~post-treatment visit and long-term follow-up at 3 and 6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and post-treatment visit and long-term follow-up at 3 and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Primary cognitive outcome: Change from baseline in objective cognitive control as measured by accuracy on the Multi-modal Working Memory N-back task (MMWM) to post-treatment Visit.

Primary functional outcome: Change from post-treatment visit in overall quality of life as measured by the PGIC at long-term follow-up at 3 and 6 months.

Primary imaging outcome: Change (decrease) in CCN activity from Baseline Visit to Post-treatment Visit as measured by the BOLD signal during the MMWM task performance.

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