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Behavioural Intervention
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up post-treatment visit and long-term follow-up at 3 and 6 months
Awards & highlights
CONNECT-TBI Trial 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.Check my eligibility
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.See study design
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.
CONNECT-TBI Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I had memory loss for less than a day after my injury.
Select...
I am a veteran or warfighter between 18 and 59 years old.
CONNECT-TBI Trial 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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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.
+1 moreCONNECT-TBI Trial Design
4Treatment groups
Active Control
Placebo Group
Group I: Active rTMS with Attention Process TrainingActive Control2 Interventions
Subjects in this arm will receive active rTMS and then complete the assigned Attention Process Training battery immediately following active rTMS.
Group II: Active HD-tDCS with Attention Process TrainingActive Control2 Interventions
Subjects in this arm will receive active HD-tDCS and complete the assigned Attention Process Training battery during active HD-tDCS.
Group III: Sham rTMS with Attention Process TrainingPlacebo Group2 Interventions
Subjects in this sham arm will not receive any active stimulation and will only complete Attention Process Training immediately following sham rTMS.
Group IV: Sham HD-tDCS with Attention Process TrainingPlacebo Group2 Interventions
Subjects in this sham arm will not receive any active stimulation and will only complete Attention Process Training during sham HD-tDCS.
Find a Location
Who is running the clinical trial?
University of New MexicoLead Sponsor
372 Previous Clinical Trials
3,528,681 Total Patients Enrolled
The Mind Research NetworkOTHER
26 Previous Clinical Trials
2,392 Total Patients Enrolled
New Mexico VA Healthcare SystemFED
6 Previous Clinical Trials
793 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You had an injury 3 months to 5 years ago.You had a Glasgow coma scale (GCS) score that was too low or too high when you were admitted to the emergency department.I had memory loss for less than a day after my injury.You are currently involved in a lawsuit related to traumatic brain injury.You have a history of severe mental illness where you may have lost touch with reality.I was hospitalized within the last three weeks.You have had a problem with drugs or alcohol in the past two years.My gender does not affect my eligibility for this trial.I am a veteran or warfighter between 18 and 59 years old.My mental health medication doses have been stable for 2 months.You had a minor head injury with changes in how your brain works or a loss of consciousness for less than 30 minutes.I have a history of neurological diseases or seizures not caused by immediate trauma.You have had surgery to replace part of your skull.You should not be exposed to strong magnetic fields or MRI scans.I do not have severe hearing loss or blindness that would prevent me from completing cognitive training.You have ongoing problems with memory, thinking, or focus after a head injury, and these problems are measured at a certain level of severity.
Research Study Groups:
This trial has the following groups:- Group 1: Active rTMS with Attention Process Training
- Group 2: Sham rTMS with Attention Process Training
- Group 3: Active HD-tDCS with Attention Process Training
- Group 4: Sham HD-tDCS with Attention Process Training
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any opportunities to participate in this experiment currently?
"According to clinicaltrials.gov, the trial remains open for recruitment as of February 1st 2022; having been initially posted on January 21st 2022."
Answered by AI
Who is eligible to take part in this investigation?
"Applicants wishing to join this study must have brain trauma, be between 18 and 59 years old, and 108 patients will ultimately be accepted."
Answered by AI
What is the current sample size of this experiment?
"Affirmative. Information from clinicaltrials.gov shows that this trial, which was posted on January 21st 2022, is currently recruiting participants. The team needs to enlist 108 patients between two locations."
Answered by AI
Are senior citizens excluded from the scope of this medical research?
"This study has an age limit of eighteen years and below sixty for enrolment eligibility."
Answered by AI
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