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New treatment option for Traumatic Brain Injury
Official title Remote Stimulation and Training to Advance Recovery From TBI in Seniors
ClinicalTrials.gov ID: NCT07332299
What this study is testing
What is Active tDCS and Cognitive Training Intervention?
Active tDCS and Cognitive Training Intervention is an investigational medicine, given as an once-daily, being studied as a potential treatment for traumatic brain injury.
Also referred to as tDCS.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The goal of this clinical trial is to learn if combining brain stimulation with cognitive training can improve thinking skills in older adults who have had a traumatic brain injury (TBI). The main questions are: Does transcranial direct current stimulation (tDCS) make cognitive training more effective for improving attention, memory, and decision-making?
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 65 and older
You may be able to join if
- Veterans age 65 and older.
- History of mild TBI (as defined by the DOD/VA criteria used in conjunction with the OSU TBI-ID) sustained at least 3 months prior to enrollment.
- Self-reported or medically documented attention and/or concentration difficulties.
- Stable dose of all prescription and non-prescription medications that may impact cognition or brain chemistry (except for PRN medication) for at...
- Capable and willing to provide voluntary informed consent, in the medical opinion of the principal investigator.
You likely can't join if
- Presence of a medical, psychiatric, physical or non-physical disease, disorder, condition, injury, disability or pre-existent history such that study...
- Moderate to severe cognitive impairment with MoCA score (assessed upon enrollment) less than 15.
- Prior treatment with ECT or neuromodulation in the last 12 months.
- Current severe alcohol or substance use disorder with evidence of withdrawal or tolerance within the past 6 months, based on psychiatric history...
- Psychosis or mania within 30 days of enrollment, as determined by the principal investigator, based on psychiatric history and/or a review of...
- Contraindications for tDCS (e.g., metallic cranial plates/screws or implanted device, eczema or skin lesions on scalp near electrode site, etc.).
See the full eligibility criteria
- Veterans age 65 and older.
- History of mild TBI (as defined by the DOD/VA criteria used in conjunction with the OSU TBI-ID) sustained at least 3 months prior to enrollment.
- Self-reported or medically documented attention and/or concentration difficulties.
- Stable dose of all prescription and non-prescription medications that may impact cognition or brain chemistry (except for PRN medication) for at least 3 weeks prior to the baseline session (Visit 1), in the medical...
- Capable and willing to provide voluntary informed consent, in the medical opinion of the principal investigator.
- 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 principal investigator: (a) may...
- Moderate to severe cognitive impairment with MoCA score (assessed upon enrollment) less than 15.
- Prior treatment with ECT or neuromodulation in the last 12 months.
- Current severe alcohol or substance use disorder with evidence of withdrawal or tolerance within the past 6 months, based on psychiatric history and/or a review of available medical records.
- Psychosis or mania within 30 days of enrollment, as determined by the principal investigator, based on psychiatric history and/or a review of available medical records.
- Contraindications for tDCS (e.g., metallic cranial plates/screws or implanted device, eczema or skin lesions on scalp near electrode site, etc.).
- No or limited internet connection in their home.
The study team makes the final eligibility decision.
Where it's taking place
- Minneapolis, Minnesota, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Minneapolis, Minnesota, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.