Remote Stimulation and Training to Advance Recovery From TBI in Seniors
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65+
SponsorMinneapolis Veterans Affairs Medical Center
About this trial
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? * Is this type of home-based program feasible and acceptable for older adults with TBI?
Researchers will compare two groups: one group will receive active tDCS during cognitive training, and the other group will receive sham (placebo) tDCS during cognitive training.
Participants will:
* Complete computer-based cognitive training exercises (BrainHQ) to practice attention, memory, and decision-making. * Receive either active or sham tDCS during training sessions. * Complete assessments before and after the program to measure changes in thinking and daily functioning.
Eligibility criteria
Qualifiers
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 opinion of the principal investigator.
Disqualifiers
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 pose a significant risk to the participant, (b) raises the possibility that the participant is unlikely to successfully complete all 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 near the stimulation site, brain surgery, stroke with current sequalae, epilepsy, multiple sclerosis, Huntington's Disease, ALS, ataxia, aphasia, Alzheimer's Disease, and dementia.
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.
Trial design
Treatments tested in this trial
- Active tDCS and Cognitive Training Intervention
- Sham tDCS and Cognitive Training Intervention
Treatment groups
40 Participants
are divided into 2 treatment groupsSponsors and collaborators
Minneapolis Veterans Affairs Medical Center
Lead sponsor
Center for Veterans Research and Education
Collaborator
Source ClinicalTrials.gov