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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Active tDCS and Cognitive Training Intervention
Combination productForty-five minutes of cognitive training concurrent with 2 mAmps of anodal stimulation applied to the left frontal cortex for the first 20 minutes of the session.
Sham tDCS and Cognitive Training Intervention
Combination productForty-five minutes of cognitive training concurrent with sham tDCS (30 secs ramp up/ramp down of current at beginning and end of session).
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Active tDCS with cognitive trainingExperimental treatment 1 intervention
Group B: Sham tDCS with cognitive trainingSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) Total Scale Score
The RBANS is a commonly-used, psychometrically-sound measure of cognitive function across the lifespan. The primary outcome measure is the Total Scale score, which is a standard score (mean 100, SD 15) across five cognitive domains (Immediate/Delayed Memory, Visuospatial, Attention, Language).
Time frame
Baseline, 1-week post, & 6-weeks post intervention2
Electroencephalogram (EEG) - Resting State Theta Band Functional Connectivity
Resting State EEG will be collected to assess neural dynamics or functional connectivity and spectral power of delta,theta, alpha, beta, and gamma frequency bands. The primary outcome measure will be change in prefrontal-parietal functional connectivity in the theta frequency band.
Time frame
Baseline, 1-week post, & 6-weeks post interventionSecondary outcomes
1
Neurobehavioral Symptom Inventory (NSI) Total Score
A 22-item measure that assesses post-concussive symptoms for those with a TBI.
Time frame
Baseline, 1-week post, & 6-weeks post intervention2
Insomnia Severity Index (ISI) Total Score
A 7-item measure of the severity of nighttime and daytime components of insomnia.
Time frame
Baseline, 1-week post, & 6-weeks post intervention3
Patient Health Questionnaire-8 (PHQ-8) Total Score
An 8-item measure of depressive symptoms.
Time frame
Baseline, 1-week post, & 6-weeks post intervention4
Groton Maze Learning Task (GMLT) Completion Time
A computer cognitive test of spatial working memory and error monitoring.
Time frame
Baseline, 1-week post, & 6-weeks post interventionSponsors and contacts
Click on the lead sponsor to view all of their trials.
Minneapolis Veterans Affairs Medical Center
Lead sponsor
Center for Veterans Research and Education
Collaborator
Source ClinicalTrials.gov