Mild Traumatic Brain Injury, Persistent Post Concussion Syndrome
Conditions
Brief summary
This project investigates an innovative combination of non-invasive neuromodulation (transcranial direct current stimulation - tDCS) and cognitive training as a novel treatment approach aimed at improving function in individuals suffering from persistent post-concussive syndrome (PPCS) following mild traumatic brain injury (mTBI).
Interventions
DEVICEActive tDCS
All participants will receive 10 sessions of cognitive training focused on executive functions, delivered over approximately 3 weeks. Cognitive training will be completed on a lab provided computer using PositScience BrainHQ or TaskFlow software. Concurrently, during each training session, participants will receive either active or sham tDCS. Stimulation will be delivered via saline-soaked sponge electrodes using the Soterix 1x1 miniCT TES device. The anode (active electrode) will be placed over the L-DLPFC (approximated by EEG coordinate F3) and the cathode (reference electrode) over the contralateral supraorbital area (Fp2). The active tDCS group will receive 2mA constant current for 20 minutes.
DEVICESham tDCS
All participants will receive 10 sessions of cognitive training focused on executive functions, delivered over approximately 3 weeks. Cognitive training will be completed on a lab provided computer using PositScience BrainHQ or TaskFlow software. Concurrently, during each training session, participants will receive either active or sham tDCS. Stimulation will be delivered via saline-soaked sponge electrodes using the Soterix 1x1 miniCT TES device. The anode (active electrode) will be placed over the L-DLPFC (approximated by EEG coordinate F3) and the cathode (reference electrode) over the contralateral supraorbital area (Fp2). The sham tDCS group will receive a brief ramp up and ramp down of current at the beginning and end of the 20 minutes to mimic the sensation of active stimulation.
Sponsors
University of Minnesota
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
double-blind, randomized, sham-controlled clinical trial
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Age 18-65 * Has sustained a single mTBI 3-12 months prior to enrollment * Meets criteria for PPCS (assessed using the CP Screen) * Has reliable access to a smartphone
Exclusion criteria
* Inability to provide informed consent or complete study procedures * History of moderate/severe TBI * Significant neurological or psychiatric disorders (other than PPCS-related symptoms like mild depression/anxiety) * Substance dependence within the last six months * Contraindications to tDCS (e.g., implanted metal, skin lesions on scalp)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy of active tDCS combined with cognitive training compared to sham tDCS combined with cognitive training for improving executive function in individuals with PPCS | Week 4 | Using score on Penn Cognitive Battery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Effects of active versus sham tDCS combined with cognitive training on self-reported affect, stress, cognition, and objectively measured sleep and activity levels | Week 4 | Ecological Momentary Assessment Survey score |
Countries
United States
Contacts
CONTACTMelanie Stimac
PRINCIPAL_INVESTIGATORJazmin Camchong, PhD
University of Minnesota
Outcome results
None listed