Targeting Neuroplasticity for Persistent Post-Concussive Cognitive Symptoms

ConditionsPersistent Post Concussion Syndrome Mild Traumatic Brain Injury

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-65

SponsorUniversity of Minnesota

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

Active tDCS
Device
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.
Sham tDCS
Device
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.

Treatment groups

30 Participants

are divided into 2 treatment groups

Group A: Active tDCS + Cognitive TrainingActive comparator 1 intervention

Group B: Sham tDCS + Cognitive TrainingPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

Efficacy of active tDCS combined with cognitive training compared to sham tDCS combined with cognitive training for improving executive function in individuals with PPCS

Using score on Penn Cognitive Battery

Time frame

Week 4

Secondary outcomes

Effects of active versus sham tDCS combined with cognitive training on self-reported affect, stress, cognition, and objectively measured sleep and activity levels

Ecological Momentary Assessment Survey score

Time frame

Week 4

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Minnesota

Lead sponsor

Source ClinicalTrials.gov

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