Targeting Neuroplasticity for Persistent Post-Concussive Cognitive Symptoms

University of Minnesota30 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Persistent Post Concussion Syndrome Mild Traumatic Brain Injury

Interventions

Active tDCSDEVICE

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 tDCSDEVICE

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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)

Locations (1)

University of Minnesota

Minneapolis, Minnesota, United States

RECRUITING

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

Central Contacts

Melanie Stimac

CONTACT

612-301-2549 stima011@umn.edu

Data from ClinicalTrials.gov

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