Transcranial Direct Current Stimulation for the Treatment of Deficits After Traumatic Brain Injury

NCT02613936 | Completed Results DMC

• 2 other identifiers: UNM HRRC #15-1241P20GM109089-01A1
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Patients with mild-moderate traumatic brain injury (TBI) sustained between 3 months and 5 years ago with prolonged postconcussive symptoms will be recruited. On Day 1 of the study they will undergo neuropsychological (NP) testing. They will then undergo 10 days of Left dorsolateral prefrontal (DLPFC) anodal transcranial direct current stimulation (TDCS) (active or sham) combined with cognitive training. On day 10 NP testing will be obtained again. On Day 30, NP testing will be repeated a 3rd time. At 6 months and 1 year, quality of life, depression, and post concussive symptoms will be assessed.

Conditions

Traumatic Brain Injury; Post Concussive Symptoms; Depression; Executive Dysfunction

Keywords

traumatic brain injury; post concussive symptoms; depression; executive dysfunction; brain stimulation

Outcome Measures

Primary Outcomes (1)

• Examiner Score

  The NIH Executive Abilities: Measures and Instruments for Neurobehavioral Evaluation and Research (EXAMINER) assesses executive function in four different domains, creating a composite score from all domains, ranging from -3.0 to 2.0 with higher scores indicating better outcome.

  1 month

Study Arms (2)

Active anodal tDCS + cognitive training

EXPERIMENTAL

In this arm, patients with mmTBI will undergo 10 sessions of active tDCS x 30 minutes combined with simultaneous cognitive training on consecutive weekdays.

Device: Anodal tDCS; Behavioral: Cognitive training

Placebo anodal tDCS + cognitive training

SHAM COMPARATOR

In this arm, patients with mmTBI will undergo 10 sessions of placebo tDCS x 30 minutes combined with simultaneous cognitive training on consecutive weekdays.

Behavioral: Cognitive training

Interventions

Anodal tDCS DEVICE

Anodal tDCS lowers neuronal membrane potentials, leading to increased probability of depolarization from incoming stimuli.

Active anodal tDCS + cognitive training

Cognitive training BEHAVIORAL

Cognitive training involves solving executive function tasks on a computer.

Active anodal tDCS + cognitive training; Placebo anodal tDCS + cognitive training

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• aged 18-55
• TBI with + loss of consciousness (LOC) less than 24 hours
• injured between 3 months and 5 years ago
• Glasgow Coma Score (GCS) between 9 and 15 upon emergency department (ED) admission
• less than 1 week of post-traumatic amnesia (PTA)
• out of 4 cognitive symptoms on the Neurobehavioral Symptom Inventory (NSI)

You may not qualify if:

• history of neurological disease or seizures
• history of psychosis
• history of recent substance dependence (past 2 years)
• any skull defect
• presence of any implanted electrical device
• recent medical instability (within 3 weeks)
• pregnancy
• appointment of a legal representative.

Sponsors & Collaborators

• University of New Mexico: lead
• National Institutes of Health (NIH): collaborator
• National Institute of General Medical Sciences (NIGMS): collaborator

Study Sites (1)

UNM Center for Brain Recovery and Repair

Albuquerque, New Mexico, 87131, United States

Location

Related Links

• For interested volunteers please visit this webpage for contact information to enroll.

MeSH Terms

Conditions

Brain Injuries, Traumatic; Post-Concussion Syndrome; Depression

Interventions

Transcranial Direct Current Stimulation; Cognitive Training

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Brain Concussion; Head Injuries, Closed; Wounds, Nonpenetrating; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques; Neurological Rehabilitation; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Health Services; Health Care Facilities Workforce and Services

Results Point of Contact

• Title: Dr. Davin Quinn
• Organization: University of New Mexico

dquinn@salud.unm.edu

505-272-2223

Study Officials

• William Shuttleworth, PhD

  UNM Center for Brain Recovery and Repair

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 23, 2015
• First Posted: November 25, 2015
• Study Start: September 1, 2015
• Primary Completion: August 1, 2020
• Study Completion: July 1, 2022
• Last Updated: October 6, 2023
• Results First Posted: October 6, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will share

Locations

US (1)