Combined tDCS and Cognitive Training to Reduce Impulsivity in Patients With Traumatic Brain Injury

NCT03844607 | Active Not Recruiting FDA Device

• 1 other identifier: VAM-18-00308
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

Behavioral changes following a traumatic brain injury (TBI) are one of the biggest challenges for patients, as well as their family members and others involved in their recovery. One of the most common behavioral changes following TBI is the emergence of impulsive behavior, which has been associated with destructive, suicidal, and aggressive behavior, and is related to poor rehabilitation program adherence. The primary objective of this study is to investigate the effect of a novel neuroplasticity based intervention that combines cognitive training and transcranial direct current stimulation (tDCS) to reduce impulsivity and to improve outcomes and quality of life for those who have suffered a TBI.

Conditions

Traumatic Brain Injury; Impulsivity

Outcome Measures

Primary Outcomes (1)

• Change in Barratt Impulsiveness Scale (BIS)

  Differences in magnitude of change in BIS scores between active tDCS and sham groups from baseline to follow-up sessions. Higher total score on the BIS indicates higher levels of impulsivity.

  Change between baseline and 1 week follow-up; 1, 2, and 3 months following intervention

Secondary Outcomes (2)

• Change in choice of higher risk option in the Risk Task

  Change between baseline and 1 week follow-up; 1, 2, and 3 months following intervention

• Change in Brain Functional Connectivity as measured by functional magnetic resonance imaging (fMRI)

  Change between baseline and 1 week follow-up

Study Arms (2)

Active tDCS

EXPERIMENTAL

Participants will receive 5 sessions of cognitive training concurrent with transcranial direct current stimulation (anode over left frontal cortex, cathode over right frontal cortex; 2 mAmps for 20 minutes).

Device: Active Transcranial Direct Current Stimulation (tDCS)

Sham tDCS

SHAM COMPARATOR

Participants will receive 5 sessions of cognitive training concurrent with sham tDCS. For sham tDCS, electrodes are placed at the same locations as for active tDCS, but current is ramped up for the initial 30 secs, then immediately ramped back down. This method mimics the initial physical sensation of stimulation, but there is no active current for the remainder of the session.

Device: Sham Transcranial Direct Current Stimulation (tDCS)

Interventions

Active Transcranial Direct Current Stimulation (tDCS) DEVICE

Cognitive training concurrent with 2 mAmps of anodal stimulation applied to the left frontal cortex for 20 minutes.

Active tDCS

Sham Transcranial Direct Current Stimulation (tDCS) DEVICE

Cognitive training concurrent with sham tDCS (30 secs ramp up/ramp down of current at beginning of session).

Sham tDCS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants will be included in the study if they:
• have a clinical history of impulsive behavior, including substance abuse, gambling problems, legal issues such as DUI, violent acts, aggression, history of suicidality, or ADHD as assessed by the patient's clinical provider and/or screen of medical records
• are age 18 or older
• are receiving services from the Minneapolis VA Health Care System
• are stable on any medications for at least 1 week at the baseline visit
• have a diagnosis of mild, moderate, or severe TBI (as defined by VA/DoD Clinical Practice Guidelines criteria)

You may not qualify if:

• Persons will be excluded from this study if they:
• have a significant neurological disorder based on the Principal Investigators judgment that would impact risk
• diagnosed with current active psychosis or mania
• have metallic cranial plates/screws or implanted devices
• have eczema on scalp or other scalp lesions or skin disorders that may become irritated by stimulation
• are pregnant

Sponsors & Collaborators

• Minneapolis Veterans Affairs Medical Center: lead
• Minnesota Office of Higher Education: collaborator
• Center for Veterans Research and Education: collaborator
• The Defense and Veterans Brain Injury Center: collaborator

Study Sites (1)

Minneapolis VA Medical Center

Minneapolis, Minnesota, 55417, United States

Location

MeSH Terms

Conditions

Brain Injuries, Traumatic; Impulsive Behavior

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Scientist

Study Record Dates

• First Submitted: February 13, 2019
• First Posted: February 18, 2019
• Study Start: January 8, 2019
• Primary Completion: March 16, 2023
• Study Completion: January 1, 2025
• Last Updated: March 13, 2024

Record last verified: 2024-03

Locations

US (1)