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

Traumatic Brain Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03844607
• Other study ID #: VAM-18-00308
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 8, 2019
• Est. completion date: January 1, 2025

Study information

• Verified date: March 2024
• Source: Minneapolis Veterans Affairs Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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 approach utilizing transcranial direct current stimulation (tDCS) to alter brain neuroplasticity combined with cognitive training tasks selected to functionally target cognition and brain circuits that are impaired in those TBI patients with impulsive behavior.

This double-blind, randomized, placebo (sham) controlled study will recruit 30 Veterans with a history of mild, moderate or severe TBI, who exhibit a variety of impulsive behaviors. Participants will be randomly assigned to receive either active or sham tDCS, both paired with cognitive training tasks, once a day for five days. Additionally, participants will attend three follow up visits at 1, 2, and 3 months after the course of intervention visits is completed. Functional magnetic resonance imaging (fMRI) will be collected before and after intervention, to measure brain activity changes across time depending on intervention type.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 33
• Est. completion date: January 1, 2025
• Est. primary completion date: March 16, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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)

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Impulsive Behavior
• Impulsivity
• Traumatic Brain Injury
• Wounds and Injuries

Intervention

Device:
• Active Transcranial Direct Current Stimulation (tDCS)
Cognitive training concurrent with 2 mAmps of anodal stimulation applied to the left frontal cortex for 20 minutes.
• Sham Transcranial Direct Current Stimulation (tDCS)
Cognitive training concurrent with sham tDCS (30 secs ramp up/ramp down of current at beginning of session).

Locations

Country	Name	City	State
United States	Minneapolis VA Medical Center	Minneapolis	Minnesota

Sponsors (4)

Lead Sponsor	Collaborator
Minneapolis Veterans Affairs Medical Center	Center for Veterans Research and Education, Minnesota Office of Higher Education, The Defense and Veterans Brain Injury Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in choice of higher risk option in the Risk Task	Differences in magnitude of change in choice of higher risk option during the Risk Task between active tDCS and sham groups from baseline to follow-up sessions. Greater choice of higher risk options in the Risk Task indicates higher levels of risk-taking and impulsivity.	Change between baseline and 1 week follow-up; 1, 2, and 3 months following intervention
Secondary	Change in Brain Functional Connectivity as measured by functional magnetic resonance imaging (fMRI)	Compare magnitude of change in frontal-striatal functional connectivity between active tDCS and sham groups from baseline to following the 5 sessions of intervention.	Change between baseline and 1 week follow-up