Combined tDCS and Cognitive Training to Reduce Impulsivity in Patients With Traumatic Brain Injury
NCT03844607 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 33
Last updated 2024-03-13
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
Interventions
- 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.
- DEVICE
-
Sham Transcranial Direct Current Stimulation (tDCS)
Cognitive training concurrent with sham tDCS (30 secs ramp up/ramp down of current at beginning of session).
Sponsors & Collaborators
-
Minnesota Office of Higher Education
collaborator OTHER_GOV -
Center for Veterans Research and Education
collaborator OTHER -
The Defense and Veterans Brain Injury Center
collaborator FED -
Minneapolis Veterans Affairs Medical Center
lead FED
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2019-01-08
- Primary Completion
- 2023-03-16
- Completion
- 2025-01-01
- FDA Device
- Yes
Countries
- United States
Study Locations
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