Traumatic Brain InjuryNCT03844607
Combined tDCS and Cognitive Training to Reduce Impulsivity in Patients With Traumatic Brain Injury
A study testing Active Transcranial Direct Current Stimulation (tDCS) in people with Traumatic Brain Injury and Impulsivity, run by Minneapolis Veterans Affairs Medical Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Traumatic Brain Injury, Impulsivity
- What is being tested?
- Active Transcranial Direct Current Stimulation (tDCS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jan 2019to 1 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Minneapolis VA Medical Center
Minneapolis, Minnesota, 55417
About this study
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.
Read the detailed 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.
- Conditions
- Traumatic Brain Injury, Impulsivity
- Being tested
- Active Transcranial Direct Current Stimulation (tDCS), Sham Transcranial Direct Current Stimulation (tDCS)
- Medical subject headings
- Brain Injuries, Traumatic, Impulsive Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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).
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. Receives: Device: Sham Transcranial Direct Current Stimulation (tDCS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 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)
Compare magnitude of change in frontal-striatal functional connectivity between active tDCS and sham groups from baseline to following the 5 sessions of intervention.
Measured: Change between baseline and 1 week follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2019
- Study start8 Jan 2019
- Primary completion16 Mar 2023
- Study completion1 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Minneapolis Veterans Affairs Medical Center
- Sponsor type
- US federal agency
- Collaborators
- Minnesota Office of Higher Education, Center for Veterans Research and Education, The Defense and Veterans Brain Injury Center
- Responsible party
- Principal investigator, Casey Gilmore, PhD, Minneapolis Veterans Affairs Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03844607
- Sponsor's protocol ID
- VAM-18-00308
- Status last verified
- Mar 2024
- First submitted
- 13 Feb 2019
- Last updated
- 13 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined tDCS and Cognitive Training to Reduce Impulsivity in Patients With Traumatic Brain Injury
- ClinicalTrials.gov ID
- NCT03844607
- Acronym / sponsor ID
- VAM-18-00308
- Conditions
- Traumatic Brain Injury, Impulsivity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Minneapolis Veterans Affairs Medical CenterUS federal agency
- Collaborators
- Minnesota Office of Higher Education, Center for Veterans Research and Education, The Defense and Veterans Brain Injury Center
- Study start
- 8 Jan 2019 (actual)
- Primary completion
- 16 Mar 2023 (actual)
- Study completion
- 1 Jan 2025 (estimated)
- First posted
- 18 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active tDCS | Experimental | Device: Active Transcranial Direct Current Stimulation (tDCS)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). |
| Sham tDCS | Sham comparator | Device: Sham Transcranial Direct Current Stimulation (tDCS)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Active tDCS |
| Sham Transcranial Direct Current Stimulation (tDCS)Cognitive training concurrent with sham tDCS (30 secs ramp up/ramp down of current at beginning of session). | Device | Sham tDCS |
Primary outcome
Change in Barratt Impulsiveness Scale (BIS)
Time frame: Change between baseline and 1 week follow-up; 1, 2, and 3 months following intervention
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.
2 secondary outcomes
Change in choice of higher risk option in the Risk Task
Time frame: 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)
Time frame: Change between baseline and 1 week follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active Transcranial Direct Current Stimulation (tDCS) in people with Traumatic Brain Injury and Impulsivity, run by Minneapolis Veterans Affairs Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Barratt Impulsiveness Scale (BIS) (time frame: Change between baseline and 1 week follow-up; 1, 2, and 3 months following intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2024.