Traumatic Brain InjuryNCT02613936
Transcranial Direct Current Stimulation for the Treatment of Deficits After Traumatic Brain Injury
A study testing Anodal tDCS and Cognitive training in people with Traumatic Brain Injury and Post Concussive Symptoms, run by University of New Mexico at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Traumatic Brain Injury, Post Concussive Symptoms, Depression
- What is being tested?
- Anodal tDCS and Cognitive training
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2015to Jul 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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)
- 1 out of 4 cognitive symptoms on the Neurobehavioral Symptom Inventory (NSI)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
UNM Center for Brain Recovery and Repair
Albuquerque, New Mexico, 87131
About this study
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.
Read the detailed description
Our long-term goal is to develop safe and effective treatments for symptoms of mild to moderate TBI (mmTBI) that restore patients to higher levels of functioning, decrease disability, and promote brain healing. The objective of this application is to investigate the use of transcranial direct current stimulation (tDCS) to treat symptoms of executive dysfunction and depression in patients with mmTBI. Our central hypotheses are (1) tDCS paired with relevant cognitive training facilitates improves executive function on National Institutes of Health (NIH)-approved neuropsychological measures, (2) tDCS reduces depression scores on NIH Common Data Elements for TBI, (3) that these improvements in emotion and cognition will be detectable up to one year after stimulation, and (4) certain clinical variables will reliably predict response to tDCS. These objectives were formulated based on our clinical experience with Dr. Ronald Yeo (project mentor) characterizing symptomatic patients with mmTBI in the post-acute setting and groundbreaking research led by Dr. Vincent Clark (project mentor) that has demonstrated robust increases in attention and learning with tDCS.
Specific Aim 1: tDCS for executive dysfunction in mmTBI Experiments in this aim will test the hypothesis that in patients with mmTBI, left prefrontal anodal tDCS concurrent with cognitive training for ten consecutive weekdays will result in significantly more improvement in executive function compared to sham stimulation. Patients with cognitive complaints 3 months to 2 years after mmTBI will be recruited from local emergency departments and brain injury clinics. Aim 1.1: tDCS will be paired with computer-based cognitive training tasks of response inhibition, set shifting, and working memory, while executive function will be measured with the NIH Examiner battery before, immediately after, and one month after stimulation. Aim 1.2: Persistence of post-traumatic symptom reduction and quality of life improvement will be assessed with Common Data Elements instruments via telephone interview at 6 months and one year. Aim 1.3: Clinical predictors of tDCS response including injury severity, premorbid intelligence, and post-traumatic symptom burden will be determined with linear mixed-models analysis.
Specific Aim 2: tDCS for depressive symptoms in mmTBI Experiments in this aim will test the hypothesis that left prefrontal anodal tDCS in patients with mmTBI will significantly reduce depressive symptoms compared to sham stimulation. Aim 2.1: Patients will be assessed for symptoms of depression via self-report instruments and clinician-administered scales from NIH Common Data Elements before, immediately after, and one month after the stimulation protocol. Aim 2.2: Persistence of antidepressant benefit will be assessed via telephone interview at 6 months and one year. Aim 2.3: clinical predictors of tDCS response such as injury severity, premorbid intelligence, and symptom burden will be determined.
- Being tested
- Anodal tDCS, Cognitive training
- Keywords
- traumatic brain injury, post concussive symptoms, depression, executive dysfunction, brain stimulation
- Medical subject headings
- Brain Injuries, Traumatic, Post-Concussion Syndrome, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anodal tDCSDevice
Anodal tDCS lowers neuronal membrane potentials, leading to increased probability of depolarization from incoming stimuli.
Cognitive trainingBehavioural
Cognitive training involves solving executive function tasks on a computer.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Cognitive training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2015 (estimated)
- Study startSep 2015
- Primary completionAug 2020
- Study completionJul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of New Mexico
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of General Medical Sciences (NIGMS)
- Responsible party
- Sponsor
- Investigators
- William Shuttleworth, PhD, Principal investigator, UNM Center for Brain Recovery and Repair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02613936
- Sponsor's protocol ID
- UNM HRRC #15-124
- Other IDs
- 1P20GM109089-01A1
- Status last verified
- Oct 2023
- First submitted
- 23 Nov 2015
- Last updated
- 6 Oct 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Individual patient data on task performance may be requested from the researchers after study completion.
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcranial Direct Current Stimulation for the Treatment of Deficits After Traumatic Brain Injury
- ClinicalTrials.gov ID
- NCT02613936
- Acronym / sponsor ID
- UNM HRRC #15-124
- Keywords
- traumatic brain injury, post concussive symptoms, depression, executive dysfunction, brain stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of New MexicoUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of General Medical Sciences (NIGMS)
- Study start
- Sep 2015
- Primary completion
- Aug 2020 (actual)
- Study completion
- Jul 2022 (actual)
- First posted
- 25 Nov 2015 (estimated)
- Results
- Posted 6 Oct 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Our long-term goal is to develop safe and effective treatments for symptoms of mild to moderate TBI (mmTBI) that restore patients to higher levels of functioning, decrease disability, and promote brain healing. The objective of this application is to investigate the use of transcranial direct current stimulation (tDCS) to treat symptoms of executive dysfunction and depression in patients with mmTBI. Our central hypotheses are (1) tDCS paired with relevant cognitive training facilitates improves executive function on National Institutes of Health (NIH)-approved neuropsychological measures, (2) tDCS reduces depression scores on NIH Common Data Elements for TBI, (3) that these improvements in emotion and cognition will be detectable up to one year after stimulation, and (4) certain clinical variables will reliably predict response to tDCS. These objectives were formulated based on our clinical experience with Dr. Ronald Yeo (project mentor) characterizing symptomatic patients with mmTBI in the post-acute setting and groundbreaking research led by Dr. Vincent Clark (project mentor) that has demonstrated robust increases in attention and learning with tDCS.
Specific Aim 1: tDCS for executive dysfunction in mmTBI Experiments in this aim will test the hypothesis that in patients with mmTBI, left prefrontal anodal tDCS concurrent with cognitive training for ten consecutive weekdays will result in significantly more improvement in executive function compared to sham stimulation. Patients with cognitive complaints 3 months to 2 years after mmTBI will be recruited from local emergency departments and brain injury clinics. Aim 1.1: tDCS will be paired with computer-based cognitive training tasks of response inhibition, set shifting, and working memory, while executive function will be measured with the NIH Examiner battery before, immediately after, and one month after stimulation. Aim 1.2: Persistence of post-traumatic symptom reduction and quality of life improvement will be assessed with Common Data Elements instruments via telephone interview at 6 months and one year. Aim 1.3: Clinical predictors of tDCS response including injury severity, premorbid intelligence, and post-traumatic symptom burden will be determined with linear mixed-models analysis.
Specific Aim 2: tDCS for depressive symptoms in mmTBI Experiments in this aim will test the hypothesis that left prefrontal anodal tDCS in patients with mmTBI will significantly reduce depressive symptoms compared to sham stimulation. Aim 2.1: Patients will be assessed for symptoms of depression via self-report instruments and clinician-administered scales from NIH Common Data Elements before, immediately after, and one month after the stimulation protocol. Aim 2.2: Persistence of antidepressant benefit will be assessed via telephone interview at 6 months and one year. Aim 2.3: clinical predictors of tDCS response such as injury severity, premorbid intelligence, and symptom burden will be determined.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active anodal tDCS + cognitive training | Experimental | Device: Anodal tDCS, Behavioral: Cognitive trainingIn this arm, patients with mmTBI will undergo 10 sessions of active tDCS x 30 minutes combined with simultaneous cognitive training on consecutive weekdays. |
| Placebo anodal tDCS + cognitive training | Sham comparator | Behavioral: Cognitive trainingIn this arm, patients with mmTBI will undergo 10 sessions of placebo tDCS x 30 minutes combined with simultaneous cognitive training on consecutive weekdays. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (8 listed)
- 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
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 |
|---|---|---|
| Anodal tDCSAnodal tDCS lowers neuronal membrane potentials, leading to increased probability of depolarization from incoming stimuli. | Device | Active anodal tDCS + cognitive training |
| Cognitive trainingCognitive training involves solving executive function tasks on a computer. | Behavioural | Active anodal tDCS + cognitive training, Placebo anodal tDCS + cognitive training |
Primary outcome
Examiner Score
Time frame: 1 month
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- For interested volunteers please visit this webpage for contact information to enroll.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Individual patient data on task performance may be requested from the researchers after study completion.
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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.
William Shuttleworth, PhD principal investigator
UNM Center for Brain Recovery and Repair
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Anodal tDCS and Cognitive training in people with Traumatic Brain Injury and Post Concussive Symptoms, run by University of New Mexico 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 8 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: finished, as of the sponsor's last update on 6 Oct 2023. 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?
Yes. Results are posted in the registry (first posted 6 Oct 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Examiner Score (time frame: 1 month). 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 6 Oct 2023.