Traumatic Brain InjuryNCT04239274
Spectral Correlates of Impulsivity in Patients With Traumatic Brain Injury
A study testing transcranial direct current stimulation and transcranial pulsed current stimulation in people with Traumatic Brain Injury, run by Medical University of South Carolina.
Trial summary
Transcranial electrical stimulation (tES) is a non-invasive form of brain stimulation that has previously been to shown to have therapeutic potential in traumatic brain injury (TBI) patients. Read more about this study
- Who is it for?
- Ages 25 to 70 years
- Conditions the study is for
- Traumatic Brain Injury
- What is being tested?
- transcranial direct current stimulation and transcranial pulsed current stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2020to 1 Jan 2021
- 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 25 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects referred to the PI for management of TBI
- Subject is at least 3 months post-injury at the time of consent
- Ages 25-70
Who cannot join
- Subjects with the inability to consent for themselves
- Subjects with body habitus that does not allow the EEG cap to be properly placed
- Presence of scalp injury or disease
- Allergic reaction to topical lidocaine jelly
- Prior intracranial surgery or skull-fracture over VLPFC
- Presence of hemorrhage on intracranial imaging
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- Prior brain radiotherapy
- Prior history of intracranial tumor, intracranial infection, or cerebrovascular malformation
- Subjects with the inability to see and read from a computer screen
- History of any form of seizures prior to TBI or within 6 months of study participation
- Pregnancy
About this study
Official title: Spectral Correlates of Impulsivity in Patients With Traumatic Brain Injury: A Study of the Effect of Transcranial Electrical Stimulation of the Ventrolateral Prefrontal Cortex on Response Inhibition
Transcranial electrical stimulation (tES) is a non-invasive form of brain stimulation that has previously been to shown to have therapeutic potential in traumatic brain injury (TBI) patients. In this study, the study team will use a brain activity monitor (electroencephalogram, EEG) and a computer-based task to observe the effects of different forms of tES, like transcranial direct current stimulation (tDCS) and transcranial pulsed current stimulation (tPCS), on impulse control and sustained attention in people with TBI. Additionally, the study team will measure how much tDCS and tPCS affect the brain activity of a specific area of the brain associated with impulse control and attention. Problems with response inhibition have been shown to make rehabilitation more difficult for people with TBI. It also reduces social functioning and can also negatively affect job performance, which ultimately lead to a decreased quality of life. A better understanding of the effects of tES in TBI patients could be informative in finding out what its therapeutic potential is for this population.
- Conditions
- Traumatic Brain Injury
- Being tested
- transcranial direct current stimulation, transcranial pulsed current stimulation, Sham-no stimulation
- Medical subject headings
- Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcranial direct current stimulationDevice
Subjects in this arm will receive one session of tDCS for 20 minutes at 2.0 milliamps.
transcranial pulsed current stimulationDevice
Subjects in this arm will receive one session of tPCS for 20 minutes at 2.0 milliamps.
Sham-no stimulationDevice
Subjects in this arm will receive one session of sham for 20 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Transcranial Direct Current Stimulation (tDCS) | Experimental | Not described Receives: Device: transcranial direct current stimulation |
| Transcranial Pulsed Stimulation tPCS | Experimental | Not described Receives: Device: transcranial pulsed current stimulation |
| No Stimulation | Sham comparator | Not described Receives: Device: Sham-no stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average Reaction Time During Stop Signal Task
The Stop Signal Task (SST) is an assessment which requires participants to respond to various stimuli with a specific action and to not respond when a "stop" stimulus is presented.
Measured: Throughout study (1 hour)
EEG power in all frequency bands
They will be fitted with a standard EEG cap consisting of 32 EEG electrodes placed in the 10/20 international system format, a standardized system for EEG electrode placement. Frequency bands will be measured.
Measured: Baseline and immediately post Stimulation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2020
- Study start1 Jan 2020
- Primary completion1 Jan 2021
- Study completion1 Jan 2021
Why it stopped: no participants enrolled due to COVID
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.
- More trials run by Medical University of South CarolinaThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nathan Rowland, Medical University of South Carolina
- Investigators
- Nathan Rowland, MD,PhD, Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04239274
- Sponsor's protocol ID
- 00093356
- Status last verified
- Dec 2021
- First submitted
- 14 Jan 2020
- Last updated
- 4 Jan 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after deidentification may be shared as well as the study protocol, statistical analysis plan, and analytic code.
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spectral Correlates of Impulsivity in Patients With Traumatic Brain Injury: A Study of the Effect of Transcranial Electrical Stimulation of the Ventrolateral Prefrontal Cortex on Response Inhibition
- ClinicalTrials.gov ID
- NCT04239274
- Acronym / sponsor ID
- 00093356
- Conditions
- Traumatic Brain Injury
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: no participants enrolled due to COVID
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 1 Jan 2021 (actual)
- Study completion
- 1 Jan 2021 (actual)
- First posted
- 27 Jan 2020 (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.
Transcranial electrical stimulation (tES) is a non-invasive form of brain stimulation that has previously been to shown to have therapeutic potential in traumatic brain injury (TBI) patients. In this study, the study team will use a brain activity monitor (electroencephalogram, EEG) and a computer-based task to observe the effects of different forms of tES, like transcranial direct current stimulation (tDCS) and transcranial pulsed current stimulation (tPCS), on impulse control and sustained attention in people with TBI. Additionally, the study team will measure how much tDCS and tPCS affect the brain activity of a specific area of the brain associated with impulse control and attention. Problems with response inhibition have been shown to make rehabilitation more difficult for people with TBI. It also reduces social functioning and can also negatively affect job performance, which ultimately lead to a decreased quality of life. A better understanding of the effects of tES in TBI patients could be informative in finding out what its therapeutic potential is for this population.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Transcranial Direct Current Stimulation (tDCS) | Experimental | Device: transcranial direct current stimulation |
| Transcranial Pulsed Stimulation tPCS | Experimental | Device: transcranial pulsed current stimulation |
| No Stimulation | Sham comparator | Device: Sham-no stimulation |
Who may qualify
- Ages
- 25 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subjects referred to the PI for management of TBI
- Subject is at least 3 months post-injury at the time of consent
- Ages 25-70
Key exclusion criteria (11 listed)
- Subjects with the inability to consent for themselves
- Subjects with body habitus that does not allow the EEG cap to be properly placed
- Presence of scalp injury or disease
- Allergic reaction to topical lidocaine jelly
- Prior intracranial surgery or skull-fracture over VLPFC
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 |
|---|---|---|
| transcranial direct current stimulationSubjects in this arm will receive one session of tDCS for 20 minutes at 2.0 milliamps. | Device | Transcranial Direct Current Stimulation (tDCS) |
| transcranial pulsed current stimulationSubjects in this arm will receive one session of tPCS for 20 minutes at 2.0 milliamps. | Device | Transcranial Pulsed Stimulation tPCS |
| Sham-no stimulationSubjects in this arm will receive one session of sham for 20 minutes. | Device | No Stimulation |
Primary outcome
Average Reaction Time During Stop Signal Task
Time frame: Throughout study (1 hour)
The Stop Signal Task (SST) is an assessment which requires participants to respond to various stimuli with a specific action and to not respond when a "stop" stimulus is presented.
EEG power in all frequency bands
Time frame: Baseline and immediately post Stimulation
They will be fitted with a standard EEG cap consisting of 32 EEG electrodes placed in the 10/20 international system format, a standardized system for EEG electrode placement. Frequency bands will be measured.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2022.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after deidentification may be shared as well as the study protocol, statistical analysis plan, and analytic code.
Related trials for Traumatic Brain Injury
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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.
Nathan Rowland, MD,PhD principal investigator
Medical University of South Carolina
Questions about this trial
What is this clinical trial studying?
A study testing transcranial direct current stimulation and transcranial pulsed current stimulation in people with Traumatic Brain Injury, run by Medical University of South Carolina.
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 3 inclusion and 11 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: withdrawn, as of the sponsor's last update on 4 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Average Reaction Time During Stop Signal Task (time frame: Throughout study (1 hour)). The study lists 2 primary outcomes in all. 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 4 Jan 2022.