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WithdrawnNCT04239274Updated Jan 4, 2022

Spectral Correlates of Impulsivity in Patients With Traumatic Brain Injury

An interventional study of transcranial direct current stimulation and transcranial pulsed current stimulation in Traumatic Brain Injury, sponsored by Medical University of South Carolina. Withdrawn. Open to participants aged 25 Years to 70 Years. Per ClinicalTrials.gov, last updated 2022-01-04.

Sponsored by Medical University of South Carolina · Not applicable, Interventional, and Treatment

Why this study was withdrawn
no participants enrolled due to COVID
Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
25 Years to 70 Years
Sex
All
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Study 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. 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.

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Conditions studied

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In context

Brain Injuries

2,113 studies on the registry are indexed under Brain Injuries; 385 are open to participants now.

Browse Brain Injuries studies →

Lead sponsor

Medical University of South Carolina is the lead sponsor of 852 studies on the registry; 165 are open to participants now.

Of its 128 completed or terminated interventional studies of FDA-regulated products, 101 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
25 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
  • 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
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    Transcranial Direct Current Stimulation (tDCS)

    Device: transcranial direct current stimulation

  • Experimental
    Transcranial Pulsed Stimulation tPCS

    Device: transcranial pulsed current stimulation

  • Sham comparator
    No Stimulation

    Device: Sham-no stimulation

Interventions

  • Devicetranscranial direct current stimulation

    Subjects in this arm will receive one session of tDCS for 20 minutes at 2.0 milliamps.

  • Devicetranscranial pulsed current stimulation

    Subjects in this arm will receive one session of tPCS for 20 minutes at 2.0 milliamps.

  • DeviceSham-no stimulation

    Subjects in this arm will receive one session of sham for 20 minutes.

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: Throughout study (1 hour)

  2. 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.

    Time frame: Baseline and immediately post Stimulation

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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: 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.

Supporting information: Study protocol, Sap, Analytic code

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 4, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04239274
Lead sponsor
Medical University of South Carolina
Responsible party
Nathan Rowland (Assistant Professor, Medical University of South Carolina) — Principal investigator
First posted
Jan 27, 2020
Start date
Jan 1, 2020
Primary completion
Jan 1, 2021
Completion
Jan 1, 2021
Last update
Jan 4, 2022

Study contacts

Nathan Rowland, MD,PhD
principal investigator · Medical University of South Carolina

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Dec 2021. You cannot join it, but the record below documents what was studied.

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