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Spectral Correlates of Impulsivity in Patients With Traumatic Brain Injury

Medical University of South Carolina (MUSC) logo

Medical University of South Carolina (MUSC)

Status

Withdrawn

Conditions

Traumatic Brain Injury

Treatments

Device: transcranial direct current stimulation
Device: Sham-no stimulation
Device: transcranial pulsed current stimulation

Study type

Interventional

Funder types

Other

Identifiers

NCT04239274
00093356

Details and patient eligibility

About

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.

Sex

All

Ages

25 to 70 years old

Volunteers

No Healthy Volunteers

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

  • 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

0 participants in 3 patient groups

Transcranial Direct Current Stimulation (tDCS)
Experimental group
Treatment:
Device: transcranial direct current stimulation
Transcranial Pulsed Stimulation tPCS
Experimental group
Treatment:
Device: transcranial pulsed current stimulation
No Stimulation
Sham Comparator group
Treatment:
Device: Sham-no stimulation

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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