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Spectral Correlates of Impulsivity in Patients With Traumatic Brain Injury

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

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04239274
Enrollment
0
Registered
2020-01-27
Start date
2020-01-01
Completion date
2021-01-01
Last updated
2022-01-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Traumatic Brain Injury

Brief 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.

Interventions

DEVICEtranscranial direct current stimulation

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

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.

Sponsors

Medical University of South Carolina
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
25 Years to 70 Years
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

* 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

Design outcomes

Primary

MeasureTime frameDescription
Average Reaction Time During Stop Signal TaskThroughout 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 bandsBaseline and immediately post StimulationThey 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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026