tDCS and Urge in BFRBs
Evaluating the Impact of Transcranial Direct Current Stimulation on Urge in Body-Focused Repetitive Behaviors
1 other identifier
interventional
55
1 country
1
Brief Summary
The goal of this study is to find out if brain stimulation can help people stop skin-picking or nail-biting. The study wants to answer two main questions:
- Talk about their skin-picking, nail-biting, and other mental health concerns
- Be placed in situations that make them want to pick or bite
- Rate how strong their urges are before and after brain stimulation Researchers will compare real brain stimulation to a placebo (a fake version that looks the same but has no effect) to see if the real stimulation works to reduce skin-picking and nail-biting urges and behaviors.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jul 2025
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 23, 2025
CompletedFirst Posted
Study publicly available on registry
June 13, 2025
CompletedStudy Start
First participant enrolled
July 8, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2026
CompletedJuly 23, 2025
July 1, 2025
10 months
May 23, 2025
July 22, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Change in subjective urge
Individuals will rate their urge to pick using a scale (1-10) with a higher score meaning greater urge. They will rate their urge three times in a row, at two different time-points.
baseline and post intervention, approximately 90 minutes
Change in subjective distress
Individuals will rate their distress using a scale (1-10) with a higher score meaning greater distress. They will rate their distress three times in a row, at two different time-points.
baseline and post intervention, approximately 90 minutes
Change in picking or biting behavioral frequency
Picking or biting behaviors will be assessed via two 6-minute blocks of visual observation, before and after tDCS. The frequency of the behaviors observed will be collected in each block. Change in total frequency between blocks will be calculated.
baseline and post intervention (approximately 90 minutes)
Change in picking or biting behaviors duration
Picking or biting behaviors will be assessed via two 6-minute blocks of visual observation, before and after tDCS. Duration of the behaviors observed will be collected in each block. Change in total duration between blocks will be calculated.
baseline and post intervention (approximately 90 minutes)
Study Arms (2)
active multifocal Transcranial Direct Current Stimulation (tDCS)
EXPERIMENTALparticipants receive 13-min of active multifocal tDCS targeting the left dorsolateral prefrontal cortex. tDCS will be delivered offline for 13 minutes (1.5mA, 10 seconds ramp in/out).
sham multifocal Transcranial Direct Current Stimulation (tDCS)
SHAM COMPARATORSham stimulation will be identical to active but electrical current will only be ramped in/out at the beginning and end of the 13-min period.
Interventions
tDCS will be delivered for 13 minutes (active) or only at the beginning and end of the 13 minute period (sham) using Neuroelectrics Instrument Controller software and a battery-driven Starstim 8-channel transcranial direct current stimulator with 1cm2 ceramic electrodes and SIGNAGEL conductive saline gel.
Participants will undergo three, twenty-second trials of exposure to individualized cues at the top of the established urge hierarchy, previously determined to precede picking or biting behaviors before and after tDCS.
Participants will be left in the testing room without access to a cellphone or reading materials for 2 different 6 minute periods.
Eligibility Criteria
You may qualify if:
- Ability to provide informed consent (as established by clinical interview), and voluntary, signed informed consent prior to the performance of any study specific
- Ability and willingness to perform study-relevant clinical assessments and tDCS
- Endorses mild to extreme intensity of urges to pick or bite their skin or nails
You may not qualify if:
- Any unstable medical, psychiatric, or neurological condition (including active or otherwise problematic suicidality) that may necessitate urgent treatment
- Daily use of psychotropic medications that substantially lower seizure threshold (e.g., clozapine)
- History of psychosis, mania, major neurological disorder, significant head trauma, or seizures/epilepsy
- Current suicidal intent
- Any major neurological disease or history of major head trauma, including concussion with extended loss of consciousness, or of psychosurgery
- Current or suspected pregnancy
- Endorsing possible contraindications for tDCS
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Kentucky
Lexington, Kentucky, 40506, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Gopalkumar Rakesh, MD
University of Kentucky
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
May 23, 2025
First Posted
June 13, 2025
Study Start
July 8, 2025
Primary Completion
May 1, 2026
Study Completion
May 1, 2026
Last Updated
July 23, 2025
Record last verified: 2025-07
Data Sharing
- IPD Sharing
- Will not share