Repetitive Compulsive BehaviorNCT07019571
tDCS and Urge in BFRBs
A study testing Wireless Multichannel Transcranial Current Stimulator (tDCS), Cue exposure and Boredom induction in people with Repetitive Compulsive Behavior, run by Gopalkumar Rakesh at 1 site in United States.
Trial 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: 1. Does brain stimulation reduce the urge to pick skin or bite nails after those urges are triggered? 2. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Repetitive Compulsive Behavior
- What is being tested?
- Wireless Multichannel Transcranial Current Stimulator (tDCS), Cue exposure and Boredom induction
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 55 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jul 2025to May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Kentucky
Lexington, Kentucky, 40506
Hannah Wild, 859-414-6962, hannah.wild@uky.edu
Gopalkumar Rakesh, MD
About this study
Official title: Evaluating the Impact of Transcranial Direct Current Stimulation on Urge in Body-Focused Repetitive Behaviors
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:
- Does brain stimulation reduce the urge to pick skin or bite nails after those urges are triggered?
- Does brain stimulation reduce how often people pick their skin or bite their nails?
Read more
Participants will:
- 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.
- Conditions
- Repetitive Compulsive Behavior
- Being tested
- Wireless Multichannel Transcranial Current Stimulator (tDCS), Cue exposure, Boredom induction
- Keywords
- picking, biting, transcranial stimulation
- Medical subject headings
- Bites and Stings
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wireless Multichannel Transcranial Current Stimulator (tDCS)Device
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.
Cue exposureBehavioural
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.
Boredom inductionBehavioural
Participants will be left in the testing room without access to a cellphone or reading materials for 2 different 6 minute periods.
| Study group | Role | What they receive |
|---|---|---|
| active multifocal Transcranial Direct Current Stimulation (tDCS) | Experimental | participants 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). Receives: Device: Wireless Multichannel Transcranial Current Stimulator (tDCS); Behavioral: Cue exposure; Behavioral: Boredom induction |
| sham multifocal Transcranial Direct Current Stimulation (tDCS) | Sham comparator | Sham 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. Receives: Device: Wireless Multichannel Transcranial Current Stimulator (tDCS); Behavioral: Cue exposure; Behavioral: Boredom induction |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: baseline and post intervention (approximately 90 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2025
- Study start8 Jul 2025
- Primary completionMay 2026 (estimated)
- Study completionMay 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Repetitive Compulsive BehaviorStudies of the same condition, open and under way.
- 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 55 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gopalkumar Rakesh
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Gopalkumar Rakesh, University of Kentucky
- Investigators
- Gopalkumar Rakesh, MD, Study director, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07019571
- Sponsor's protocol ID
- 101505
- Status last verified
- Jul 2025
- First submitted
- 23 May 2025
- Last updated
- 23 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Impact of Transcranial Direct Current Stimulation on Urge in Body-Focused Repetitive Behaviors
- ClinicalTrials.gov ID
- NCT07019571
- Acronym / sponsor ID
- 101505
- Conditions
- Repetitive Compulsive Behavior
- Keywords
- picking, biting, transcranial stimulation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- Gopalkumar RakeshUniversity, hospital or other
- Study start
- 8 Jul 2025 (actual)
- Primary completion
- May 2026 (estimated)
- Study completion
- May 2026 (estimated)
- First posted
- 13 Jun 2025 (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.
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:
- Does brain stimulation reduce the urge to pick skin or bite nails after those urges are triggered?
- Does brain stimulation reduce how often people pick their skin or bite their nails?
Participants will:
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| active multifocal Transcranial Direct Current Stimulation (tDCS) | Experimental | Device: Wireless Multichannel Transcranial Current Stimulator (tDCS), Behavioral: Cue exposure, Behavioral: Boredom inductionparticipants 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 comparator | Device: Wireless Multichannel Transcranial Current Stimulator (tDCS), Behavioral: Cue exposure, Behavioral: Boredom inductionSham 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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
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 |
|---|---|---|
| Wireless Multichannel Transcranial Current Stimulator (tDCS)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. | Device | active multifocal Transcranial Direct Current Stimulation (tDCS), sham multifocal Transcranial Direct Current Stimulation (tDCS) |
| Cue exposureParticipants 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. | Behavioural | active multifocal Transcranial Direct Current Stimulation (tDCS), sham multifocal Transcranial Direct Current Stimulation (tDCS) |
| Boredom inductionParticipants will be left in the testing room without access to a cellphone or reading materials for 2 different 6 minute periods. | Behavioural | active multifocal Transcranial Direct Current Stimulation (tDCS), sham multifocal Transcranial Direct Current Stimulation (tDCS) |
Primary outcome
Change in subjective urge
Time frame: baseline and post intervention, approximately 90 minutes
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.
Change in subjective distress
Time frame: baseline and post intervention, approximately 90 minutes
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.
Change in picking or biting behavioral frequency
Time frame: baseline and post intervention (approximately 90 minutes)
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.
Change in picking or biting behaviors duration
Time frame: baseline and post intervention (approximately 90 minutes)
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2025.
- Individual participant dataSharing planned: No
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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.
Gopalkumar Rakesh, MD study director
University of Kentucky
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wireless Multichannel Transcranial Current Stimulator (tDCS), Cue exposure and Boredom induction in people with Repetitive Compulsive Behavior, run by Gopalkumar Rakesh at 1 site in United States.
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 7 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: looking for participants now, as of the sponsor's last update on 23 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hannah Wild, M.S. ((859) 414-6962, hannah.wild@uky.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in subjective urge (time frame: baseline and post intervention, approximately 90 minutes). The study lists 4 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 23 Jul 2025.