tDCS and Urge in BFRBs

NCT ID: NCT07019571

Last Updated: 2025-07-23

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 55 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-08
• Study Completion Date: 2026-05-31

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:

1. Does brain stimulation reduce the urge to pick skin or bite nails after those urges are triggered?

2. 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.

Conditions

Repetitive Compulsive Behavior

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

active multifocal Transcranial Direct Current Stimulation (tDCS)

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).

Group Type: EXPERIMENTAL

Wireless Multichannel Transcranial Current Stimulator (tDCS)

Intervention Type: 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 exposure

Intervention Type: BEHAVIORAL

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 induction

Intervention Type: BEHAVIORAL

Participants will be left in the testing room without access to a cellphone or reading materials for 2 different 6 minute periods.

sham multifocal Transcranial Direct Current Stimulation (tDCS)

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.

Group Type: SHAM_COMPARATOR

Wireless Multichannel Transcranial Current Stimulator (tDCS)

Intervention Type: 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 exposure

Intervention Type: BEHAVIORAL

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 induction

Intervention Type: BEHAVIORAL

Participants will be left in the testing room without access to a cellphone or reading materials for 2 different 6 minute periods.

Interventions

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.

Intervention Type: DEVICE

Cue exposure

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.

Intervention Type: BEHAVIORAL

Boredom induction

Participants will be left in the testing room without access to a cellphone or reading materials for 2 different 6 minute periods.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gopalkumar Rakesh

OTHER

Sponsor Role: lead

Responsible Party

Gopalkumar Rakesh

Assistant Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Gopalkumar Rakesh, MD

Role: STUDY_DIRECTOR

University of Kentucky

Locations

University of Kentucky

Lexington, Kentucky, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Hannah Wild, M.S.

Role: CONTACT

hannah.wild@uky.edu

‪(859) 414-6962‬

Facility Contacts

Hannah Wild

Role: primary

hannah.wild@uky.edu

859-414-6962

Other Identifiers

101505

Identifier Type: -

Identifier Source: org_study_id