Recruiting

Brain Stimulation

Sponsor:

Gopalkumar Rakesh

Code:

NCT07019571

Conditions

Repetitive Compulsive Behavior

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Not accepted

Interventions

Wireless Multichannel Transcranial Current Stimulator (tDCS)

Cue exposure

Boredom induction

Study Details

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 ID

NCT07019571

Start date

Jul 8, 2025

Status verified date

Jul, 2025

Completion date

May, 2026

Anticipated

Primary completion date

May, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

55 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 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).

sham comparator: 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.

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.

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.

Boredom induction

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

Primary outcome measure

  • Change in subjective urge [ Time Frame: baseline and post intervention, approximately 90 minutes ]
  • Change in subjective distress [ Time Frame: baseline and post intervention, approximately 90 minutes ]
  • Change in picking or biting behavioral frequency [ Time Frame: baseline and post intervention (approximately 90 minutes) ]
  • Change in picking or biting behaviors duration [ Time Frame: baseline and post intervention (approximately 90 minutes) ]

Central Contacts and Locations

Central contacts

Locations

University of Kentucky

Recruiting

Lexington, Kentucky, United States, 40506

Contacts

Principal Investigator:

Gopalkumar Rakesh, MD

More Information

Sponsor

Gopalkumar Rakesh

Last update posted

Jul 23, 2025

Last verified

Jul, 2025

Keywords

  • picking
  • biting
  • transcranial stimulation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Gopalkumar Rakesh on 2025-07-23.