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RecruitingNCT07019571Updated Jul 23, 2025

tDCS and Urge in BFRBs

An interventional study of Wireless Multichannel Transcranial Current Stimulator (tDCS) and Cue exposure in Repetitive Compulsive Behavior, sponsored by Gopalkumar Rakesh. Recruiting at 1 site in United States. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2025-07-23.

Sponsored by Gopalkumar Rakesh · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by May 2026, 5 months ago, but the record still lists the study as recruiting.
  • Started Jul 2025; still recruiting 1 year 3 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
55
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study 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.
02

Conditions studied

  • Repetitive Compulsive Behavior

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Keywords

  • picking
  • biting
  • transcranial stimulation
03

In context

Bites and Stings

112 studies on the registry are indexed under Bites and Stings; 45 are open to participants now.

This study's planned enrollment of 55 is close to the median of 60 across 89 interventional studies indexed under Bites and Stings.

Browse Bites and Stings studies →

Lead sponsor

Gopalkumar Rakesh is the lead sponsor of 7 studies on the registry; 1 is open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 4 (80%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
55 participants (estimated)

Study 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).

    Device: Wireless Multichannel Transcranial Current Stimulator (tDCS) · Behavioral: Cue exposure · Behavioral: Boredom induction

  • 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.

    Device: Wireless Multichannel Transcranial Current Stimulator (tDCS) · Behavioral: Cue exposure · Behavioral: Boredom induction

Interventions

  • DeviceWireless 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.

  • BehavioralCue 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.

  • BehavioralBoredom induction

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

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: baseline and post intervention, approximately 90 minutes

  2. 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.

    Time frame: baseline and post intervention, approximately 90 minutes

  3. 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.

    Time frame: baseline and post intervention (approximately 90 minutes)

  4. 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.

    Time frame: baseline and post intervention (approximately 90 minutes)

07

Study locations

1 of 1 sites recruiting
  • University of Kentucky
    Lexington, Kentucky 40506, United States
    • Hannah Wild · Contact · hannah.wild@uky.edu · 859-414-6962
    • Gopalkumar Rakesh, MD · Principal investigator
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 23, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07019571
Lead sponsor
Gopalkumar Rakesh
Responsible party
Gopalkumar Rakesh (Assistant Professor, University of Kentucky) — Sponsor-investigator
First posted
Jun 13, 2025
Start date
Jul 8, 2025
Primary completion
May 2026 (estimated)
Completion
May 2026 (estimated)
Last update
Jul 23, 2025

Study contacts

Hannah Wild, M.S.
Contact
hannah.wild@uky.edu
‪(859) 414-6962‬
Gopalkumar Rakesh, MD
study director · University of Kentucky

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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