tDCS and Urge in BFRBs

Gopalkumar Rakesh

Status: Enrolling

Conditions: Repetitive Compulsive Behavior

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

Study type: Interventional

Funder types: Other

Identifiers

NCT07019571

101505

Details and patient eligibility

About

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.

Enrollment: 55 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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55 participants in 2 patient groups

active multifocal Transcranial Direct Current Stimulation (tDCS)

Experimental group

Description:

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).

Treatment:

Device: Wireless Multichannel Transcranial Current Stimulator (tDCS)

Behavioral: Boredom induction

Behavioral: Cue exposure

sham multifocal Transcranial Direct Current Stimulation (tDCS)

Sham Comparator group

Description:

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.

Treatment:

Device: Wireless Multichannel Transcranial Current Stimulator (tDCS)

Behavioral: Boredom induction

Behavioral: Cue exposure