Pilot Study of CBT With tDCS for Adults Being Treated for Obsessive Compulsive Disorder

NCT05964998 | Withdrawn FDA Device

• 1 other identifier: 22-ROGE-103
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

This pilot study aims to compare the effect of transcranial direct current stimulation (tDCS) versus sham stimulation, delivered immediately prior to cognitive-behavioral therapy (CBT) for obsessive-compulsive disorder (OCD), on patient-reported outcomes. The investigator hypothesize that patients who receive active stimulation will experience greater improvement in OCD symptoms than those who receive sham stimulation.

Conditions

Obsessive-Compulsive Disorder

Keywords

Obsessive-Compulsive Disorder; OCD; transcranial direct current stimulation; tDCS; Cognitive Behavior Therapy; CBT

Outcome Measures

Primary Outcomes (2)

• Change in Yale-Brown Obsessive-Compulsive Scale - Self-Report from admission to discharge

  Up to 12 weeks

• Change in Quick Inventory of Depressive Symptomology from admission to discharge

  Up to 12 weeks

Secondary Outcomes (5)

• Number of treatment days between admission and discharge

  Up to 12 weeks

• Change in Obsessive-Compulsive Inventory-Revised from admission to discharge

  Up to 12 weeks

• Change in Quality of life enjoyment and satisfaction questionnaire - short form from admission to discharge

  Up to 12 weeks

• Change in Intolerance of uncertainty scale from admission to discharge

  Up to 12 weeks

• Change in Subjective units of distress from admission to discharge

  Up to 12 weeks

Study Arms (2)

Active stimulation

EXPERIMENTAL

Device: transcranial direct current stimulation

Sham stimulation

SHAM COMPARATOR

Device: Sham transcranial direct current stimulation

Interventions

transcranial direct current stimulation DEVICE

Current will increase to 1.5 milliamps within 30 seconds and then maintain for 20 minutes

Active stimulation

Sham transcranial direct current stimulation DEVICE

Current will increase up to 1.5 milliamps within 30 seconds and then decrease back down over the next 30 seconds to 0 milliamps; subjects will received 0 milliamps for 20 minutes

Sham stimulation

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Primary diagnosis of Obsessive-Compulsive Disorder (OCD)
• Resident of state of Wisconsin
• Enrolled in OCD Intensive Outpatient Program (IOP) at Rogers Behavioral Health in Oconomowoc, WI
• Ability to communicate effectively using written and spoken English

You may not qualify if:

• Metal in the body of any kind (e.g., braces, pacemakers, metal plates or screws, intracranial electrodes, implanted devices/defibrillators, prostheses)
• Currently taking medication that reduces seizure threshold (e.g., clomipramine)
• Cranial pathologies (e.g., holes, plates)
• History of seizure or black-out concussion
• Pregnancy
• Previous treatment at Rogers Behavioral Health

Sponsors & Collaborators

• Rogers Behavioral Health: lead

Study Sites (1)

Rogers Behavioral Health

Oconomowoc, Wisconsin, 53066, United States

Location

MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Bradley C Riemann, PhD

  Rogers Behavioral Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants randomized to either active tDCS stimulation or sham.

Study Record Dates

• First Submitted: April 3, 2023
• First Posted: July 28, 2023
• Study Start: March 18, 2024
• Primary Completion: December 11, 2024
• Study Completion: December 11, 2024
• Last Updated: December 16, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)