Transcranial Direct Current Stimulation (tDCS) for Treatment-Resistant Obsessive-Compulsive Disorder (FRONT)

NCT02743715 | Completed

• 1 other identifier: FRONT2016
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

Neuromodulation techniques for the treatment of Obsessive-Compulsive Disorder (OCD) have expanded with the greater understanding of the brain circuits involved in this disorder. Transcranial direct current stimulation (tDCS) is a non-invasive neuromodulation technique that has been studied as an alternative for strategy for treatment-resistant OCD. The main study is a randomized, sham-controlled, double-blinded trial tDCS for OCD patients unresponsive to cognitive-behavioral therapy and/or selective serotonin reuptake inhibitors. Forty-four patients will be randomized to two groups: active or simulated intervention. The intervention consisted of delivering an electric current of 2mA to the cathode, positioned bilaterally in the cranial region corresponding to the supplementary motor cortex, and the anode positioned in the deltoid (neutral region), during 30-minutes, for four consecutive weeks. The primary outcome was the reduction in baseline YBOCS scores before and after of tDCS treatment. Secondary outcomes include measures of depressive and anxiety symptoms, genetic markers, motor cortical excitability and performance in neurocognitive tests.

Conditions

Obsessive-Compulsive Disorder

Keywords

Obsessive-Compulsive Disorder; Transcranial direct current stimulation; Neuromodulation

Outcome Measures

Primary Outcomes (1)

• change in baseline Yale-Brown Obsessive Compulsive Scale score

  weeks 4,6,9,12

Secondary Outcomes (3)

• Beck Depression Inventory symptoms,

  baseline, weeks 6 and 12

• Beck Anxiety Inventory

  baseline, week 6 and 12

• Global Clinical Impression Scale - improvement

  baseline, week 6 and 12

Study Arms (2)

Active tDCS

ACTIVE COMPARATOR

Electric current of 2mA delivered to the cathode, positioned bilaterally in the cranial region corresponding to the supplementary motor cortex, with the anode positioned in the deltoid (neutral region), in 30-minute sessions, 5 days a week (Mondays through Fridays) for four consecutive weeks.

Device: Active tDCS (transcranial direct current stimulation)

Sham tDCS

SHAM COMPARATOR

In this group, the cathode is positioned bilaterally in the cranial region corresponding to the supplementary motor cortex, with the anode positioned in the deltoid (neutral region), in 30-minute sessions, 5 days a week (Mondays through Fridays) for four consecutive weeks, without delivery of the electric current.

Device: Sham tDCS

Interventions

Active tDCS (transcranial direct current stimulation) DEVICE

An electrical current of 2mA is delivered to the cathode, positioned bilaterally in the cranial region corresponding to the supplementary motor cortex, with the anode positioned in the deltoid (neutral region), in 30-minute sessions, 5 days a week (Mondays through Fridays) for four consecutive weeks.

Active tDCS

Sham tDCS DEVICE

The cathode is positioned bilaterally in the cranial region corresponding to the supplementary motor cortex, with the anode positioned in the deltoid (neutral region), in a 30-minute session, 5 days a week (Mondays through Fridays) for four consecutive weeks, without delivery of the electric current.

Sham tDCS

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients diagnosed with OCD according to DSM IV criteria
• YBOCS score of 16 and above or ≥10 (for the presence of only compulsions or only obsessions)
• Patients with other psychiatric comorbidities are not excluded, however, OCD should be the most important disease .
• Age between 18 and 65
• Patients who failed one or more treatments
• Patients with no previous treatment for OCD will be treated with one first line treatment before being considered to participate in the tDCS trial.
• Voluntary and competent to consent

You may not qualify if:

• Other diagnostic axis I whose treatment take precedence over the treatment of OCD (bipolar affective disorder; dependence alcohol; schizophrenia or psychotic disorders; dementia)
• Presence of other neurological diseases or severe clinical as neurodegenerative diseases, severe aphasia, malignancies activity, epilepsy, previous head injury, congestive heart failure or chronic obstructive pulmonary disease stage III or IV;
• Presence of severe suicidal ideation (Structured planning suicide or attempted suicide in the past 4 weeks);
• Pregnancy;
• Inability to provide informed consent;
• Specific contraindication to tDCS: ( metal plates on the head, anatomic changes.);
• In relation to the current use of psychotropic drugs will be permitted, provided they are in doses stable for at least 6 weeks.

Sponsors & Collaborators

• University of Sao Paulo: lead
• Fundação de Amparo à Pesquisa do Estado de São Paulo: collaborator

Study Sites (1)

USP

São Paulo, Brazil

Location

Related Publications (1)

• Silva RM, Brunoni AR, Miguel EC, Shavitt RG. Transcranial direct current stimulation for treatment-resistant obsessive-compulsive disorder: report on two cases and proposal for a randomized, sham-controlled trial. Sao Paulo Med J. 2016 Sep-Oct;134(5):446-450. doi: 10.1590/1516-3180.2016.0155010716.

  PMID: 27901245 DERIVED

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 Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: all study staff were blind to the participant's condition; only the neuromodulation staff, external to the study team, were aware of the participant's treatment group
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD Department & Institute of Psychiatry Obsessive-Compulsive Spectrum Disorders Program University of Sao Paulo Medical School, Brazil

Model Details: randomized, sham-controlled trial

Study Record Dates

• First Submitted: April 7, 2016
• First Posted: April 19, 2016
• Study Start: April 1, 2016
• Primary Completion: August 1, 2018
• Study Completion: August 1, 2018
• Last Updated: December 29, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)