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Completed

NCT Number: NCT02743715

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

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.

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Key information

Conditions

Obsessive-Compulsive Disorder Anxiety Disorders Mental Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

USP

São Paulo, Brazil

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

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.

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.

Primary outcomes

  1. change in baseline Yale-Brown Obsessive Compulsive Scale score

    Time frame: weeks 4,6,9,12

Secondary outcomes

  1. Beck Depression Inventory symptoms,

    Time frame: baseline, weeks 6 and 12

  2. Beck Anxiety Inventory

    Time frame: baseline, week 6 and 12

  3. Global Clinical Impression Scale - improvement

    Time frame: baseline, week 6 and 12

Sponsors and collaborators

Lead sponsor

University of Sao Paulo

Other

Collaborators

  • Fundação de Amparo à Pesquisa do Estado de São Paulo

Registry information

Official study title

Randomized, Sham-Controlled Trial of Transcranial Direct Current Stimulation (tDCS) for Treatment-Resistant Obsessive-Compulsive Disorder (FRONT)

Acronym: FRONT

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Apr 19, 2016
Registry last updated
Dec 29, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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