Transcranial Direct Current Stimulation and Extinction in Obsessive Compulsive Disorder

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorYale University

About this trial

Obsessive-compulsive disorder (OCD) is associated with substantial impairments in quality of life and is among the most disabling psychiatric disorders. Exposure therapy is among the first-line of treatments for obsessive-compulsive disorder (OCD) . Extinction learning is thought to be a core mechanism of therapeutic exposure. Fear and safety signal learning are traditionally associated with activity and connectivity within the canonical corticolimbic "fear circuit", which includes the amygdala, medial prefrontal cortex (mPFC), and hippocampus. Transcranial direct current stimulation (tDCS) is a neuromodulation technology that can augment brain plasticity, learning, and memory. The proposed study will test if obsessive-compulsive disorder (OCD) is associated with inhibitory safety learning deficits and if transcranial direct current stimulation (tDCS) normalizes functional connectivity and safety signal processing to recover extinction deficits in obsessive-compulsive disorder (OCD).

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

18 years of age or older

speak English fluently, and

able to provide written and verbal informed consent.

meet criteria for OCD as determined by structured clinical interview

Disqualifiers

active severe substance use disorder(s)

acute suicidality

history of bipolar or psychotic disorder(s)

significant developmental disabilities

Trial design

Design model

Parallel

Treatments tested in this trial

  • Active transcranial direct current stimulation

    Device

    Multifocal transcranial direct current stimulation will be delivered. The anode will be placed over the frontal pole (Fpz, 10-20 electroencephalogram \[EEG\]) and will be surrounded by 5 return electrodes (cathodes). Current will be set at 1.5mA and will be ramped in and out for 30 seconds at the beginning and end of a 20-minute stimulation period.

  • Sham transcranial direct current stimulation

    Device

    Multifocal transcranial direct current stimulation will be delivered. The anode will be placed over the frontal pole (Fpz, 10-20 electroencephalogram \[EEG\]) and will be surrounded by 5 return electrodes (cathodes). Current will be set at 1.5mA and will be ramped in and out for 30 seconds at the beginning of a 20-minute period.

Treatment groups

180 Participants
are divided into 2 treatment groups
Group A: Active transcranial direct current stimulationActive comparator 1 intervention
Group B: Sham transcranial direct current stimulationSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

Blood oxygen level-dependent (BOLD) response to create functional brain activation maps

Brain activity will be estimated with blood oxygen level-dependent (BOLD) response, which will be measured with magnetic resonance imaging (MRI).

Time frame
Blood oxygen level-dependent (BOLD) will be measured across 3 daily scan sessions separated by ~24 hours each; data will be reported from all 3 sessions.
2

Skin conductance response (SCR) will be measured by collecting electrodermal activity data from the left hand

Skin conductance data will be used as an index of anxious reactivity to experimental cues.

Time frame
Skin conductance will be measured across all 3 scan sessions, separated by ~24 hours each; data will be reported from all 3 sessions.
3

Threat expectancies will be measured by asking participants to rate the probability of receiving a shock using a 0-100 scale with zero equal to 0% chance and 100 equal to 100% chance; higher values are indicative of worse anxious reactivity

Threat expectancies will be used as an index of anxious reactivity to experimental cues.

Time frame
Threat expectancies will be assessed at the beginning and end of each of the 3 scan session, separated by ~24-hours each; data will be reported from all 3 sessions.
4

Functional brain connectivity will be measured blood oxygen level dependent (BOLD) response

Correlations in brain activity between regions and networks measured with blood oxygen level dependent (BOLD) response captured with magnetic resonance imaging (MRI)

Time frame
Resting functional connectivity will be measured at baseline during first scan session and during transcranial direct current stimulation in the second scan session; scan sessions will be separated by ~24 hours; data from both sessions will be reported.

Secondary outcomes

Other outcomes

Sponsors and contacts

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Yale University

Lead sponsor

National Institute of Mental Health (NIMH)

Collaborator