Modulating Context Generalization Through Transcranial Direct Current Stimulation

Behavioral adaptation is particularly relevant to anxiety and related disorders, where exposure-based therapies rely on such adaptation as part of behavior therapy.. However, while initial fear reactions generalize easily across contexts, subsequent adaption of behavior through learning is context-specific. The primary goal of this study is to investigate whether transcranial direct current stimulation (tDCS) can be used to acutely impact generalization of subsequent learning across contexts in an experimental paradigm. As part of this study, participants will complete a clinical interview and questionnaires, as well as a computer task asking them to make choices between stimuli on the screen and during which they may or may not receive tDCS.

Study Overview

• Status: Withdrawn
• Conditions: Anxiety and Fear
• Intervention / Treatment: Device: active tDCS; Device: sham tDCS

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Rhode Island
    • Providence, Rhode Island, United States, 02906
      • Butler Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Primary diagnosis of an anxiety or related disorder, (defined as panic disorder, social anxiety disorder, generalized anxiety disorder, obsessive-compulsive disorder, and/or post-traumatic stress disorder);
2. aged 18-55;
3. ability to speak, read, write, and understand English sufficiently well to complete study procedures and provide informed consent;
4. Stable psychiatric medication use for at least 6 weeks.

Exclusion Criteria:

1. Lifetime history of psychotic symptoms or bipolar disorder,
2. Current substance use disorder;
3. Acute suicidality or homicidality,
4. Significant neurological disorder,
5. Any problems that would interfere with study participation, significant or unstable medical disorders and tDCS-related contraindications (e.g., implanted metallic substances, pregnancy, holes in the skull, skin abnormalities under stimulation sites).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Active tDCS	Device: active tDCS; 15 minutes of active (2mA) high definition tDCS will be applied to the participant's skull. The anodal electrode will be placed over 10-20 EEG coordinate AF7 and cathodal electrode over coordinate Fz.
Sham Comparator: Sham tDCS	Device: sham tDCS; 15 minutes of sham high definition tDCS will be applied to the participant's skull. The anodal electrode will be placed over 10-20 EEG coordinate AF7 and cathodal electrode over coordinate Fz.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Relative frequency of selection of task-specific stimuli	1 hour (measurement occurs 1 time only)

Collaborators and Investigators

• Sponsor: Butler Hospital
• Investigators: Principal Investigator: Sarah Garnaat, PhD, Butler Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): February 1, 2018
• Primary Completion (Anticipated): December 1, 2019
• Study Completion (Anticipated): December 1, 2019

Study Registration Dates

• First Submitted: December 12, 2017
• First Submitted That Met QC Criteria: December 12, 2017
• First Posted (Actual): December 15, 2017

Study Record Updates

• Last Update Posted (Actual): August 7, 2018
• Last Update Submitted That Met QC Criteria: August 6, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: 1705-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No