Modulating Context Generalization Through Transcranial Direct Current Stimulation

NCT ID: NCT03374605

Last Updated: 2018-08-07

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-02-28
• Study Completion Date: 2019-12-31

Brief Summary

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.

Conditions

Anxiety and Fear

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

Active tDCS

Group Type: EXPERIMENTAL

active tDCS

Intervention Type: DEVICE

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 tDCS

Group Type: SHAM_COMPARATOR

sham tDCS

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Butler Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sarah Garnaat, PhD

Role: PRINCIPAL_INVESTIGATOR

Butler Hospital

Locations

Butler Hospital

Providence, Rhode Island, United States

Countries

United States

Other Identifiers

1705-002

Identifier Type: -

Identifier Source: org_study_id