Modulating Context Generalization Through Transcranial Direct Current Stimulation

NCT03374605 | Withdrawn

• 1 other identifier: 1705-002
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Relative frequency of selection of task-specific stimuli

  1 hour (measurement occurs 1 time only)

Study Arms (2)

Active tDCS

EXPERIMENTAL

Device: active tDCS

Sham tDCS

SHAM COMPARATOR

Device: sham tDCS

Interventions

active tDCS 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.

Active tDCS

sham tDCS 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.

Sham tDCS

Eligibility Criteria

• Age: 18 Years - 55 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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);
• aged 18-55;
• ability to speak, read, write, and understand English sufficiently well to complete study procedures and provide informed consent;
• Stable psychiatric medication use for at least 6 weeks.

You may not qualify if:

• Lifetime history of psychotic symptoms or bipolar disorder,
• Current substance use disorder;
• Acute suicidality or homicidality,
• Significant neurological disorder,
• 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).

Sponsors & Collaborators

• Butler Hospital: lead

Study Sites (1)

Butler Hospital

Providence, Rhode Island, 02906, United States

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Sarah Garnaat, PhD

  Butler Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2017
• First Posted: December 15, 2017
• Study Start: February 1, 2018
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: August 7, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)