Modulating Context Generalization Through Transcranial Direct Current Stimulation

Anxiety and Fear Clinical Trial

Official title:

Modulating Context Generalization Through Transcranial Direct Current Stimulation

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03374605
• Other study ID #: 1705-002
• Status: Withdrawn
• Phase: N/A
• Start date: February 2018
• Est. completion date: December 2019

Study information

• Verified date: August 2018
• Source: Butler Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2019
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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).

Related Conditions & MeSH terms

• Anxiety and Fear

Intervention

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 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.

Locations

Country	Name	City	State
United States	Butler Hospital	Providence	Rhode Island

Sponsors (1)

Lead Sponsor	Collaborator
Butler Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Relative frequency of selection of task-specific stimuli		1 hour (measurement occurs 1 time only)