Cerebellar Neuromodulation to Enhance Fear Extinction and Predict Response to Exposure Therapy

NCT03275337 | Completed FDA Device

• 1 other identifier: 2017_001_01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Emerging neuroimaging studies have shown that the cerebellum contributes to different aspects of timing, prediction, learning, and extinction of conditioned responses to aversive stimuli, factors that may be relevant to the success of exposure based behavioral therapy. Our goals are to determine the cerebellar contributions to fear extinction by attempting to modulate key pathways in this process by theta burst stimulation. The long term goal is to lay the foundation for future studies in which neuromodulation is used to augment exposure therapy.

Conditions

Anxiety Disorders; Social Phobia

Keywords

Social Phobia; Anxiety; Cerebellum; tDCS; Neuromodulation; Fear Extinction

Outcome Measures

Primary Outcomes (1)

• Activation of ventromedial prefrontal cortex after cerebellar stimulation

  Activation of vmPFC

  Phase 1, Years 1-3

Secondary Outcomes (2)

• Change in resting state connectivity between vmPFC and cerebellar stimulation target

  Phase 1, Years 1-3

• Baseline cerebellar-cerebral connectivity prediction of exposure therapy outcomes

  Phase 2, Years 3-5

Study Arms (3)

Anodal tDCS

EXPERIMENTAL

Anodal tDCS will be performed over bilateral cerebellar hemispheres for 20-minutes.

Device: Transcranial Direct Current Stimulation

Cathodal tDCS

EXPERIMENTAL

Cathodal tDCS will be performed over bilateral cerebellar hemispheres for 20-minutes.

Device: Transcranial Direct Current Stimulation

Sham tDCS

ACTIVE COMPARATOR

Sham tDCS will be performed over bilateral cerebellar hemispheres for 20-minutes.

Device: Transcranial Direct Current Stimulation

Interventions

Transcranial Direct Current Stimulation DEVICE

tDCS is a non-invasive form of neuromodulation in which direct current is administered placed over a brain region of interest to induce physiological changes such as inhibition or excitation over that region.

Also known as: tDCS

Anodal tDCS; Cathodal tDCS; Sham tDCS

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Generalize Anxiety or Social Phobia with an OASIS score =\>8

You may not qualify if:

• Safety concerns related to undergoing an fMRI scan or tDCS, such as metal in the head, history of unprovoked seizures in self or a first-degree family member, medications that reduce seizure threshold, pregnant or planning to become pregnant.
• History of Post Traumatic Stress Disorder, Obsessive Compulsive Disorder, Panic Disorder, Current Major Depressive Illness, Substance Abuse in the past 1-year, or any thought disorder such as schizophrenia or bipolar disorder.

Sponsors & Collaborators

• Laureate Institute for Brain Research, Inc.: lead

Study Sites (1)

Laureate Institute for Brain Research

Tulsa, Oklahoma, 74011, United States

Location

MeSH Terms

Conditions

Anxiety Disorders; Phobia, Social

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Mental Disorders; Phobic Disorders

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Yoon-Hee Cha, MD

  Laureate Institute for Brain Research

  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: September 5, 2017
• First Posted: September 7, 2017
• Study Start: August 1, 2017
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: September 1, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)