ClinicalTrials.gg
CompletedNCT03275337Updated Sep 1, 2020

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

An interventional study of Transcranial Direct Current Stimulation in Anxiety Disorders and Social Phobia, sponsored by Laureate Institute for Brain Research, Inc.. Completed at 1 site in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2020-09-01.

Primary conditionPhobia, SocialRegistry: Anxiety DisordersReclassifiedWhy we changed it
Registry
Anxiety Disorders — the first condition term the registry derived for this study.
ClinicalTrials.gg
Phobia, Social
Why
  1. The registry often attaches Anxiety Disorders to studies about something else, and this study's title and listed conditions do not name it.
  2. The study's listed conditions name Phobia, Social, a narrower term within Anxiety Disorders.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Laureate Institute for Brain Research, Inc. · Not applicable, Interventional, and Basic science

From the registry’s dates

  • Primary completion was Dec 2019, 6 years 10 months ago, and no results have been posted to the registry.
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 187 studies in Phobia, Social with a site in United States — 23 open to participants now, 29 under way, 1 of them phase 3. Phobia, Social · United States.

Enrollment
94th of 178
60 · median 64
Started
2017
with 10 others
No phase
100 of 187
17 open now
Registered
106th of 187
by date

Among the 187 studies in Phobia, Social with a site in United States, this one is the 94th largest by enrollment of the 178 interventional ones that give a count, is one of 11 that started in 2017, is one of 100 with no phase, and was the 106th registered.

Phobia, Social

368 studies on the registry are indexed under Phobia, Social; 59 are open to participants now.

Browse Phobia, Social studies →

Open to participants now

23 of the 187 studies in Phobia, Social with a site in United States are open now. Recruiting first, the newest first:

18 more — sign in →

All 23 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 46 Phobia, Social studies recruiting now, 10 (22%) set no upper age limit and 34 (74%) stop at 75 or younger; 14 take children under 18; 8 take healthy volunteers.

This study: 18 Years to 70 Years · all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 187 studies in Phobia, Social with a site in United States, or all of them as a file.
02

Study 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.

Read the detailed description

Participants in this study will undergo an assessment for past history and present symptoms of mood, anxiety, trauma, substance abuse, and eating disorders. Safety screening for functional MRI (fMRI) and repetitive transcranial magnetic stimulation (rTMS) will be performed prior to enrollment.

Phase 1 of the study involves two visits. The first visit involves undergoing an fMRI scan and a motor thresholding procedure for rTMS. A clinical assessment will be performed for the above symptoms, or a recap of symptoms if the participant had been previously assessed at our institute.

The second visit involves a fear conditioning session performed in the fMRI scanner followed by one session of rTMS over either a cerebellar or occipital lobe (control) target. This will be immediately followed by a fear extinction phase, also in the fMRI scanner. The participant will return in 24hours to determine consolidation of the fear extinction process.

Phase 2 is similar to Phase 1, except that each participant will undergo two sessions of the fear conditioning and fear extinction phases while undergoing an fMRI scan. In one session, they will receive rTMS over a cerebellar target. In the other session, they will receive rTMS over a control site. These sessions will be separated by at least 1 week.

The participants will then undergo 10 weeks of exposure therapy for social phobia. The goal is to determine whether neuroplasticity related to cerebellar stimulation can predict the response to exposure therapy.

03

Conditions studied

  • Anxiety Disorders
  • Social Phobia

Browse trials for

Keywords

  • Social Phobia
  • Anxiety
  • Cerebellum
  • tDCS
  • Neuromodulation
  • Fear Extinction
04

In context

Phobia, Social Reclassified

368 studies on the registry are indexed under Phobia, Social; 59 are open to participants now.

This study's enrollment of 60 is below the median of 76 across 339 interventional studies indexed under Phobia, Social.

Browse Phobia, Social studies →

Lead sponsor

Laureate Institute for Brain Research, Inc. is the lead sponsor of 54 studies on the registry; 11 are open to participants now.

Compared within Phobia, Social, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Anxiety Disorders. The counts are of registry records indexed under each term, refreshed daily. How we classify →

05

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • 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.
06

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
60 participants (actual)

Study arms

  • Experimental
    Anodal tDCS

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

    Device: Transcranial Direct Current Stimulation

  • Experimental
    Cathodal tDCS

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

    Device: Transcranial Direct Current Stimulation

  • Active comparator
    Sham tDCS

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

    Device: Transcranial Direct Current Stimulation

Interventions

  • DeviceTranscranial Direct Current Stimulation

    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

07

What researchers measure

Primary outcomes

  1. Activation of ventromedial prefrontal cortex after cerebellar stimulation

    Activation of vmPFC

    Time frame: Phase 1, Years 1-3

Secondary outcomes

  1. Change in resting state connectivity between vmPFC and cerebellar stimulation target

    Change in resting state connectivity between vmPFC and cerebellum after cerebellar stimulation

    Time frame: Phase 1, Years 1-3

  2. Baseline cerebellar-cerebral connectivity prediction of exposure therapy outcomes

    Baseline cerebellar-cerebral connectivity prediction of exposure therapy outcomes

    Time frame: Phase 2, Years 3-5

08

Study locations

1 site
  • Laureate Institute for Brain Research
    Tulsa, Oklahoma 74011, United States
09

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Aug 2017 to primary completion in Dec 2019, 28 months.

Of 142 non-industry interventional studies with no phase under Phobia, Social, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 44. This study's 28 months is close to that.

Counting every sponsor, half of 148 studies reached it within 28 months; a quarter within 14 and three quarters within 43.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 5, 2017
First posted
Sep 7, 2017
StartActual
Aug 1, 2017
Primary completionActual
Dec 31, 2019
CompletionActual
Dec 31, 2019
Last update
Sep 1, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 1, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03275337
Lead sponsor
Laureate Institute for Brain Research, Inc.
Responsible party
Sponsor
First posted
Sep 7, 2017
Start date
Aug 1, 2017
Primary completion
Dec 31, 2019
Completion
Dec 31, 2019
Last update
Sep 1, 2020

Study contacts

Yoon-Hee Cha, MD
principal investigator · Laureate Institute for Brain Research

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2020. You cannot join it, but the record below documents what was studied.

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