Anxiety DisordersNCT03275337
Cerebellar Neuromodulation to Enhance Fear Extinction and Predict Response to Exposure Therapy
A study testing Transcranial Direct Current Stimulation in people with Anxiety Disorders and Social Phobia, run by Laureate Institute for Brain Research, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Anxiety Disorders, Social Phobia
- What is being tested?
- Transcranial Direct Current Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2017to 31 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Generalize Anxiety or Social Phobia with an OASIS score =>8
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Laureate Institute for Brain Research
Tulsa, Oklahoma, 74011
About this study
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.
- Conditions
- Anxiety Disorders, Social Phobia
- Being tested
- Transcranial Direct Current Stimulation
- Keywords
- Social Phobia, Anxiety, Cerebellum, tDCS, Neuromodulation, Fear Extinction
- Medical subject headings
- Anxiety Disorders, Phobia, Social
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial Direct Current StimulationDevice
Also called tDCS
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.
| Study group | Role | What they receive |
|---|---|---|
| Anodal tDCS | Experimental | Anodal tDCS will be performed over bilateral cerebellar hemispheres for 20-minutes. Receives: Device: Transcranial Direct Current Stimulation |
| Cathodal tDCS | Experimental | Cathodal tDCS will be performed over bilateral cerebellar hemispheres for 20-minutes. Receives: Device: Transcranial Direct Current Stimulation |
| Sham tDCS | Active comparator | Sham tDCS will be performed over bilateral cerebellar hemispheres for 20-minutes. Receives: Device: Transcranial Direct Current Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Activation of ventromedial prefrontal cortex after cerebellar stimulation
Activation of vmPFC
Measured: Phase 1, Years 1-3
Secondary outcomes (2)
Change in resting state connectivity between vmPFC and cerebellar stimulation target
Change in resting state connectivity between vmPFC and cerebellum after cerebellar stimulation
Measured: Phase 1, Years 1-3
Baseline cerebellar-cerebral connectivity prediction of exposure therapy outcomes
Baseline cerebellar-cerebral connectivity prediction of exposure therapy outcomes
Measured: Phase 2, Years 3-5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2017
- Study start1 Aug 2017
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anxiety DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laureate Institute for Brain Research, Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yoon-Hee Cha, MD, Principal investigator, Laureate Institute for Brain Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03275337
- Sponsor's protocol ID
- 2017_001_01
- Status last verified
- Aug 2020
- First submitted
- 5 Sep 2017
- Last updated
- 1 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cerebellar Neuromodulation to Enhance Fear Extinction and Predict Response to Exposure Therapy
- ClinicalTrials.gov ID
- NCT03275337
- Acronym / sponsor ID
- 2017_001_01
- Conditions
- Anxiety Disorders, Social Phobia
- Keywords
- Social Phobia, Anxiety, Cerebellum, tDCS, Neuromodulation, Fear Extinction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Laureate Institute for Brain Research, Inc.University, hospital or other
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 7 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Anodal tDCS | Experimental | Device: Transcranial Direct Current StimulationAnodal tDCS will be performed over bilateral cerebellar hemispheres for 20-minutes. |
| Cathodal tDCS | Experimental | Device: Transcranial Direct Current StimulationCathodal tDCS will be performed over bilateral cerebellar hemispheres for 20-minutes. |
| Sham tDCS | Active comparator | Device: Transcranial Direct Current StimulationSham tDCS will be performed over bilateral cerebellar hemispheres for 20-minutes. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Generalize Anxiety or Social Phobia with an OASIS score =>8
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcranial Direct Current StimulationAlso: tDCStDCS 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. | Device | Anodal tDCS, Cathodal tDCS, Sham tDCS |
Primary outcome
Activation of ventromedial prefrontal cortex after cerebellar stimulation
Time frame: Phase 1, Years 1-3
Activation of vmPFC
2 secondary outcomes
Change in resting state connectivity between vmPFC and cerebellar stimulation target
Time frame: Phase 1, Years 1-3
Baseline cerebellar-cerebral connectivity prediction of exposure therapy outcomes
Time frame: Phase 2, Years 3-5
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yoon-Hee Cha, MD principal investigator
Laureate Institute for Brain Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial Direct Current Stimulation in people with Anxiety Disorders and Social Phobia, run by Laureate Institute for Brain Research, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Activation of ventromedial prefrontal cortex after cerebellar stimulation (time frame: Phase 1, Years 1-3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2020.