Obsessive Compulsive Disorder (OCD)CBT-TMSNCT02528331
Cognitive Behavioral Strategies and Transcranial Magnetic Stimulation in Obsessive-Compulsive Disorder: Open Label Study
A study testing Transcranial magnetic stimulation and Cognitive behavioral therapy in people with Obsessive Compulsive Disorder (OCD), run by Duke University at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the effectiveness of repetitive TMS (rTMS) delivered simultaneously with elements of cognitive behavioral therapy/exposure-response prevention (CBT/ERP) in adult subjects (greater or equal to 18 years old) with obsessive-compulsive disorder (OCD). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obsessive Compulsive Disorder (OCD)
- What is being tested?
- Transcranial magnetic stimulation and Cognitive behavioral therapy
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2016to Aug 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects must meet all of the following inclusion criteria to qualify for enrollment into the study:
- All subjects will be 18 - 65 years of age.
- Obsessive-compulsive disorder:
- Subjects will meet the DSM-IV primary diagnosis of obsessive-compulsive
- Y-BOCS total score > 16
- Subjects are willing and able to adhere to the intensive treatment schedule and all required study visits.
Who cannot join
- Subjects will be excluded from study participation if one of the following exclusion criteria applies:
- Subjects are unable or unwilling to give informed consent.
- No exclusion criteria for comorbid DSM diagnosis.
- Subjects with a clinically defined neurological disorder that caused significant safety concern to receive TMS treatment, including, but not limited to:
- Any condition likely to be associated with increased intracranial pressure.
- Space occupying brain lesion.
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- Any history of seizure EXCEPT those therapeutically induced by ECT (childhood febrile seizures are acceptable and these subjects may be included in the study).
- History of stroke.
- Transient ischemic attack within two years.
- Cerebral aneurysm.
- Dementia.
- Mini Mental Status Exam (MMSE-2) score of <24.
- Parkinson's disease.
- Huntington's disease.
- Multiple sclerosis.
- Increased risk of seizure for any reason, including prior diagnosis of increased intracranial pressure (such as after large infarctions or trauma), or currently taking medication that lowers the seizure threshold. Medications that lower the seizure threshold are included in the Prohibited Concomitant Medication (Section 5.8).
- Subjects with any of the following treatment histories:
- TMS treatment within 6 months prior to the screening visit.
- Lifetime history of treatment with Deep Brain Stimulation
- Use of any investigational drug or device within 4 weeks of the randomization visit.
- If participating in psychotherapy, must have been in stable treatment for at least 2 months prior to entry into the study, with no anticipation of change in the frequency of therapeutic sessions, or the therapeutic focus over the duration of the trial.
- Recent 2-month medication changes
- Contraindication to receive TMS:
- Cardiac pacemakers, implanted medication pumps, intracardiac lines, or acute, unstable cardiac disease.
- Intracranial implant (e.g., aneurysm clips, shunts, stimulators, cochlear implants, stents, or electrodes) or any other metal object within or near the head, excluding the mouth, which cannot be safely removed.
- Clinically significant abnormality or clinically significant unstable medical condition, as indicated by medical history, physical examination, ECG results, or clinical laboratory testing, that in the Investigator's judgment might pose a potential safety risk to the subject or limit interpretation of the trial results, e.g., any uncontrolled thyroid disorders, hepatic, cardiac, pulmonary and renal malfunctioning.
- Women who are currently pregnant or not using a medically acceptable means of birth control and women who are breastfeeding.
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27705
About this study
The purpose of this study is to evaluate the effectiveness of repetitive TMS (rTMS) delivered simultaneously with elements of cognitive behavioral therapy/exposure-response prevention (CBT/ERP) in adult subjects (greater or equal to 18 years old) with obsessive-compulsive disorder (OCD). This is an open label study that involves standard of care for OCD (CBT) and an investigational treatment modality (TMS). The investigators will compare the Yale-Brown Obsessive Compulsive Scale (YBOCS) scores before and after treatment to quantify clinical improvement. The side effects from TMS include, but are not limited to, headache, seizure, and general pain. CBT has minimal side effects other than mental discomfort during the exposure sessions. For safety concerns, pregnant women and subjects with seizure-related history will be excluded as well as other indicated conditions in the details protocol.
- Conditions
- Obsessive Compulsive Disorder (OCD)
- Keywords
- Transcranial magnetic stimulation (TMS), Cognitive behavioral therapy (CBT)
- Medical subject headings
- Obsessive-Compulsive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive behavioral therapyBehavioural
| Study group | Role | What they receive |
|---|---|---|
| rTMS and Cognitive Behavior Therapy | Experimental | Not described Receives: Device: Transcranial magnetic stimulation; Behavioral: Cognitive behavioral therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Remission Rate, as Measured by Y-BOCS
Remission is defined as end-point Yale-Brown Obsessive Compulsive Scale (Y-BOCS) score less than the value of 16.
Measured: 6 weeks
Secondary outcomes (3)
Complete Response, as Measured by Y-BOCS
Complete response is defined as a reduction of Y-BOCS score greater than 35%.
Measured: 6 weeks
Partial Response Rate, as Measured by Y-BOCS
Partial response is defined as a reduction of greater than 25%.
Measured: 6 weeks
Percentage of Adverse Events
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2015 (estimated)
- Study startMar 2016
- Primary completionJul 2016
- Study completionAug 2016
Why it stopped: PI has left Duke
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Obsessive Compulsive Disorder (OCD)Studies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- 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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Richard Weiner, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02528331
- Sponsor's protocol ID
- Pro00047168
- Acronym
- CBT-TMS
- Status last verified
- Nov 2016
- First submitted
- 17 Aug 2015
- Last updated
- 9 Feb 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Behavioral Strategies and Transcranial Magnetic Stimulation in Obsessive-Compulsive Disorder: Open Label Study
- ClinicalTrials.gov ID
- NCT02528331
- Acronym / sponsor ID
- CBT-TMS / Pro00047168
- Conditions
- Obsessive Compulsive Disorder (OCD)
- Keywords
- Transcranial magnetic stimulation (TMS), Cognitive behavioral therapy (CBT)
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: PI has left Duke
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- Jul 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 19 Aug 2015 (estimated)
- Results
- Posted 9 Feb 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the effectiveness of repetitive TMS (rTMS) delivered simultaneously with elements of cognitive behavioral therapy/exposure-response prevention (CBT/ERP) in adult subjects (greater or equal to 18 years old) with obsessive-compulsive disorder (OCD). This is an open label study that involves standard of care for OCD (CBT) and an investigational treatment modality (TMS). The investigators will compare the Yale-Brown Obsessive Compulsive Scale (YBOCS) scores before and after treatment to quantify clinical improvement. The side effects from TMS include, but are not limited to, headache, seizure, and general pain. CBT has minimal side effects other than mental discomfort during the exposure sessions. For safety concerns, pregnant women and subjects with seizure-related history will be excluded as well as other indicated conditions in the details protocol.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| rTMS and Cognitive Behavior Therapy | Experimental | Device: Transcranial magnetic stimulation, Behavioral: Cognitive behavioral therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subjects must meet all of the following inclusion criteria to qualify for enrollment into the study:
- All subjects will be 18 - 65 years of age.
- Obsessive-compulsive disorder:
- Subjects are willing and able to adhere to the intensive treatment schedule and all required study visits.
Key exclusion criteria (27 listed)
- Subjects will be excluded from study participation if one of the following exclusion criteria applies:
- Subjects are unable or unwilling to give informed consent.
- No exclusion criteria for comorbid DSM diagnosis.
- Subjects with a clinically defined neurological disorder that caused significant safety concern to receive TMS treatment, including, but not limited to:
- Subjects with any of the following treatment histories:
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 magnetic stimulation | Device | rTMS and Cognitive Behavior Therapy |
| Cognitive behavioral therapy | Behavioural | rTMS and Cognitive Behavior Therapy |
Primary outcome
Remission Rate, as Measured by Y-BOCS
Time frame: 6 weeks
Remission is defined as end-point Yale-Brown Obsessive Compulsive Scale (Y-BOCS) score less than the value of 16.
3 secondary outcomes
Complete Response, as Measured by Y-BOCS
Time frame: 6 weeks
Partial Response Rate, as Measured by Y-BOCS
Time frame: 6 weeks
Percentage of Adverse Events
Time frame: 6 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Richard Weiner, MD principal investigator
Duke University
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 magnetic stimulation and Cognitive behavioral therapy in people with Obsessive Compulsive Disorder (OCD), run by Duke University 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 6 inclusion and 27 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: stopped early, as of the sponsor's last update on 9 Feb 2017. 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?
Yes. Results are posted in the registry (first posted 9 Feb 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Remission Rate, as Measured by Y-BOCS (time frame: 6 weeks). 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 9 Feb 2017.