Cognitive Behavioral Strategies and Transcranial Magnetic Stimulation in Obsessive-Compulsive Disorder: Open Label Study

Obsessive Compulsive Disorder (OCD) Clinical Trial

— CBT-TMS  

Official title:

Cognitive Behavioral Strategies and Transcranial Magnetic Stimulation in Obsessive-Compulsive Disorder: Open Label Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02528331
• Other study ID #: Pro00047168
• Status: Recruiting
• Phase: N/A
• First received: August 17, 2015
• Last updated: May 24, 2016
• Start date: March 2016
• Est. completion date: July 2016

Study information

• Verified date: March 2016
• Source: Duke University
• Contact: Yupei Hu, MD, MPH
• Phone: 919-681-2918
• Email: yupei.hu[@]duke.edu
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical 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). 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria

Subjects must meet all of the following inclusion criteria to qualify for enrollment into the study:

1. All subjects will be 18 - 65 years of age.

2. Obsessive-compulsive disorder:

• Subjects will meet the DSM-IV primary diagnosis of obsessive-compulsive

• Y-BOCS total score > 16

3. Subjects are willing and able to adhere to the intensive treatment schedule and all required study visits.

Exclusion Criteria

Subjects will be excluded from study participation if one of the following exclusion criteria applies:

1. Subjects are unable or unwilling to give informed consent.

2. No exclusion criteria for comorbid DSM diagnosis.

3. 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.

• 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).

4. 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

5. 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.

6. Women who are currently pregnant or not using a medically acceptable means of birth control and women who are breastfeeding.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Compulsive Behavior
• Obsessive Compulsive Disorder (OCD)
• Obsessive-Compulsive Disorder

Intervention

Device:
• Transcranial magnetic stimulation

Behavioral:
• Cognitive behavioral therapy

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	6 weeks	No
Secondary	Complete response, as measured by Y-BOCS	Complete response is defined as a reduction of Y-BOCS score greater than 35%.	6 weeks	No
Secondary	Partial response rate, as measured by Y-BOCS	Partial response is defined as a reduction of greater than 25%.	6 weeks	No