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

• Sponsor: Duke University (Other)
• Overall Status: Terminated
• CT.gov ID: NCT02528331
• Collaborator: (none)
• Enrollment: 2
• Location: 1
• Arm: 1
• Duration (Months): 5
• Patients Per Site Per Month: 0.4

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Obsessive Compulsive Disorder (OCD)	Device: Transcranial magnetic stimulation; Behavioral: Cognitive behavioral therapy	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 2 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Official Title: Cognitive Behavioral Strategies and Transcranial Magnetic Stimulation in Obsessive-Compulsive Disorder: Open Label Study
• Study Start Date: Mar 1, 2016
• Actual Primary Completion Date: Jul 1, 2016
• Actual Study Completion Date: Aug 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: rTMS and Cognitive Behavior Therapy	Device: Transcranial magnetic stimulation; Behavioral: Cognitive behavioral therapy

Outcome Measures

Primary Outcome Measures

1. Remission Rate, as Measured by Y-BOCS [6 weeks]

   Remission is defined as end-point Yale-Brown Obsessive Compulsive Scale (Y-BOCS) score less than the value of 16.

Secondary Outcome Measures

1. Complete Response, as Measured by Y-BOCS [6 weeks]

   Complete response is defined as a reduction of Y-BOCS score greater than 35%.

2. Partial Response Rate, as Measured by Y-BOCS [6 weeks]

   Partial response is defined as a reduction of greater than 25%.

3. Percentage of Adverse Events [6 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

1. 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).

1. 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

1. 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.

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Duke University Medical Center	Durham	North Carolina	United States	27705

Sponsors and Collaborators

• Duke University

Investigators

• Principal Investigator: Richard Weiner, MD, Duke University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Duke University
• ClinicalTrials.gov Identifier: NCT02528331
• Other Study ID Numbers: Pro00047168
• First Posted: Aug 19, 2015
• Last Update Posted: Feb 9, 2017
• Last Verified: Nov 1, 2016

• Keywords provided by Duke University: Transcranial magnetic stimulation (TMS); Cognitive behavioral therapy (CBT)
• Additional relevant MeSH terms: Compulsive Personality Disorder; Obsessive-Compulsive Disorder

Study Results

Participant Flow

Arm/Group Title	rTMS and Cognitive Behavior Therapy
Arm/Group Description	Transcranial magnetic stimulation Cognitive behavioral therapy
Period Title: Overall Study
STARTED	2
COMPLETED	0
NOT COMPLETED	2

Baseline Characteristics

Arm/Group Title	rTMS and Cognitive Behavior Therapy
Arm/Group Description	Transcranial magnetic stimulation Cognitive behavioral therapy
Overall Participants	2
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	2 100%
>=65 years	0 0%
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]	51.5
Gender (Count of Participants)
Female	1 50%
Male	1 50%
Region of Enrollment (participants) [Number]
United States	2 100%

Outcome Measures

1. Primary Outcome

Title	Remission Rate, as Measured by Y-BOCS
Description	Remission is defined as end-point Yale-Brown Obsessive Compulsive Scale (Y-BOCS) score less than the value of 16.
Time Frame	6 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	rTMS and Cognitive Behavior Therapy
Arm/Group Description	Transcranial magnetic stimulation Cognitive behavioral therapy
Measure Participants	2
Number [percentage of participants]	50 2500%

2. Secondary Outcome

Title	Complete Response, as Measured by Y-BOCS
Description	Complete response is defined as a reduction of Y-BOCS score greater than 35%.
Time Frame	6 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	rTMS and Cognitive Behavior Therapy
Arm/Group Description	Transcranial magnetic stimulation Cognitive behavioral therapy
Measure Participants	2
Number [percentage of participants]	50 2500%

3. Secondary Outcome

Title	Partial Response Rate, as Measured by Y-BOCS
Description	Partial response is defined as a reduction of greater than 25%.
Time Frame	6 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	rTMS and Cognitive Behavior Therapy
Arm/Group Description	Transcranial magnetic stimulation Cognitive behavioral therapy
Measure Participants	2
Number [percentage of participants]	50 2500%

4. Secondary Outcome

Title	Percentage of Adverse Events
Time Frame	6 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	rTMS and Cognitive Behavior Therapy
Arm/Group Description	Transcranial magnetic stimulation Cognitive behavioral therapy
Measure Participants	2
Number [percentage of adverse events]	0

Adverse Events

Arm/Group Title	rTMS and Cognitive Behavior Therapy
Arm/Group Description	Transcranial magnetic stimulation Cognitive behavioral therapy
All Cause Mortality
	rTMS and Cognitive Behavior Therapy
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	rTMS and Cognitive Behavior Therapy
	Affected / at Risk (%)	# Events
Total	0/2 (0%)
Other (Not Including Serious) Adverse Events
	rTMS and Cognitive Behavior Therapy
	Affected / at Risk (%)	# Events
Total	0/2 (0%)

Limitations/Caveats

This trial was terminated early leading to small numbers of subjects analyzed.

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.