RECRUITING

SEEG-Guided DBS for OCD

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This is a multi-site, double-blinded, randomized, crossover study design for SEEG-guided 4-lead DBS for treatment-refractory OCD, followed by open label stimulation for an additional 6 months. The study will be conducted in 3 stages: Stage 1 will consist of SEEG brain mapping and optimization of stimulation parameters. Stage 2 will consist of DBS surgery and further optimization of stimulation parameters. Stage 3 will be randomized, crossover treatment, followed by open label treatment.

Official Title

A Double-Blinded, Randomized, Crossover Trial of Stereoencephalography- Guided Multi-Lead Deep Brain Stimulation for Treatment-Refractory Obsessive- Compulsive Disorder (SEEG-Guided DBS for OCD)

Quick Facts

Study Start:2023-04-13

Study Completion:2027-01-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05623306

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:22 Years to 75 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. ≥ 22 years and ≤ 75 years of age, at the time of screening 2. Chronic (\> 5 years preceding the date of enrollment) OCD, diagnosed as per the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition guidelines (DSM-5) 1. Presence of obsessions, compulsions, or both 2. Time-consuming obsessions and compulsions that take more than one hour a day or cause clinically significant distress or impairment in social, occupational, or other important areas of functioning 3. Obsessive-compulsive symptoms that are not attributable to the physiological effects of a substance (e.g. a drug of abuse, a medication) or another medical condition 4. Disturbance not better explained by the symptoms of another mental disorder listed in the DSM-5 3. Severe OCD symptoms, as defined by Y-BOCS I score of ≥ 28, within two weeks prior to enrollment 4. Lack of adequate response to a history of the following treatments, based on information from any of the following: (a) the current treating physician and/or psychologist; (b) medical records or other forms of communication from previous healthcare providers; and (c) pharmacy records, as determined by the Principal Investigator 1. Adequate trial of ≥ 2 selective serotonin reuptake inhibitors (SSRIs) for an adequate duration at the maximum dose recommended for OCD or at the maximally-tolerated dose according to the FDA-approved package labeling 2. Adequate trial of ≥ 1 augmentation trial using an antipsychotic medication 3. Adequate trial of clomipramine, either as monotherapy or as an augmentation therapy, unless medically contradicted 4. Adequate trials of cognitive behavior therapy-based Exposure and Response Prevention (ERP) 5. Willingness and ability to remain on the same daily dose of any and all scheduled psychotropic medication(s) for at least 8 weeks prior to study enrollment and for the duration of the trial, in the opinion of the Principal Investigator 6. Willingness and ability to discontinue any psychotherapeutic behavioral intervention therapy (e.g. CBT) until the maintenance stage, if determined safe by the research/study psychiatrist 7. Study participation in the prospective subject's best psychiatric interest, as determined by the research/study psychiatrist and based on a comprehensive assessment that includes the following: (a) detailed psychiatric history; (b) examination of the mental status; (c) review of psychiatric assessment measures obtained to determine eligibility, as applicable; (d) review of previous medical records for a minimum of 2 years prior to enrollment, or as applicable; and (e) consideration of the potential benefits versus risks of study participation 8. Agreement to being evaluated by a licensed psychiatrist and/or psychologist at regular intervals, as required by the schedule of events, for the duration of study participation 9. Living within 6 hours of driving distance from study sites and no plan of relocation for at least the duration of the trial (approximately 18-24 months), as reported by the prospective subject or a family member 10. Adequate social support, including but not limited to, stable housing and two family members and/or friends, who are identified as a verifiable emergency contacts 11. Willingness and ability to provide at least two verifiable contacts for emergency purposes and to permit verification of emergency contacts by research staff before all study visits and as needed, at the discretion of the Principal Investigator 12. Ability to understand procedure-related instructions and to complete study assessments in English, in the opinion of the Principal Investigator 13. Willingness and ability to comply with protocol requirements (e.g. procedure visits, treatment schedule, follow-up visit schedule, evaluations, etc.), in the opinion of the Principal Investigator 14. Willingness and ability to provide written agreement to allow any and all forms of communication between the research team and treating clinician(s) 15. Willingness and ability to provide informed consent, in the opinion of the Principal Investigator	1. Diagnosis of, according to the Mini International Neuropsychiatric Interview (MINI), any other primary psychiatric diagnosis defined in the DSM-5, including Hoarding Disorder. 2. In the opinion of the Principal Investigator and relative to the date of enrollment, (a) current or past diagnosis of, or medical history/records suggestive of, a DSM-5 defined Personality Disorder, considered to be severe; or (b) history of hospitalization because of Borderline Personality Disorder 3. Clinical secondary diagnosis made by a psychiatrist, as defined in the DSM-5 and based on the MINI and the psychiatric evaluation: 1. Lifetime diagnosis of Bipolar I Disorder or Bipolar II Disorder 2. Current/active diagnosis of Anorexia Nervosa, Bulimia Nervosa, or Binge Eating Disorder 4. Current suicidal risk, as determined by the research/study psychiatrist using the brief mental status exam and the psychiatric interview (including the Columbia Suicide Severity Rating Scale \[C-SSRS\]), or significant suicide risk, defined as Hamilton Depression Rating Scale (HDRS-21) Item 3 score of ≥ 3 or any lifetime history of suicide attempt 5. Treatment, within 24 months of screening, for any of the following: dependency on, addiction to, use of, abuse of, or overuse of any illicit substance(s), including alcohol, but not including nicotine or caffeine 6. History of head trauma associated with any of the following: 1. Loss of consciousness for \> 5 minutes 2. A residual effect(s) that failed to resolve completely at least 1 year prior to the date of screening 3. An abnormality on a neuroimaging study (MRI, CT Scan) that was/is attributable to the head trauma 4. \> 1 head injury within the past 2 years which were diagnosed as a concussion, concussive-type or traumatic brain injury (TBI), according to medical records or as reported by the prospective subject or a family member 7. Any of the following permanent implants: 1. Cardiac implant (e.g. pacemaker or any intracardiac lines, implanted neurostimulators, shunts) 2. Brain implant (e.g. intracranial implant, aneurysm clips, shunts, stimulators, cochlear implants, or electrodes) 3. Implanted medical pumps 8. Diathermy treatments requirement for any reason 9. Hearing loss that, in the opinion of the Principal Investigator, an audiologist, or a treating physician, is likely to affect the subject's ability to comply with all of the requirements of the study or may affect the integrity of the study data 10. Any metal or metallic particles anywhere in the head, except in the inside of the mouth 11. Pregnancy, at the time of screening or during the course of the study (i.e. 3 years) 12. History of involuntary movements, in the opinion of the Principal Investigator or a neuro-radiologist 13. History of excessive or prolonged bleeding and/or any of the following: 1. INR of \> 1.8 2. Prolonged activated partial thromboplastin time (aPTT) of ≥ 45 sec 3. Platelet count of \< 75×100/L 14. Allergy to gadolinium 15. Inability to safely and successfully undergo an MRI or a CT Scan 16. Any past or present medical condition, disease, disorder, or injury that, in the opinion of the Principal Investigator, may reduce or hinder the subject's ability to fully comply with all study requirements for the duration of the study or may impact, compromise, or affect the integrity of the data or the results of the study 17. Current participation in other research that may potentially interfere with DBS study objectives or with the ability to follow the timeline of this study, as determined by the Principal Investigator

Inclusion Criteria

Exclusion Criteria

1. ≥ 22 years and ≤ 75 years of age, at the time of screening
2. Chronic (\> 5 years preceding the date of enrollment) OCD, diagnosed as per the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition guidelines (DSM-5)
1. Presence of obsessions, compulsions, or both
2. Time-consuming obsessions and compulsions that take more than one hour a day or cause clinically significant distress or impairment in social, occupational, or other important areas of functioning
3. Obsessive-compulsive symptoms that are not attributable to the physiological effects of a substance (e.g. a drug of abuse, a medication) or another medical condition
4. Disturbance not better explained by the symptoms of another mental disorder listed in the DSM-5
3. Severe OCD symptoms, as defined by Y-BOCS I score of ≥ 28, within two weeks prior to enrollment
4. Lack of adequate response to a history of the following treatments, based on information from any of the following: (a) the current treating physician and/or psychologist; (b) medical records or other forms of communication from previous healthcare providers; and (c) pharmacy records, as determined by the Principal Investigator
1. Adequate trial of ≥ 2 selective serotonin reuptake inhibitors (SSRIs) for an adequate duration at the maximum dose recommended for OCD or at the maximally-tolerated dose according to the FDA-approved package labeling
2. Adequate trial of ≥ 1 augmentation trial using an antipsychotic medication
3. Adequate trial of clomipramine, either as monotherapy or as an augmentation therapy, unless medically contradicted
4. Adequate trials of cognitive behavior therapy-based Exposure and Response Prevention (ERP)
5. Willingness and ability to remain on the same daily dose of any and all scheduled psychotropic medication(s) for at least 8 weeks prior to study enrollment and for the duration of the trial, in the opinion of the Principal Investigator
6. Willingness and ability to discontinue any psychotherapeutic behavioral intervention therapy (e.g. CBT) until the maintenance stage, if determined safe by the research/study psychiatrist
7. Study participation in the prospective subject's best psychiatric interest, as determined by the research/study psychiatrist and based on a comprehensive assessment that includes the following: (a) detailed psychiatric history; (b) examination of the mental status; (c) review of psychiatric assessment measures obtained to determine eligibility, as applicable; (d) review of previous medical records for a minimum of 2 years prior to enrollment, or as applicable; and (e) consideration of the potential benefits versus risks of study participation
8. Agreement to being evaluated by a licensed psychiatrist and/or psychologist at regular intervals, as required by the schedule of events, for the duration of study participation
9. Living within 6 hours of driving distance from study sites and no plan of relocation for at least the duration of the trial (approximately 18-24 months), as reported by the prospective subject or a family member
10. Adequate social support, including but not limited to, stable housing and two family members and/or friends, who are identified as a verifiable emergency contacts
11. Willingness and ability to provide at least two verifiable contacts for emergency purposes and to permit verification of emergency contacts by research staff before all study visits and as needed, at the discretion of the Principal Investigator
12. Ability to understand procedure-related instructions and to complete study assessments in English, in the opinion of the Principal Investigator
13. Willingness and ability to comply with protocol requirements (e.g. procedure visits, treatment schedule, follow-up visit schedule, evaluations, etc.), in the opinion of the Principal Investigator
14. Willingness and ability to provide written agreement to allow any and all forms of communication between the research team and treating clinician(s)
15. Willingness and ability to provide informed consent, in the opinion of the Principal Investigator

1. Diagnosis of, according to the Mini International Neuropsychiatric Interview (MINI), any other primary psychiatric diagnosis defined in the DSM-5, including Hoarding Disorder.
2. In the opinion of the Principal Investigator and relative to the date of enrollment, (a) current or past diagnosis of, or medical history/records suggestive of, a DSM-5 defined Personality Disorder, considered to be severe; or (b) history of hospitalization because of Borderline Personality Disorder
3. Clinical secondary diagnosis made by a psychiatrist, as defined in the DSM-5 and based on the MINI and the psychiatric evaluation:
1. Lifetime diagnosis of Bipolar I Disorder or Bipolar II Disorder
2. Current/active diagnosis of Anorexia Nervosa, Bulimia Nervosa, or Binge Eating Disorder
4. Current suicidal risk, as determined by the research/study psychiatrist using the brief mental status exam and the psychiatric interview (including the Columbia Suicide Severity Rating Scale \[C-SSRS\]), or significant suicide risk, defined as Hamilton Depression Rating Scale (HDRS-21) Item 3 score of ≥ 3 or any lifetime history of suicide attempt
5. Treatment, within 24 months of screening, for any of the following: dependency on, addiction to, use of, abuse of, or overuse of any illicit substance(s), including alcohol, but not including nicotine or caffeine
6. History of head trauma associated with any of the following:
1. Loss of consciousness for \> 5 minutes
2. A residual effect(s) that failed to resolve completely at least 1 year prior to the date of screening
3. An abnormality on a neuroimaging study (MRI, CT Scan) that was/is attributable to the head trauma
4. \> 1 head injury within the past 2 years which were diagnosed as a concussion, concussive-type or traumatic brain injury (TBI), according to medical records or as reported by the prospective subject or a family member
7. Any of the following permanent implants:
1. Cardiac implant (e.g. pacemaker or any intracardiac lines, implanted neurostimulators, shunts)
2. Brain implant (e.g. intracranial implant, aneurysm clips, shunts, stimulators, cochlear implants, or electrodes)
3. Implanted medical pumps
8. Diathermy treatments requirement for any reason
9. Hearing loss that, in the opinion of the Principal Investigator, an audiologist, or a treating physician, is likely to affect the subject's ability to comply with all of the requirements of the study or may affect the integrity of the study data
10. Any metal or metallic particles anywhere in the head, except in the inside of the mouth
11. Pregnancy, at the time of screening or during the course of the study (i.e. 3 years)
12. History of involuntary movements, in the opinion of the Principal Investigator or a neuro-radiologist
13. History of excessive or prolonged bleeding and/or any of the following:
1. INR of \> 1.8
2. Prolonged activated partial thromboplastin time (aPTT) of ≥ 45 sec
3. Platelet count of \< 75×100/L
14. Allergy to gadolinium
15. Inability to safely and successfully undergo an MRI or a CT Scan
16. Any past or present medical condition, disease, disorder, or injury that, in the opinion of the Principal Investigator, may reduce or hinder the subject's ability to fully comply with all study requirements for the duration of the study or may impact, compromise, or affect the integrity of the data or the results of the study
17. Current participation in other research that may potentially interfere with DBS study objectives or with the ability to follow the timeline of this study, as determined by the Principal Investigator

Contacts and Locations

Study Contact

Nida Firdous, MD, MS

CONTACT

2158296720

nida.firdous@pennmedicine.upenn.edu

Giovanna Rocchio

CONTACT

2158296720

Giovanna.Rocchio@Pennmedicine.upenn.edu

Study Locations (Sites)

Stanford University

Stanford, California, 94304

United States

University of Pennsylvania

Philadelphia, Pennsylvania, 19106

United States

Collaborators and Investigators

Sponsor: Casey H. Halpern, M.D.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-04-13

Study Completion Date2027-01-01

Study Record Updates

Study Start Date2023-04-13

Study Completion Date2027-01-01

Terms related to this study

Additional Relevant MeSH Terms

Obsessive-Compulsive Disorder