Deep-brain Stimulation in Obsessive-compulsive Disorder: Randomized, Double-blinded Clinical Trial (10/131)

July 13, 2017 updated by: Juan Antonio Barcia Albacar, Hospital San Carlos, Madrid

Deep-brain Stimulation in Obsessive-compulsive Disorder

A prospective, randomized, double-blinded study was conducted in 7 OCD patients during which 4 electrode contacts along a striatal axis were stimulated bilaterally. DBS electrode implantation followed a trajectory placing contact zero in nucleus accumbens (a common target for OCD treatment) with more proximal contacts placed in striatal segments defined using projections from prefrontal cortex subdivisions (ventromedial, orbitofrontal, dorsolateral) and anterior cingulate cortex.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Patients Seven patients, three men; aged 21-50 years; average (std) 36.67 (±14.64), and four women; aged 28-46 years; average: 35.25 (±8.14), suffering from treatment-refractory obsessive compulsive disorder participated in this study. All patients scored 30 or higher in the Yale-Brown Obsessive-Compulsive Scale (Y-BOCS). They were considered as candidates to DBS for OCD by two independent psychiatrists. An independent psychiatric surgery committee composed of one neurosurgeon, one psychiatrist and one legal medicine expert agreed surgery indication was appropriate. All patients provided written informed consent. The study had approval from the Hospital Clínico San Carlos ethics committee.

Pre-surgical Neuroimaging Before surgery, all patients underwent 3T Siemens TRIO system (Siemens, Erlangen, Germany) MRI scanning. Patients also performed an OCD symptom provocation task during fMRI scanning using modified version of the MOCSS (Maudsley Obsessive-Compulsive Stimuli Set). During scanning, patients were presented with pictures of 4 classes of provocative stimuli, 50 of each type: 1) contamination/washing, 2) checking, 3) hoarding, 4) symmetry/order. The study comprised 4 'blocks' pertaining to the 4 classes of provocative stimuli. Each block consisted of ten 20-s alternating epochs in which subjects viewed either 10 provocative or 10 neutral pictures (see Supplementary material for a full description). Post-operative computed tomography (CT) scanning was used to determine correct electrode positioning.

Neurosurgical procedure The target was selected for the distal electrode contact (contact zero) to be placed at the NAcc close to the bed nucleus of the stria terminalis: 1.5 mm rostral to the anterior border of the anterior commissure, 4 mm ventral to the AC-PC line and 7 mm lateral to the mid-sagittal plane. Then, the striatum was segmented using the deterministic DTI projections of the three subdivisions of the prefrontal cortex (ventromedial vmPFC, orbitofrontal OFC, dorsolateral DLPFC) plus the anterior cingulate cortex (ACC). A trajectory was planned for placing the rest of the contacts of a Medtronic Model 3391 stimulating macroelectrode at several points along the striatum avoiding the ventricles in such a way that each of the electrode contacts (contacts 1, 2, and 3) was closest to each segment of the striatum corresponding to OFC, DLPFC and ACC.

Deep-Brain Stimulation Protocol After surgery, a random sequence of contact activations (0 [Nacc],1,2 and 3), including sham (-), was generated for each patient. Each contact was activated using 130 Hz, 60 ms, and 4.5 V for three months (the sham activation was 0 V) following the patient's individual sequence, separated by one month of washout with the generator turned off

The study meets a double-blind, longitudinal design. Stimulation contact was set following a random series known only by the neurosurgeon, with patient, psychiatry and neuropsychology teams blind. Psychiatric assessment was conducted each month, and neuropsychological testing was performed after each activation and washout period

Symptom-provocation fMRI analysis Functional imaging data were analyzed using statistical parametric mapping (SPM12; http://www.fil.ion.ucl.ac.uk/spm) employing an epoch-related model. The main symptom(s) for each patient was defined and used to construct a contrast of responses to provocation vs. neutral pictures. The ensuing contrasts were masked with an inclusive prefrontal mask and the statistical parametric map thresholded at P < 0.001 uncorrected. Cluster extent was defined using AlphaSIM (threshold P < 0.05). Note that due to weak responses during symptom activation in patients 4 and 6, the SPMs for these patients were first thresholded at P < 0.01 and 0.005 uncorrected, respectively. After the clinical protocol had ended, the projections to the cortical activated areas on the MOCSS for each patient in their main symptomatic dimension from the striatum were calculated using probabilistic tractography. The connectivity between each of the contacts and the fMRI activations was calculated as the number of fibers of the projection of each contact (sphere of diameter 4 mm around the contact) to the cortical activated areas.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
7

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

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.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients suffering from treatment-refractory obsessive compulsive disorder
  • Scored 30 or higher in the Yale-Brown Obsessive-Compulsive Scale (Y-BOCS)
  • Considered as candidates to DBS for OCD by two independent psychiatrists.
  • An independent psychiatric surgery committee composed of one neurosurgeon, one psychiatrist and one legal medicine expert agreed surgery indication was appropriate
  • Provide written informed consent.

Exclusion Criteria:

  • Any concomitant neurological or psychiatric condition
  • Any surgical contraindication

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Interventional Model: SEQUENTIAL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Deep Brain stimulation
After the surgery, a random sequence of contact activations (0 [Nacc],1,2 and 3), including sham (-), was generated for each patient. Each contact was activated using 130 Hz, 60 ms, and 4.5 V for three months (the sham activation was 0 V) following the patient's individual sequence, separated by one month of washout with the generator turned off
Device: Deep Brain stimulation
Electrical stimulation at subcortical level
Other Names:
  • Medtronic lead

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Yale-Brown Obsessive-Compulsive Scale
Time Frame: 2 years
OCD symptoms scale
2 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Emotion
Time Frame: 2 years
Depresion and anxiety scores
2 years

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Neuropsychology
Time Frame: 2 years
Neuropsychological scales (A battery of tests, covering the main cognitive domains, was created to assess neuropsychological changes).
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hospital San Carlos, Madrid

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Juan A Barcia, MD PhD, Hospital San Carlos

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2011

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2014

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 12, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 12, 2017

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 13, 2017

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 18, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 13, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 10/131

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

They will appear in the public report

IPD Sharing Time Frame

2017-2018

IPD Sharing Supporting Information Type

  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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