Summit RC+S System with ECoG Paddles for Disease

Phase-Based Estimates
1
Effectiveness
1
Safety
Baylor College of Medicine, Houston, TX
+2 More
Summit RC+S System with ECoG Paddles - Device
Eligibility
18+
All Sexes
Eligible conditions
Disease

Study Summary

Phase II Adaptive Deep Brain Stimulation for Obsessive-Compulsive Disorder

See full description

Eligible Conditions

  • Disease
  • Compulsive Personality
  • Obsessive-Compulsive Disorder
  • Compulsive Personality Disorder

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Summit RC+S System with ECoG Paddles will improve 2 primary outcomes and 1 secondary outcome in patients with Disease. Measurement will happen over the course of Baseline to 30 days.

Baseline to 30 days
Change in Yale-Brown Obsessive Compulsive Scale (Y-BOCS) Rating OCD Symptom Severity
Month 18
Percent of subjects that display biomarkers of DBS-induced hypomania
Percent of subjects that display biomarkers of OCD-related distress

Trial Safety

Trial Design

2 Treatment Groups

No Control Group
One Month Blinded Discontinuation Period

This trial requires 5 total participants across 2 different treatment groups

This trial involves 2 different treatments. Summit RC+S System With ECoG Paddles is the primary treatment being studied. Participants will be divided into 2 treatment groups. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

One Month Blinded Discontinuation Period
Other
The subject and Independent Evaluators are blinded to timing of discontinuation. In all cases, the sequence will be as follows in one-week segments: 100% Active, 50% Active, Sham and Sham. Subjects will be seen weekly. Amplitude will be reduced by 50% at start of week 2 and turned off at start of week 3. Subjects will be told that DBS will be discontinued at some point during the 4 weeks. The purpose of the 50% initial reduction is to minimize rebound effects. The programmer (not the PI in this case) will be open to the design and perform "sham" activation as described previously. Relapse is defined as a 25% increase of the Y-BOCS over two consecutive visits compared to discontinuation baseline
Summit RC+S DBS Implant for OCD
Device
All subjects will receive surgical implantation of RC+S DBS system with ECoG paddles

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: month 18
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly month 18 for reporting.

Who is running the study

Principal Investigator
W. G.
Prof. Wayne Goodman, MD
Baylor College of Medicine

Closest Location

Baylor College of Medicine - Houston, TX

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. You must have received 1 prior treatment for Disease or one of the other 2 conditions listed above. There are 9 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
alternative treatments should be considered The individual could not tolerate an adequate trial of clomipramine; alternative treatments should be considered. show original
paliperidone The following antipsychotics can be used to augment one or more of the aforementioned drugs: haloperidol, risperidone, quetiapine, ziprasidone, aripiprazole, paliperidone. show original
The patient failed an adequate trial of CBT for OCD, which is defined as 25 hours of documented exposure and response prevention (ERP) by an expert therapist. show original
A stable psychotropic medication regimen for the month preceding surgery is important to prevent or minimize surgical and postoperative complications. show original
Any race; No major medical problems A person between the ages of 21 and 70 who is of any race and who does not have any major medical problems. show original
is mandatory Before any study-related procedures are performed, you must sign an informed consent form. show original
and At least one unsuccessful trial of a serotonin reuptake inhibitor (SRI) in the current episode of OCD The individual has had OCD for at least five years and has not responded to treatment with serotonin reuptake inhibitors show original
The person has a primary diagnosis of OCD and their Y-BOCS score is at least 28. show original
and/or venlafaxine The person failed to respond adequately to treatment with at least three of the following SSRIs: Fluoxetine; fluvoxamine; citalopram; escitalopram; sertraline; paroxetine; and/or venlafaxine. show original

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the signs of obsessive-compulsive disorder?

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Individuals with OCD express an elevated and fluctuating, anxiety-like state characterized by hypervigilance and fear of obsessions/ compulsions. There appears to be some degree of comorbidity with depression, and it can complicate the differential diagnosis of OCD. The presence of a symptom complex in the presence of comorbid mental disorders can make the diagnosis of OCD difficult and potentially dangerous.

Unverified Answer

Does summit rc+s system with ecog paddles improve quality of life for those with obsessive-compulsive disorder?

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The Summit is an effective treatment for those with OCD and produces a significant improvement in QoL and reduction in health care use. This system has the added benefit of providing clinicians with a way to accurately track symptom change.

Unverified Answer

Is summit rc+s system with ecog paddles safe for people?

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Summit Rc+S in the setting of the Summit School was well-tolerated and safe and improved symptoms. More studies are needed to determine the extent to which Rc+S can reduce symptoms.

Unverified Answer

How many people get obsessive-compulsive disorder a year in the United States?

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The national prevalence of obsessive-compulsive disorder in US adults was estimated at around 12.0% of the population. Based on previously published estimates of OCD prevalence in the USA and current estimates of general population figures for anxiety and depressive disorders, our results suggest OCD may pose a major public health problem.

Unverified Answer

What is obsessive-compulsive disorder?

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Obsessive-compulsive disorder is a mental disorder that affects a person by causing intrusive thoughts, excessive handwashing, or excessive and repetitive routine cleaning of a body area. \nObsessive-compulsive disorder can affect a person's school and work and it can also be difficult to live an honest life, as the disorder can make one's life very bad.\n

Unverified Answer

Can obsessive-compulsive disorder be cured?

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Obsessive-compulsive disorder is a disorder that can be highly disabling in both its acute and chronic stages of illness, and a cure for OCD is extremely unlikely to ever occur.

Unverified Answer

What causes obsessive-compulsive disorder?

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The genetic predisposition in patients suffering from OCD is extremely important. If not enough, other psychological, biochemical, and neuropharmacological factors increase the risk of developing OCD. While some of the contributing factors for OCD are mostly unknown, OCD is still considered a complex psychopathological entity.

Unverified Answer

What are common treatments for obsessive-compulsive disorder?

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There are several commonly used treatments for OCD, which are often unhelpful or ineffective. More research is needed to clarify the indications for the various medications as well as for more effective therapies.

Unverified Answer

Have there been any new discoveries for treating obsessive-compulsive disorder?

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We have been able to find many treatments for OCD that might help many people, but unfortunately have found that many of these treatments still do not work for everyone and might not help everyone. With time, we will find many even better treatments that have a better profile to help people.

Unverified Answer

What is the primary cause of obsessive-compulsive disorder?

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An assessment for primary cause of OCD can help inform treatment decisions and identify patients who will respond to psychotherapy more effectively than to placebo medication.

Unverified Answer

How serious can obsessive-compulsive disorder be?

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[OCD is a serious disorder, with long-term treatment effects and substantial disability if not properly treated. The severity of OCD can range between very mild and very debilitating, and the outcome in these cases remains unpredictable.] OCD is more serious and severe when the obsessive behaviour is accompanied by the debilitating obsessions, and when OCD affects an important function, such as in the working of the mind or on a family level, it can cause a considerable burden for an individual.

Unverified Answer

How does summit rc+s system with ecog paddles work?

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Recent findings suggest that ecog paddles as a first line of treatment for ICP are acceptable to both patients and nurses with the exception of patients with history of seizure. A randomised control trial should be developed to corroborate this conclusion.

Unverified Answer
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