Deep Brain Stimulation for Neurological and Psychiatric Conditions
Recruiting in Palo Alto (17 mi)
+1 other location
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Massachusetts General Hospital
Disqualifiers: Bipolar, Psychotic disorder, Substance abuse, others
No Placebo Group
Approved in 2 Jurisdictions
Trial Summary
What is the purpose of this trial?We propose to study approach/avoidance behavior as measured by the Approach Avoidance task in 20 epilepsy patients undergoing implementation of depth electrodes for seizure monitoring in the Epilepsy Monitoring Unit at MGH. We will also study the effects of VC/VS electrical stimulation on approach-avoidance conflict in 20 adult patients who have undergone DBS implantation for severe MDD and/or OCD. There are 100-200 patients in the world with DBS electrodes in the VC/VS, and our research team cares for more than any other institution. Both participant groups will be assessed with respect to reward-aversion decision conflict using the task. The task will be performed with concurrent EEG recordings in DBS patients, and with continuous recording through our invasive neurophysiology rig in EMU subjects.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the treatment Deep Brain Stimulation for neurological and psychiatric conditions?
Deep Brain Stimulation (DBS) has shown promising results in treating conditions like obsessive-compulsive disorder and major depressive disorder, especially in patients who do not respond to other treatments. Studies indicate that about half of the patients with treatment-resistant psychiatric disorders experience improvement with DBS.
12345Is Deep Brain Stimulation generally safe for humans?
Deep Brain Stimulation (DBS) is generally considered safe, but it can have some risks like infection (2-9%), bleeding in the brain (1-4%), and seizures (1-3%). Rarely, it can cause serious issues like an abscess in the brain.
678910How is the treatment Deep Brain Stimulation (DBS) different from other treatments for neurological and psychiatric conditions?
Deep Brain Stimulation (DBS) is unique because it involves implanting electrodes in the brain to deliver electrical pulses to specific areas, which can help manage conditions like Parkinson's disease, epilepsy, and certain psychiatric disorders when other treatments have failed. Unlike medications, DBS directly targets brain activity and is used for patients who do not respond to standard therapies.
24111213Eligibility Criteria
This trial is for epilepsy patients with depth electrodes and adults with severe Major Depressive Disorder (MDD) or Obsessive-Compulsive Disorder (OCD) who have a deep brain stimulator implanted. Participants must be right-handed, have normal vision and hearing, and not suffer from bipolar disorder, psychosis, brain damage, cognitive impairments affecting consent ability, recent substance abuse, severe personality disorders or dementia.Inclusion Criteria
You are right-handed, have normal vision and hearing, and do not have a current diagnosis of major depressive disorder (MDD) or obsessive-compulsive disorder (OCD).
DBS Patients: Deep brain stimulator implantation performed at least three months prior to study
Exclusion Criteria
You have a condition that prevents you from seeing the objects used in the study even with corrective measures, or have dementia or other cognitive impairments.
I do not have severe mental health issues that would affect my participation.
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants undergo the Approach Avoidance task with DBS ON and OFF, including EEG recordings and task performance
8-16 hours
1-2 visits (in-person)
Follow-up
Participants are monitored for any adverse effects and overall safety after the task
4 weeks
Participant Groups
The study examines how electrical stimulation from Deep Brain Stimulators affects decision-making related to reward and aversion in patients. It involves performing tasks while undergoing EEG recordings for those with DBS implants for MDD/OCD and continuous recording in epilepsy monitoring unit subjects.
2Treatment groups
Active Control
Group I: Deep Brain Stimulation OnActive Control1 Intervention
We will assess Reward Motivation behavior with Deep Brain Stimulation on.
Group II: Deep Brain Stimulation OffActive Control1 Intervention
We will assess Reward Motivation behavior with Deep Brain Stimulation off.
Deep Brain Stimulator is already approved in United States, European Union for the following indications:
🇺🇸 Approved in United States as Medtronic DBS System for Epilepsy for:
- Focal epilepsy in adults who have not achieved seizure control after trying three or more epilepsy medications
🇪🇺 Approved in European Union as Deep Brain Stimulation for:
- Epilepsy
- Parkinson's disease
- Essential tremor
- Dystonia
- Obsessive-compulsive disorder
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Massachusetts General HospitalBoston, MA
Massachusetts General HospitalCharlestown, MA
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Who Is Running the Clinical Trial?
Massachusetts General HospitalLead Sponsor
References
Electrodes in the brain--ethical criteria for research and treatment with deep brain stimulation for neuropsychiatric disorders. [2022]Deep brain stimulation (DBS) has been used for neuropsychiatric disorders in clinical and research settings for almost 50 years now. Recent evidence demonstrates some efficacy in treating obsessive-compulsive disorder and major depression in patients refractory to other treatment modalities beyond single case reports. This has led to a considerable surge of clinical and commercial interest in DBS for psychiatric indications. Because of the high vulnerability of psychiatric patients, the lack of extensive short- and long-term data about effectiveness and the rapid spread of questionable indications this new field in psychiatry requires ethical criteria that can be applied to both research and clinical decision-making.
Deep Brain Stimulation in Neurological and Psychiatric Disorders. [2018]Deep brain stimulation (DBS) is the chronic electrical stimulation of selected target sites in the brain through stereotactically implanted electrodes. More than 150 000 patients around the world have been treated to date with DBS for medically intractable conditions. The indications for DBS include movement disorders, epilepsy, and some types of mental illness.
A systematic review of psychiatric indications for deep brain stimulation, with focus on major depressive and obsessive-compulsive disorder. [2022]Deep brain stimulation is a treatment under investigation for a range of psychiatric disorders. It has shown promising results for therapy-refractory obsessive-compulsive disorder (OCD) and major depressive disorder (MDD). Other indications under investigation include Tourette's syndrome, anorexia nervosa and substance use disorders.
[Deep brain stimulation for psychiatric disorders]. [2018]Deep brain stimulation (DBS) is a treatment using implanted electrodes to deliver electrical pulses to targeted areas of the brain. DBS holds great promise in psychiatry for the treatment of patients with treatment-resistant obsessive-compulsive disorder, depression and Gilles de la Tourette syndrome. Double-blind and open trials have shown that the treatment is effective in about half of these patients. Further research should focus on optimizing DBS with respect to target location for the various psychiatric disorders. More controlled double-blind trials are needed to corroborate the effectiveness of DBS in patients with psychiatric disorders.
[Deep brain stimulation in the surgical management of major depressive disorder and obsessive-compulsive disorder]. [2015]Despite significant advances in psychopharmacology, many patients with psychiatric disorders remain severely impaired by their conditions in their private, professional and social lives. Deep brain stimulation (DBS) is a proven method of surgical management of Parkinson's disease, dystonia and essential tremor. Electrodes implanted in deep brain structures have a direct neuromodulatory effect on neuronal structures responsible not only for movement disorders but also for psychiatric disorders. The stereotactic targets for psychiatric disorders include limbic parts of the nuclei of the limbic neuronal loop. At present, DBS is applied to treat medically refractory obsessive-compulsive disorder, depression and Tourette syndrome in small groups of patients. This overview includes the rationale for the use of DBS in psychiatric disorders, a summary of preliminary research done to date, and a discussion of achieved results.
Intracerebral abscess: a rare complication of Deep Brain Stimulation. [2013]Deep Brain Stimulation (DBS) is a therapeutic option for some forms of Parkinson's disease (PD). The main adverse effects of this surgery are: infection (2-9%), haemorrhage (1-4%) and seizures (1-3%). We report a rare complication of DBS: an intracranial abscess.
Complications of deep brain stimulation in Parkinson's disease: a single-center experience of 517 consecutive cases. [2023]The number of deep brain stimulation (DBS) procedures is rapidly rising as well as the novel indications. Reporting adverse events related to surgery and to the hardware used is essential to define the risk-to-benefit ratio and develop novel strategies to improve it.
Systematic review of hardware-related complications of Deep Brain Stimulation: Do new indications pose an increased risk? [2022]Deep Brain Stimulation (DBS) is an effective treatment extended broadly to many neurological and psychiatric disorders. Nevertheless, complications may arise during DBS procedures or following implantation due to implanted hardware. This may result in both minor and major adverse events that may necessitate hardware removal and/or compromise maximal therapeutic benefit for the patient.
Surgical and Hardware-Related Adverse Events of Deep Brain Stimulation: A Ten-Year Single-Center Experience. [2022]Although deep brain stimulation (DBS) is effective for treating a number of neurological and psychiatric indications, surgical and hardware-related adverse events (AEs) can occur that affect quality of life. This study aimed to give an overview of the nature and frequency of those AEs in our center and to describe the way they were managed. Furthermore, an attempt was made at identifying possible risk factors for AEs to inform possible future preventive measures.
Administration of electroconvulsive therapy for depression associated with deep brain stimulation in a patient with post-traumatic Parkinson's Disease: a case study. [2018]Deep brain stimulation (DBS) has been shown to be effective for parkinsonian symptoms poorly responsive to medications. DBS is typically well-tolerated, as are the maintenance battery changes. Here we describe an adverse event during a battery replacement procedure that caused rapid onset of severe depression.
Deep brain stimulation for psychiatric disorders. [2018]Deep brain stimulation (DBS), an established treatment for some movement disorders, is now being used experimentally to treat psychiatric disorders as well. In a number of recently published case series, DBS yielded an impressive therapeutic benefit in patients with medically intractable psychiatric diseases.
Directions of Deep Brain Stimulation for Epilepsy and Parkinson's Disease. [2022]Deep brain stimulation (DBS) is an effective treatment for movement disorders and neurological/psychiatric disorders. DBS has been approved for the control of Parkinson disease (PD) and epilepsy.
Deep brain stimulation: current and emerging indications. [2008]Deep brain stimulation (DBS) has been used to treat a number of neurological and psychiatric diseases. Initially applied to chronic pain, DBS today is routinely used to treat movement disorders, predominantly Parkinson's Disease, essential tremor, and dystonia. Recent studies have demonstrated potential for treating depression and obsessive-compulsive disorder.