Deep Brain Stimulation for Neurological and Psychiatric Conditions

Recruiting at 1 trial location

Overseen By Darin D Dougherty, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Massachusetts General Hospital

Disqualifiers: Bipolar, Psychotic disorder, Substance abuse, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 8-16 hours

60 Participants Needed

Trial Summary

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. ^{1 2 3 4 5}

Is 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. ^{6 7 8 9 10}

How 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. ^{2 4 11 12 13}

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.

Research Team

Darin Dougherty, MD

Principal Investigator

Massachusetts General Hospital

Eligibility 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.

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

Treatment Details

Interventions

• Deep Brain Stimulator
• ON/OFF Stimulation and Reward Motivation

Trial Overview 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.

Participant Groups

Group I: Deep Brain Stimulation On Active Control 1 Intervention

We will assess Reward Motivation behavior with Deep Brain Stimulation on.

Group II: Deep Brain Stimulation Off Active Control 1 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

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

Findings from Research

Deep brain stimulation (DBS) shows promise in treating severe cases of obsessive-compulsive disorder and major depression, particularly in patients who have not responded to other treatments, highlighting its potential efficacy in neuropsychiatric disorders.

The study emphasizes the need for ethical guidelines in the application of DBS for psychiatric conditions, focusing on principles like beneficence, nonmaleficence, and autonomy to ensure safe and responsible use in vulnerable patient populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electrodes in the brain--ethical criteria for research and treatment with deep brain stimulation for neuropsychiatric disorders. Synofzik, M., Schlaepfer, TE.[2022]

Deep brain stimulation (DBS) is an effective treatment for movement disorders, particularly Parkinson's disease, showing improvements in tremor, dyskinesia, and quality of life by 25% to 50% based on various rating scales.

While DBS has proven efficacy for neurological conditions, it has not shown significant benefits for psychiatric disorders, as evidenced by early termination of trials for depression due to lack of efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Deep Brain Stimulation in Neurological and Psychiatric Disorders. Coenen, VA., Amtage, F., Volkmann, J., et al.[2018]

Deep brain stimulation (DBS) has shown promise as a treatment for therapy-refractory obsessive-compulsive disorder (OCD) and major depressive disorder (MDD), with 286 patients studied across various trials.

While DBS for OCD has received FDA approval, the overall evidence for its efficacy in psychiatric disorders is limited due to small sample sizes and a lack of randomized controlled trials, making other indications still experimental.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review of psychiatric indications for deep brain stimulation, with focus on major depressive and obsessive-compulsive disorder. Naesström, M., Blomstedt, P., Bodlund, O.[2022]

Deep brain stimulation (DBS) has shown effectiveness in treating about 50% of patients with treatment-resistant psychiatric disorders such as obsessive-compulsive disorder, depression, and Gilles de la Tourette syndrome.

Further research is necessary to optimize DBS by identifying the best target locations in the brain for different disorders, and more controlled double-blind trials are needed to confirm its efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Deep brain stimulation for psychiatric disorders]. Overbeek, JM., de Koning, P., Luigjes, J., et al.[2018]

Deep brain stimulation (DBS) has shown promise as a surgical treatment for psychiatric disorders like obsessive-compulsive disorder, depression, and Tourette syndrome, particularly in patients who do not respond to traditional medications.

DBS works by implanting electrodes in specific brain areas, which can modulate neuronal activity, potentially improving symptoms in patients with severe psychiatric impairments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Deep brain stimulation in the surgical management of major depressive disorder and obsessive-compulsive disorder]. Sobstyl, M., Dzierzecki, S., Zabek, M.[2015]

Deep Brain Stimulation (DBS) for Parkinson's disease can lead to rare complications, such as an intracranial abscess, as demonstrated in a case involving a 59-year-old male who developed significant inflammation and required multiple surgeries after the procedure.

Despite the complications, the patient's Parkinson's symptoms improved after the abscess was surgically drained, suggesting that the abscess may have inadvertently provided some therapeutic benefit similar to a subthalomotomy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intracerebral abscess: a rare complication of Deep Brain Stimulation. Brandão, E., Rosas, MJ., Abreu, P., et al.[2013]

Deep brain stimulation (DBS) for Parkinson's disease is generally safe, with a low mortality rate of 0.2% and permanent morbidity at 0.6%, but complications such as intracerebral hemorrhage (ICH) and seizures can occur in a small percentage of cases.

The study found that the type of lead used in DBS can influence complications, with Medtronic's leads associated with higher rates of perielectrode brain edema compared to Boston Scientific's, highlighting the need for further research on hardware design to improve safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Complications of deep brain stimulation in Parkinson's disease: a single-center experience of 517 consecutive cases. Servello, D., Galbiati, TF., Iess, G., et al.[2023]

A systematic review of 96 studies found that the most common complications from Deep Brain Stimulation (DBS) procedures include infections (5.12% of patients) and lead migration (1.60%), highlighting the importance of monitoring for these issues post-surgery.

Patients with conditions like dystonia and off-label indications such as Tourette's syndrome are at a higher risk for hardware-related complications, suggesting that these patients should receive thorough pre-surgical counseling and close follow-up care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Systematic review of hardware-related complications of Deep Brain Stimulation: Do new indications pose an increased risk? Jitkritsadakul, O., Bhidayasiri, R., Kalia, SK., et al.[2022]

In a study of 200 patients undergoing deep brain stimulation (DBS) procedures over a follow-up period of approximately 43 months, 20% experienced surgical or hardware-related adverse events (AEs), but all resolved without permanent effects.

The most common AEs were surgical site infections (9.95%) and wire tethering (2.49%), indicating that while AEs can occur, major complications requiring further surgery are rare, highlighting the overall safety of DBS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Surgical and Hardware-Related Adverse Events of Deep Brain Stimulation: A Ten-Year Single-Center Experience. Bouwens van der Vlis, TAM., van de Veerdonk, MMGH., Ackermans, L., et al.[2022]

Deep brain stimulation (DBS) is effective for managing parkinsonian symptoms, but in rare cases, it can lead to severe mood disruptions, as demonstrated by a 58-year-old woman who developed rapid-onset depression during a routine battery replacement procedure after 5 years of DBS treatment.

Electroconvulsive therapy (ECT) proved to be an effective treatment for the patient's severe depression, highlighting its potential as a therapeutic option for patients experiencing intractable mood disorders related to DBS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Administration of electroconvulsive therapy for depression associated with deep brain stimulation in a patient with post-traumatic Parkinson's Disease: a case study. Cunningham, MG., Yadollahikhales, G., Vitaliano, G., et al.[2018]

Deep brain stimulation (DBS) has shown promising results in treating medically intractable psychiatric disorders, with symptom improvement ranging from 35% to 70% in some studies, although not all patients responded positively.

Adverse effects from DBS are rare and typically reversible by adjusting stimulation settings, indicating a favorable safety profile for this experimental treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Deep brain stimulation for psychiatric disorders. Kuhn, J., Gründler, TO., Lenartz, D., et al.[2018]

Deep brain stimulation (DBS) is an effective treatment for movement disorders like Parkinson's disease and epilepsy, with ongoing advancements in both open-loop and closed-loop systems.

Recent research is increasingly focusing on closed-loop DBS systems, which may offer improved outcomes by adapting stimulation based on real-time feedback from the patient's brain activity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Directions of Deep Brain Stimulation for Epilepsy and Parkinson's Disease. Wu, YC., Liao, YS., Yeh, WH., et al.[2022]

Deep brain stimulation (DBS) is an effective treatment for various neurological and psychiatric conditions, particularly movement disorders like Parkinson's Disease, essential tremor, and dystonia.

Recent research suggests that DBS may also be beneficial for treating mental health issues such as depression and obsessive-compulsive disorder, expanding its therapeutic potential.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Deep brain stimulation: current and emerging indications. Dowling, J.[2008]

References

1. United States pubmed.ncbi.nlm.nih.gov

Electrodes in the brain--ethical criteria for research and treatment with deep brain stimulation for neuropsychiatric disorders. [2022]

2. Germany pubmed.ncbi.nlm.nih.gov

Deep Brain Stimulation in Neurological and Psychiatric Disorders. [2018]

3. England pubmed.ncbi.nlm.nih.gov

A systematic review of psychiatric indications for deep brain stimulation, with focus on major depressive and obsessive-compulsive disorder. [2022]

4. Netherlands pubmed.ncbi.nlm.nih.gov

[Deep brain stimulation for psychiatric disorders]. [2018]

5. Poland pubmed.ncbi.nlm.nih.gov

[Deep brain stimulation in the surgical management of major depressive disorder and obsessive-compulsive disorder]. [2015]

6. Spain pubmed.ncbi.nlm.nih.gov

Intracerebral abscess: a rare complication of Deep Brain Stimulation. [2013]

7. Austria pubmed.ncbi.nlm.nih.gov

Complications of deep brain stimulation in Parkinson's disease: a single-center experience of 517 consecutive cases. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Systematic review of hardware-related complications of Deep Brain Stimulation: Do new indications pose an increased risk? [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Surgical and Hardware-Related Adverse Events of Deep Brain Stimulation: A Ten-Year Single-Center Experience. [2022]

10. England pubmed.ncbi.nlm.nih.gov

Administration of electroconvulsive therapy for depression associated with deep brain stimulation in a patient with post-traumatic Parkinson's Disease: a case study. [2018]

11. Germany pubmed.ncbi.nlm.nih.gov

Deep brain stimulation for psychiatric disorders. [2018]

12. Switzerland pubmed.ncbi.nlm.nih.gov

Directions of Deep Brain Stimulation for Epilepsy and Parkinson's Disease. [2022]

13. United States pubmed.ncbi.nlm.nih.gov

Deep brain stimulation: current and emerging indications. [2008]