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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how deep brain stimulation (DBS) affects decision-making in individuals with epilepsy, severe depression, or obsessive-compulsive disorder (OCD). The researchers aim to understand how electrical stimulation in the brain influences choices between rewards and risks. The study includes two groups: one with the stimulation turned on and another with it off, to observe behavioral differences. Suitable candidates for this trial have had a deep brain stimulator implanted for at least three months or have a current diagnosis of severe depression or OCD. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research and potentially improve future treatments.

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 prior data suggests that Deep Brain Stimulation is safe for neurological and psychiatric conditions?

Research has shown that deep brain stimulation (DBS) often treats neurological conditions like Parkinson's disease. It also shows promise in managing symptoms and improving quality of life for certain mental health disorders. However, like any medical procedure, it carries some risks.

Studies have found that some patients may experience complications such as brain bleeding, infections, or issues with wire placement. There is also a small chance of stroke or breathing problems. Specifically, brain bleeding occurs in about 0.8% of patients, and infections happen in around 10.2% of cases. There is a 2.5% chance of suicide, and some patients might experience new or worsening depression.

While these risks may sound concerning, DBS has been successfully used in many patients worldwide for various conditions. Discussing these risks and potential benefits with a healthcare professional is crucial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Deep Brain Stimulation (DBS) because it offers a novel approach to treating neurological and psychiatric conditions by directly targeting specific brain areas. Unlike medications that adjust chemical levels throughout the brain, DBS provides precise electrical stimulation, which can potentially offer more immediate and tailored symptom relief. This technique allows for dynamic adjustments, offering a customizable treatment that can address individual patient needs more effectively than conventional drug therapies.

What evidence suggests that Deep Brain Stimulation is effective for neurological and psychiatric conditions?

Research has shown that Deep Brain Stimulation (DBS) can help treat various brain and mental health disorders. This trial will assess participants with DBS either turned on or off to evaluate its effects on reward motivation behavior. Studies have found that DBS can reduce symptoms like tremors and movement problems in Parkinson's disease by about 25%. It also effectively manages difficult-to-treat mental health conditions, improving the quality of life for many people. DBS works by adjusting specific brain circuits to relieve symptoms. Overall, DBS offers significant hope for improving mental and movement-related issues. ^{1 2 6 7 8}

Who Is on the Research Team?

Darin Dougherty, MD

Principal Investigator

Massachusetts General Hospital

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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) 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 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) 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 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 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]

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]

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]

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]

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]

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 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]

Citations

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Deep Brain Stimulation in Neurological and Psychiatric ... Multiple randomized controlled trials (RCTs) have shown that DBS improves tremor, dyskinesia, and quality of life in patients with Parkinson's disease by 25% to ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S2667049625000274

Review Deep brain stimulation in neuropsychiatric disorders DBS proves effective in refractory neuropsychiatric disorders, modulating specific symptoms and improving quality of life. Methodological ...

3. thelancet.com thelancet.com/journals/eclinm/article/PIIS2589-5370(24)00625-4/fulltext

Efficacy of brain stimulation therapies across psychiatric, ... Brain stimulation therapy (BST) has significant potential in treating psychiatric, movement, and cognitive disorders.

4. jneurosci.org jneurosci.org/content/43/45/7575

Advances in Deep Brain Stimulation: From Mechanisms to ... DBS is an effective treatment for various neurologic and neuropsychiatric disorders. The FDA has approved DBS in the treatment of Parkinson's ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6397644/

Deep brain stimulation: current challenges and future directions This Review considers how DBS has facilitated advances in our understanding of how circuit malfunction can lead to brain disorders and outlines the key unmet ...

6. mayoclinic.org mayoclinic.org/tests-procedures/deep-brain-stimulation/about/pac-20384562

Deep brain stimulation Surgery risks · Misplacement of the wires with the electrodes, known as leads. · Bleeding in the brain. · Stroke. · Infection. · Trouble breathing.

7. journals.plos.org journals.plos.org/plosone/article?id=10.1371/journal.pone.0178984

Adverse events in deep brain stimulation: A retrospective long ... In PD 23.1% of the STN-stimulated patients experienced non-reversible (or unknown reversibility) AEs that were at least possibly related to DBS in the form of ...

8. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38511957/

Adverse Effects of Deep Brain Stimulation for Treatment ... Hemorrhages occurred in 0.8% of patients and infections in 10.2%. The rate of completed suicide was 2.5%. Development or worsening of depressive ...