Deep Brain Stimulation for Altered Level of Consciousness

Overseen By Samuel B Snider, MD

Age: 18 - 65

Sex: Any

Trial Phase: Phase < 1

Sponsor: Samuel Snider, MD

Must not be taking: Anticoagulants, Antiplatelets

Disqualifiers: Pregnancy, Neurodegenerative disorder, others

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

Compensation: Varies

Number of Visits: Unknown

2 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores deep brain stimulation (DBS) to determine its potential benefits for individuals with chronic disorders of consciousness, such as those in a minimally conscious state or unresponsive wakefulness syndrome. The study evaluates the safety, feasibility, and effectiveness of using electrical impulses on specific brain areas to enhance awareness and interaction. Participants will undergo both active and no-stimulation phases to compare effects. Ideal candidates have experienced a brain injury, such as from a stroke or accident, at least three months prior and are unable to interact meaningfully every day. As an Early Phase 1 trial, this research seeks to understand how the treatment functions in people, offering participants a chance to be among the first to receive this innovative therapy.

Will I have to stop taking my current medications?

The trial requires that you stop taking anticoagulant or anti-platelet medications for more than 2.5 weeks around the time of the surgery. If you are on these medications and cannot safely stop them, you may not be eligible to participate.

What prior data suggests that deep brain stimulation is safe for patients with chronic disorders of consciousness?

Research has shown that deep brain stimulation (DBS) can be safe for patients, including those with consciousness disorders. A large study tested DBS on older patients, and most tolerated it well, experiencing no serious side effects during the procedure. However, complications can occur, particularly around the time of surgery.

Regarding effectiveness, approximately 32.4% of patients showed improved consciousness levels one year after receiving DBS. While there is no conclusive evidence that DBS can fully restore consciousness and communication in all patients, it has produced positive effects in some cases.

In summary, DBS is generally well-tolerated but carries risks. Prospective trial participants should consider these factors and consult their healthcare provider for personalized advice. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatment?

Researchers are excited about deep brain stimulation (DBS) for altered levels of consciousness because it offers a novel approach, directly targeting specific areas of the brain believed to be crucial for wakefulness and awareness. Unlike conventional treatments that primarily focus on managing symptoms with medications or supportive care, DBS actively modulates brain activity. This is done through electrical impulses aimed at precise thalamic targets, which may restore or enhance consciousness in a more direct and potentially effective way. This treatment could open new possibilities for individuals with severe consciousness impairments, offering hope for improved outcomes.

What evidence suggests that deep brain stimulation is effective for chronic disorders of consciousness?

Research has shown that deep brain stimulation (DBS) can improve awareness in some patients with long-term consciousness disorders. In one study, 32.4% of patients experienced better awareness after a year of DBS treatment. Another study found that some patients progressed from being barely aware to fully aware following DBS. However, not all studies agree, and no clear proof exists that DBS can completely restore awareness and communication for everyone. Early results are promising, but more research is needed to confirm these findings. Participants in this trial will receive either active stimulation or no stimulation to further investigate these effects. ^{3 6 7 8 9}

Are You a Good Fit for This Trial?

The RECONNECT study is for patients with chronic disorders of consciousness, such as those in a coma or with an altered level of awareness due to brain injury. Specific eligibility details are not provided.

Inclusion Criteria

Participant must have a documented health care proxy or court-appointed guardian

Neurologist and neurosurgeon consensus review of most recent clinical MRI or CT determines no bilateral subcortical injury preventing precise electrode placement

Participant does not exhibit meaningful interaction or functional object use daily

Exclusion Criteria

Pregnant

Contraindication to brain MRI

Primary residence outside the Greater Boston metropolitan area

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

4 weeks

Surgical Implantation and Recovery

Implantation of DBS electrodes and recovery period

4 weeks

Blinded Stimulation

Participants undergo a 10-month blinded stimulation phase with alternating real and sham stimulation

40 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Deep brain stimulation (DBS)

Trial Overview This trial tests the safety and effectiveness of implanting deep brain stimulation (DBS) electrodes at two different spots within the central thalamus to possibly improve consciousness levels in affected patients.

How Is the Trial Designed?

Group I: active stimulation Experimental Treatment 1 Intervention

Each participant will receive a pre-determined sequence of active stimulation to one of two targets or no stimulation over the course of 10 months. This will be divided into two blocks (each with STIM and OFF periods) targeting each of the two thalamic targets. The order will be reversed in participant 2 relative to participant 1.

Group II: no stimulation Placebo Group 1 Intervention

periods of no active stimulation intermixed with active stimulation to one of two targets.

Who Is Running the Clinical Trial?

Samuel Snider, MD

Lead Sponsor

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10647871/

Long-term functional outcomes improved with deep brain ... In this study, we found an overall improvement in consciousness at 1 year was achieved in 32.4% (12/37) of the DBS group compared with 4.3% (14/ ...

2. nature.com nature.com/articles/s41598-023-46300-y

Deep brain stimulation in disorders of consciousness The level of consciousness was improved in seven patients. Three out of five MCS patients emerged to full awareness, with the ability to ...

3. mmrjournal.biomedcentral.com mmrjournal.biomedcentral.com/articles/10.1186/s40779-024-00585-w

a multidisciplinary review of advancements in deep brain ... [32] revealed that 37 patients undergoing bilateral monopolar stimulation at 100 Hz achieved a 32.4% improvement of consciousness within 1 year, ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1935861X17308860

Deep brain stimulation for disorders of consciousness There is no clear clinical evidence that DBS is a treatment for DoC that can restore both consciousness and the ability to communicate.

5. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/cns.14559

Clinical neuromodulatory effects of deep brain stimulation ... This graphical abstract provides an overview of the article, focusing on the clinical neuromodulatory effects of Deep Brain Stimulation ...

6. svn.bmj.com svn.bmj.com/content/early/2023/03/06/svn-2022-001998

Long-term functional outcomes improved with deep brain ... In this study, we found an overall improvement in consciousness at 1 year was achieved in 32.4% (12/37) of the DBS group compared with 4.3% (14/ ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11163193/

Clinical neuromodulatory effects of deep brain stimulation in ... The overall clinical efficacy rate in all included studies was 39.7%, indicating a positive effect of DBS in a subset of DOC patients.

8. clinicaltrials.gov clinicaltrials.gov/study/NCT06896279

NCT06896279 | Study on the Effectiveness and Safety of ... Study Overview. Investigating the efficacy and safety of temporal interference stimulation for patients with disorders of consciousness. Based on the central ...

9. thejns.org thejns.org/view/journals/j-neurosurg/135/5/article-p1421.xml

Perioperative complications of deep brain stimulation among ... In Brief. This is a large, single-institution study evaluating the safety of deep brain stimulation (DBS) in patients 75 years old or older. ...