Deep Brain Stimulation for Stroke

Overseen By Elvira Pirondini, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Jorge Gonzalez-Martinez

Must not be taking: Anticoagulants, Anti-spasticity, Anti-epileptic, others

Disqualifiers: Neurological condition, Cancer, Cardiac, others

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

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 29 days

10 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if deep brain stimulation (DBS) of the motor thalamus can improve hand, arm, and speech functions in individuals who have experienced a stroke. DBS involves a surgical procedure where electrodes are placed in the brain and connected to external devices to test movements and speech. The trial targets those who had a single stroke over six months ago and now struggle with speech clarity or motor skills. Participants should not have other serious health issues or require medications that might interfere with the study. This research could lead to new treatments that enhance independence and quality of life for stroke survivors. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could transform stroke recovery.

Will I have to stop taking my current medications?

Participants must not be on anti-spasticity or anti-epileptic medications during the study. If you are taking these, you will need to stop. The protocol does not specify about other medications, so it's best to discuss with the study team.

What prior data suggests that this deep brain stimulation technique is safe for stroke patients?

Research has shown that deep brain stimulation (DBS) can be a safe and effective treatment for individuals with movement problems following a stroke. A review of DBS for these issues found it could help many patients safely. Another study involving 12 people with severe movement problems after a stroke also supported that DBS is safe and feasible.

Researchers in these studies carefully noted any side effects. Although surgery always carries some risk, these findings suggest that DBS is generally well-tolerated. This is encouraging for those considering DBS as part of their recovery. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Deep Brain Stimulation (DBS) for stroke recovery because it offers a new approach by directly targeting the motor thalamus in the brain. Unlike traditional therapies that often rely on rehabilitation exercises to improve motor and speech functions, DBS uses electrical impulses to stimulate brain activity, potentially leading to faster and more significant improvements. This method could provide new hope for patients with persistent deficits following a stroke, as it works by enhancing neural pathways that are crucial for motor control and speech, something current treatments don't address as directly.

What evidence suggests that deep brain stimulation is effective for improving motor and speech functions after a stroke?

Research has shown that deep brain stimulation (DBS) of the motor thalamus can improve movement and speech after a stroke. In one study, 82% of participants experienced at least a 30% improvement after one year. Another study found that DBS helped with speech and swallowing for those with speech difficulties. This trial will evaluate DBS of the motor thalamus for individuals with speech and motor deficits due to a stroke. These findings suggest that DBS could restore abilities and enhance the quality of life for stroke survivors. ^{1 3 4 6 7}

Who Is on the Research Team?

Jorge Gonzalez-Martinez, MD/PhD

Principal Investigator

University of Pittsburgh

Are You a Good Fit for This Trial?

This trial is for individuals who have had a subcortical stroke and are experiencing difficulties with speech and arm/hand movements. Candidates must be stable after their stroke and able to give informed consent. Specific details about age, time since stroke, or other health conditions that might affect eligibility are not provided.

Inclusion Criteria

Native English speaker

I had a stroke over 6 months ago and now have speech difficulties.

I have moderate to severe difficulty speaking clearly.

Exclusion Criteria

Patients who cannot undergo pre-operative MRIs or could not complete the pre-operative assessments

I am mentally capable of understanding and signing a consent form.

I am not taking any blood thinners.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgical Procedure

Participants undergo a surgical procedure to implant deep brain stimulation electrode leads

1 week

Treatment

Participants receive deep brain stimulation to assess motor and speech function improvements

29 days

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) of the Motor Thalamus

Trial Overview

The study tests if deep brain stimulation (DBS) of the motor thalamus can help restore speech and upper limb function in post-stroke patients. Participants will undergo surgery to implant electrodes for less than 30 days, during which the effects on movement and speech will be assessed.

How Is the Trial Designed?

Group I: Deep Brain Stimulation of the Motor Thalamus Experimental Treatment 1 Intervention

Individuals who have speech and motor deficits due to a stroke.

Deep Brain Stimulation (DBS) of the Motor Thalamus is already approved in European Union, United States, Canada, Japan for the following indications:

Approved in European Union as Deep Brain Stimulation (DBS) for:

• Parkinson's disease
• Essential tremor
• Dystonia
• Chronic pain
• Obsessive-compulsive disorder
• Treatment-resistant depression

Approved in United States as Deep Brain Stimulation (DBS) for:

• Parkinson's disease
• Essential tremor
• Dystonia
• Obsessive-compulsive disorder
• Epilepsy

Approved in Canada as Deep Brain Stimulation (DBS) for:

• Parkinson's disease
• Essential tremor
• Dystonia

Approved in Japan as Deep Brain Stimulation (DBS) for:

• Parkinson's disease
• Essential tremor

Who Is Running the Clinical Trial?

Jorge Gonzalez-Martinez

Lead Sponsor

Trials

1

Recruited

10+

Published Research Related to This Trial

Unilateral deep brain stimulation (DBS) of the VIM nucleus in the thalamus shows long-term efficacy in reducing essential tremor symptoms, with significant improvements noted in tremor scores at an average follow-up of 40.2 months after surgery.

While the treatment is effective for some patients, it is associated with device-related complications and a risk of loss of efficacy over time, necessitating additional surgical interventions in some cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term safety and efficacy of unilateral deep brain stimulation of the thalamus in essential tremor. Koller, WC., Lyons, KE., Wilkinson, SB., et al.[2022]

In a 5-year follow-up study of 38 patients with essential tremor (ET) and Parkinson's disease (PD), thalamic deep brain stimulation (DBS) showed significant long-term efficacy, with patients experiencing up to 100% improvement in tremors depending on the type of stimulation (unilateral or bilateral).

While DBS is generally safe, common adverse effects included paresthesia and pain for unilateral implants, and dysarthria and balance difficulties for bilateral implants, indicating that careful consideration is needed when opting for bilateral stimulation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term evaluation of deep brain stimulation of the thalamus. Pahwa, R., Lyons, KE., Wilkinson, SB., et al.[2022]

A case of hyperhidrosis (excessive sweating) was observed as a side effect of a misplaced deep brain stimulation (DBS) electrode in a patient with essential tremor, highlighting a potential complication of DBS procedures.

The MRI revealed that the electrode was incorrectly placed near the hypothalamus, suggesting that high-frequency stimulation may activate sympathetic pathways, leading to hypothalamic dysfunction as a rare but significant side effect.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hyperhidrosis due to deep brain stimulation in a patient with essential tremor. Case report. Diamond, A., Kenney, C., Almaguer, M., et al.[2022]

In a patient with MS-related tremor, simultaneous stimulation of multiple thalamic targets (V.im. and V.o.a.) did not provide additional benefits compared to stimulating each target individually, indicating that more complex stimulation may not always lead to better outcomes.

For a patient with poststroke Holmes' tremor, stimulation of the globus pallidus internus (Gpi) was effective in reducing tremors, suggesting that targeting this area can be a viable alternative to thalamic stimulation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multiple target deep brain stimulation for multiple sclerosis related and poststroke Holmes' tremor. Lim, DA., Khandhar, SM., Heath, S., et al.[2022]

In a study of 46 patients treated with VIM deep brain stimulation (DBS) for essential tremor, 70% reported high satisfaction with the treatment, with a median score of 10 out of 10 for overall satisfaction and a significant long-term effect on tremor reduction.

The study found no significant increase in mortality among VIM-DBS patients compared to the general population, with a standard mortality ratio of 1.3, although one patient did commit suicide, raising questions about potential suicide risk associated with the procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term follow-up of thalamic deep brain stimulation for essential tremor - patient satisfaction and mortality. Børretzen, MN., Bjerknes, S., Sæhle, T., et al.[2021]

Unilateral deep brain stimulation (DBS) of the thalamus significantly improved tremor scores in patients with Parkinson's disease over a long-term follow-up period averaging 40 months, demonstrating its efficacy for treating medication-resistant tremor.

While there were some mild adverse effects, including two asymptomatic intracerebral hemorrhages, the overall safety profile was acceptable, with manageable stimulus-related reactions and necessary device replacements due to normal wear and tear.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long term safety and efficacy of unilateral deep brain stimulation of the thalamus for parkinsonian tremor. Lyons, KE., Koller, WC., Wilkinson, SB., et al.[2019]

Deep brain stimulation (DBS) of the ventral intermediate nucleus of the thalamus (VIM) significantly improves tremor and handwriting in patients with essential tremor, with an average tremor score reduction from 3.27 to 0.64 and handwriting score from 2.94 to 0.89 over an average follow-up of 56.9 months.

The treatment is considered safe, with an 80.4% improvement in tremor and 69.7% in handwriting, although some patients may experience tolerance requiring adjustments in stimulation parameters, and the overall hardware-related complication rate was 23.5%.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term results of thalamic deep brain stimulation for essential tremor. Zhang, K., Bhatia, S., Oh, MY., et al.[2022]

Deep brain stimulation of the anterior nuclei of the thalamus (ANT-DBS) has shown promising results in reducing seizure frequency in patients with focal epilepsy, with reductions of 41% at 1 year, 69% at 5 years, and 75% at 7 years.

While ANT-DBS can lead to non-serious adverse effects like depression and memory impairment, the long-term benefits in seizure control suggest it is a viable treatment option, although further large-scale studies are needed to optimize therapy and identify predictors of success.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Deep brain stimulation of the anterior nuclei of the thalamus in focal epilepsy. Deutschová, B., Rektor, I.[2023]

Deep brain stimulation (DBS) of the ventral intermediate (Vim) thalamic nucleus is an effective treatment for tremor disorders, particularly essential tremor and tremor-dominant Parkinson's disease.

There are technical variations in the surgical techniques used for Vim DBS, particularly in preoperative imaging and electrode trajectory planning, which can influence the procedure's effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Surgical Technique of Ventral Intermediate Thalamic Deep Brain Stimulation]. Morishita, T., Tanaka, H., Inoue, T.[2021]

Deep brain stimulation (DBS) of the thalamic ventral-intermediate nucleus (VIM) is a safe and effective treatment for tremors associated with multiple sclerosis (MS), showing up to 61% improvement in tremor scores at 6 months post-surgery in a study of 7 patients.

Patients experienced significant enhancements in their quality of life, with improvements ranging from 30% to 175% at 6 months, and these benefits were sustained for an average follow-up of 26.6 months, indicating long-term efficacy of the intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient selection and outcome of deep brain stimulation for multiple sclerosis-associated tremor. Paranathala, MP., Mills, R., Rai, P., et al.[2023]

Deep Brain Stimulation (DBS) in the ventral intermediate nucleus (VIM) of the thalamus effectively relieved tremor symptoms in all four patients with drug-resistant tremor, demonstrating significant tremor control.

The procedure was safe, with no serious adverse events reported; any transient adverse effects were quickly resolved by adjusting the stimulation parameters.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Deep brain stimulation of thalamus for tremor control]. Nasser, JA., Falavigna, A., Alaminos, A., et al.[2009]

An 18-year-old man with severe action tremor following a traumatic brain injury experienced significant tremor suppression after undergoing deep brain stimulation (DBS) targeting the left ventral intermediate nucleus of the thalamus.

The procedure was performed without complications, suggesting that DBS may be a safe and effective treatment option for managing intractable posttraumatic tremor.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Thalamic deep brain stimulation for posttraumatic action tremor. Umemura, A., Samadani, U., Jaggi, JL., et al.[2009]

High-frequency stimulation of the ventral intermediate nucleus (Vim) was effective in reducing tremor in 88% of patients with Parkinson's disease and essential tremor, with 27 out of 43 thalami showing complete relief and 11 showing major improvement.

The procedure demonstrated a favorable safety profile, with only mild adverse effects that could be managed by adjusting the stimulation, making it a preferable option over thalamotomy for bilateral treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term suppression of tremor by chronic stimulation of the ventral intermediate thalamic nucleus. Benabid, AL., Pollak, P., Gervason, C., et al.[2022]

In a study involving four patients with posttraumatic and multiple sclerosis tremors, the use of dual deep brain stimulation (DBS) electrodes targeting both the VIM and VOA/VOP thalamic regions resulted in significant improvements in tremor symptoms across all tested conditions, with no tremor rebound observed after chronic stimulation.

The combination of VIM and VOA/VOP DBS showed greater symptom reduction compared to using either electrode alone, suggesting that targeting multiple areas may enhance treatment efficacy for tremors that do not respond well to standard therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dual electrode thalamic deep brain stimulation for the treatment of posttraumatic and multiple sclerosis tremor. Foote, KD., Seignourel, P., Fernandez, HH., et al.[2006]

Citations

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clinicaltrials.gov

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11469375/

Targeted deep brain stimulation of the motor thalamus ...

Here we show that Deep Brain Stimulation (DBS) of the motor thalamus improved speech and swallowing functions in two participants with dysarthria and dysphagia.

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sciencedirect.com

sciencedirect.com/science/article/abs/pii/S1935861X17309361

Deep brain stimulation for stroke: Current uses and future ...

We conducted a comprehensive literature review in order to 1) review the use of DBS to treat post-stroke maladaptive responses including pain, dystonia, ...

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nature.com

nature.com/articles/s41591-023-02507-0

Cerebellar deep brain stimulation for chronic post-stroke ...

In this open-label, non-randomized phase I trial, we applied deep brain stimulation to the cerebellar dentate nucleus combined with renewed physical ...

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pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/36308482/

Deep brain stimulation for movement disorders after stroke

This review suggests that DBS for movement disorders after a stroke has the potential to be effective and safe for diverse patients.

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newsroom.clevelandclinic.org/2023/08/14/cleveland-clinic-study-shows-deep-brain-stimulation-encouraging-for-stroke-patients

Cleveland Clinic Study Shows Deep Brain Stimulation ...

Cleveland Clinic study shows deep brain stimulation encouraging for stroke patients. First in-human trial phase one results published in Nature Medicine.