Deep Brain Stimulation for Stroke
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Jorge Gonzalez-Martinez
Must not be taking: Anticoagulants, Anti-spasticity, Anti-epileptic, others
Disqualifiers: Neurological condition, Cancer, Cardiac, others
No Placebo Group
Approved in 4 Jurisdictions
Trial Summary
What is the purpose of this trial?The goal of this study is to verify whether the use of deep brain stimulation can improve motor function of the hand and arm and speech abilities for people following a stroke. Participants will undergo a surgical procedure to implant deep brain stimulation electrode leads. The electrodes will be connected to external stimulators and a series of experiments will be performed to identify the types of movements that the hand and arm can make and how speech abilities are affected by the stimulation. The implant will be removed after less than 30 days. Results of this study will provide the foundation for future studies evaluating the efficacy of a minimally-invasive neuro-technology that can be used in clinical neuro-rehabilitation programs to restore speech and upper limb motor functions in people with subcortical strokes, thereby increasing independence and quality of life.
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 data supports the effectiveness of the treatment Deep Brain Stimulation (DBS) of the Motor Thalamus for stroke?
Research shows that Deep Brain Stimulation (DBS) of the thalamus is effective in reducing tremors in conditions like essential tremor and Parkinson's disease, with many patients experiencing significant improvement. This suggests that DBS could potentially help manage symptoms in other conditions, such as stroke, by targeting similar brain areas.
12345Is deep brain stimulation of the thalamus generally safe for humans?
Deep brain stimulation (DBS) of the thalamus has been studied for conditions like Parkinson's disease and essential tremor. While it can improve symptoms, some patients experienced mild side effects that were manageable, and a few had more serious issues like brain bleeding or seizures. Device-related complications were common, sometimes requiring additional surgeries.
678910How is Deep Brain Stimulation (DBS) of the Motor Thalamus different from other treatments for stroke?
Deep Brain Stimulation (DBS) of the Motor Thalamus is unique because it involves implanting electrodes in the brain to send electrical impulses, which can help manage symptoms like tremors. Unlike medications, which are taken orally or injected, DBS directly targets brain areas involved in movement control, offering a different approach for conditions like stroke where traditional treatments may be limited.
211121314Eligibility Criteria
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
I am between 18 and 70 years old.
Native English speaker
I had a stroke over 6 months ago and now have speech difficulties.
+1 more
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.
+12 more
Trial Timeline
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
Participant Groups
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.
1Treatment groups
Experimental Treatment
Group I: Deep Brain Stimulation of the Motor ThalamusExperimental Treatment1 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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of PittsburghPittsburgh, PA
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Who Is Running the Clinical Trial?
Jorge Gonzalez-MartinezLead Sponsor
References
Long-term follow-up of thalamic deep brain stimulation for essential tremor - patient satisfaction and mortality. [2021]Ventral intermediate thalamic nucleus (VIM) deep brain stimulation (DBS) is an effective treatment for tremor, but there is limited data on long-term efficacy and mortality after VIM-DBS. Here we report the analysis of patient satisfaction and mortality in all patients treated in our center 1996-2010 with VIM-DBS for essential tremor (ET).
Dual electrode thalamic deep brain stimulation for the treatment of posttraumatic and multiple sclerosis tremor. [2006]To report the results of ventralis intermedius nucleus/ventralis oralis posterior nucleus (VIM) plus ventralis oralis anterior (VOA)/ventralis oralis posterior (VOP) thalamic deep brain stimulation (DBS) for the treatment of posttraumatic and multiple sclerosis tremor.
[Deep brain stimulation of thalamus for tremor control]. [2009]We present our results in 4 patients with tremor, in whom electrodes (uni and bilateral) for Deep Brain Stimulation (DBS) were implanted in the ventral intermediate nucleus (VIM) of the thalamus.
Thalamic deep brain stimulation for posttraumatic action tremor. [2009]We report a case of thalamic deep brain stimulation (DBS) for treatment of posttraumatic tremor. An 18-year-old right-handed man developed a disabling and medically refractory action tremor in the right upper extremity 9 months after sustaining diffuse axonal injury in a motor vehicle collision. DBS of the left ventral intermediate nucleus of the thalamus (Vim) suppressed the tremor without complication and should be considered as an option for the management of intractable posttraumatic tremor.
Long-term suppression of tremor by chronic stimulation of the ventral intermediate thalamic nucleus. [2022]The usefulness of high-frequency stimulation of the ventral intermediate nucleus (Vim) as the first neurosurgical procedure in disabling tremor was assessed in 26 patients with Parkinson's disease and 6 with essential tremor. 7 of these patients had already undergone thalamotomy contralateral to the stimulated side, and 11 others had bilateral Vim stimulation at the same time. Chronic stimulating electrodes connected to a pulse generator were implanted in the Vim. Tremor amplitude at rest, during posture holding, and during action and intention manoeuvres was assessed by means of accelerometry. Of the 43 thalami stimulated, 27 showed complete relief from tremor and 11 major improvement (88%). The improvement was maintained for up to 29 months (mean follow-up 13 [SD 9] months). Adverse effects were mild and could be eradicated by reduction or cessation of stimulation. This reversibility and adaptability, allowing control of side-effects, make thalamic stimulation preferable to thalamotomy, especially when treatment of both sides of the brain is needed.
Long term safety and efficacy of unilateral deep brain stimulation of the thalamus for parkinsonian tremor. [2019]The objective was to investigate the long term safety and efficacy of unilateral deep brain stimulation (DBS) of the VIM nucleus of the thalamus in Parkinson's disease. Twelve patients with Parkinson's disease underwent unilateral DBS of the thalamus for medication resistant tremor between 1994 and 1997. Patients were evaluated with the motor section of the unified Parkinson's disease rating scale (UPDRS) in the medication on state at baseline, 3 months, 12 months, and yearly thereafter.Three patients were lost to follow up. Nine patients had follow up evaluations greater than 24 months and were included in the analyses. The last postsurgical follow up occurred on average 40.0 (SD 17.2) months after surgery. Tremor scores were significantly improved with stimulation on at the long term follow up compared with baseline. There was no significant change in UPDRS motor scores at long term follow up compared with baseline. There was no significant change in any stimulus parameters from 3 months to the long term follow up. Two patients had asymptomatic intracerebral haemorrhages and one patient had a subcutaneous haematoma over the implantable pulse generator site. Stimulus related adverse reactions were mild and easily controlled with changes in stimulus parameters. Two patients had replacement of the implantable pulse generator due to normal battery depletion, one patient had lead repositioning due to migration, and one patient had the lead extension wire replaced due to erosion. In conclusion, unilateral DBS of the thalamus has long term efficacy for treatment of tremor due to Parkinson's disease.
Long-term safety and efficacy of unilateral deep brain stimulation of the thalamus in essential tremor. [2022]Our objective was to investigate the long-term safety and efficacy of unilateral deep brain stimulation (DBS) of the VIM nucleus of the thalamus in essential tremor. Forty-nine patients were evaluated for DBS between December 1993 and March 1998. Tremor was assessed by a clinical rating scale at 3 and 12 months and then yearly. Three patients were not implanted, seven were explanted prior to 24 months, 11 were lost to long-term follow-up, and three died from unrelated causes. Twenty-five patients were evaluated with follow-up greater than or equal to 2 years. The last postsurgical follow-up occurred on average 40.2 +/- 14.7 months after surgery. Tremor scores were significantly improved with stimulation on at the long-term follow-up as compared to baseline. There was no change in tremor scores from baseline to long-term follow-up with stimulation off. There was no significant change in any stimulus parameters from 3 months to the long-term follow-up. Three patients had asymptomatic intracerebral hemorrhages and one patient had postoperative seizures. Stimulus-related adverse reactions were mild and easily controlled with changes in stimulus parameters. Device-related complications were common and required repeated surgical procedures. Unilateral DBS of the thalamus has long-term efficacy in some patients for treatment of essential tremor. However, this therapy is compromised by loss of efficacy in some patients and device complications which increase the risk of additional surgical procedures.
Long-term evaluation of deep brain stimulation of the thalamus. [2022]The effects of thalamic deep brain stimulation (DBS) on essential tremor (ET) and Parkinson disease (PD) have been well documented, but there is a paucity of long-term data. The aim of this study was to evaluate the long-term safety and efficacy of DBS of the ventralis intermedius nucleus (VIM) of the thalamus for PD and ET.
Hyperhidrosis due to deep brain stimulation in a patient with essential tremor. Case report. [2022]The authors present a unique case of hyperhidrosis as a side effect of a misplaced deep brain stimulation (DBS) electrode near the ventrointermedius (Vim) nucleus in a patient with essential tremor. Magnetic resonance imaging of the brain showed electrode placement in the left anterior thalamus traversing the hypothalamus. High-frequency electrical stimulation possibly resulted in unilateral activation of the efferent sympathetic pathways in the zona incerta. Although a rare complication, hypothalamic dysfunction may occur as a stimulation-related side effect of Vim-DBS.
Deep brain stimulation of the anterior nuclei of the thalamus in focal epilepsy. [2023]To review the therapeutic effects of deep brain stimulation of the anterior nuclei of the thalamus (ANT-DBS) and the predictors of its effectiveness, safety, and adverse effects.
Multiple target deep brain stimulation for multiple sclerosis related and poststroke Holmes' tremor. [2022]The results from thalamic deep brain stimulation (DBS) for atypical tremor syndromes including tremor from multiple sclerosis (MS) and stroke are often disappointing. Three recent case reports have suggested that simultaneous stimulation of multiple thalamic targets can result in sustained improvement in such cases.
Long-term results of thalamic deep brain stimulation for essential tremor. [2022]Deep brain stimulation (DBS) of the ventral intermediate nucleus of the thalamus (VIM) has proven to be efficacious in the treatment of essential tremor (ET). The authors report on long-term follow-up of a series of patients treated at 1 institution by 1 neurosurgeon.
[Surgical Technique of Ventral Intermediate Thalamic Deep Brain Stimulation]. [2021]Deep brain stimulation(DBS)of ventral intermediate(Vim)thalamic nucleus is an established procedure for tremor disorders, however, there are technical variations among specialists. The most common indications of Vim DBS are essential tremor(ET)and tremor dominant Parkinson's disease(PD), and less commonly other tremor disorders including Holmes tremor are treated with the same procedure. The variations of the surgical technique exist in the preoperative imagings and planning of the DBS electrode trajectory. In this review, we explain about the basic concept of Vim DBS and our surgical method.
Patient selection and outcome of deep brain stimulation for multiple sclerosis-associated tremor. [2023]Tremor is a disabling symptom of multiple sclerosis (MS), with limited treatment modalities. Thalamic ventral-intermediate-nucleus (VIM) deep brain stimulation (DBS) is a method of neuromodulation. We describe the long-term outcomes of our carefully selected patients who underwent VIM DBS for their MS-associated tremor.