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Procedure
Deep Brain Stimulation for Stroke
N/A
Recruiting
Led By Jorge Gonzalez-Martinez, MD/PhD
Research Sponsored by Jorge Gonzalez-Martinez
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 2 weeks, 4 weeks, 6 months.
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to investigate if deep brain stimulation can help improve hand/arm movement and speech for stroke survivors. Participants will have electrodes implanted in their brains, connected to external stimulators. The study will assess
Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Potential side effects may include discomfort or complications from surgical implantation of electrodes, changes in sensation or unwanted movements due to stimulation, headache, infection risk at the surgical site, and possible short-term changes in mood or cognition.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 2 weeks, 4 weeks, 6 months.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 2 weeks, 4 weeks, 6 months.
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Adverse Events
Discomfort and Pain
Secondary study objectives
Dexterity of Articulation AMRs
Dexterity of Articulation SMRs
Dysphagia
+5 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
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.
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Who is running the clinical trial?
Jorge Gonzalez-MartinezLead Sponsor
Jorge Gonzalez-Martinez, MD/PhDPrincipal InvestigatorUniversity of Pittsburgh
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