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Procedure

Deep Brain Stimulation of the Motor Thalamus for Central Nervous System Disorders

N/A
Waitlist Available
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

Study 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.Check my eligibility
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.See study design
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 weeks
Treatment ~ Varies
Follow Up ~baseline, 2 weeks, 4 weeks, 6 months.
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 2 weeks, 4 weeks, 6 months. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Adverse Events
Discomfort and Pain
Secondary outcome measures
Dexterity of Articulation AMRs
Dexterity of Articulation SMRs
Dysphagia
+5 more

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.

Find a Location

Who is running the clinical trial?

Jorge Gonzalez-MartinezLead Sponsor
Jorge Gonzalez-Martinez, MD/PhDPrincipal InvestigatorUniversity of Pittsburgh

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the age criterion for participation in this study limited to individuals below 55 years of age?

"Individuals aged 18 to 70 years old are eligible for enrollment based on the study's inclusion criteria."

Answered by AI

Can individuals such as myself participate in this clinical study?

"To participate in this research study, individuals must have neurological disorders and fall within the age range of 18 to 70 years. The trial aims to enroll a total of 10 subjects."

Answered by AI

Are there ongoing efforts to actively enroll participants in this trial?

"As per clinicaltrials.gov, this particular investigation is not in the active recruitment phase. The trial's initial posting date was March 1st, 2024, and it was last revised on March 4th, 2024. However, despite its current inactive status for patient enrollment, there are currently a total of 1775 other trials seeking participants."

Answered by AI

What is the primary objective of conducting this clinical trial?

"The objective of this examination, which will be observed throughout the Baseline period and at 2 weeks, 4 weeks, and finally after a span of 6 months, is to evaluate Adverse Events. Supplementary endpoints involve Muscle weakness characterized by assessing muscle strength and range of motion exhibited during various facial movements such as smiling, sticking out the tongue, puckering lips, and opening-closing mouth. An enhancement in muscle strength corresponding to a minimum increase of 50% in range of motion (ROM) is deemed acceptable based on initial findings."

Answered by AI
~7 spots leftby May 2029