NCT07056348 Long-term Brain Stimulation of the Motor Ventral Thalamus (VOP/VIM) to Improve Motor Function
| NCT ID | NCT07056348 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Jorge Gonzalez-Martinez |
| Condition | Traumatic Brain Injury |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2022-05-10 |
| Primary Completion | 2030-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2022-05-10 with a primary completion date of 2030-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study aims to recruit patients already implanted with Deep Brain Stimulation (DBS) for movement disorders to complete tasks assessing parameters of motor output, speech, and swallowing functions, both with and without stimulation. DBS parameters would be adjusted prior to motor testing. Patients would then participate in multiple sessions performing contralateral upper extremity movement tasks measuring movement speed, grip strength, and strength modulation, facial movement, swallowing, and speech tasks.
Eligibility Criteria
Inclusion Criteria: * Movement disorder patients ≥18 years of age and \< 80 years of age, who will be implanted with DBS for treatment of motor symptoms. * Subject has provided written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization, where applicable, prior to any study-related procedures. Exclusion Criteria: * History of seizure disorders * Vasovagal response history and loss of consciousness history * Severe behavioral or cognitive problems that preclude participation in the study, in the opinion of the investigator would impact participation in the study. * Any serious disease or disorder (e.g. cancer, severe cardiac or respiratory disease, neurological conditions other than current movement disorder) or cognitive impairments that could impair ability to participate in this study. * Females who are pregnant or breastfeeding.
Contact & Investigator
Jorge Gonzalez-Martinez, MD, PhD
PRINCIPAL INVESTIGATOR
University of Pittsburgh
Frequently Asked Questions
Who can join the NCT07056348 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Traumatic Brain Injury. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07056348 currently recruiting?
Yes, NCT07056348 is actively recruiting participants. Contact the research team at cic27@pitt.edu for enrollment information.
Where is the NCT07056348 trial being conducted?
This trial is being conducted at Pittsburgh, United States.
Who is sponsoring the NCT07056348 clinical trial?
NCT07056348 is sponsored by Jorge Gonzalez-Martinez. The principal investigator is Jorge Gonzalez-Martinez, MD, PhD at University of Pittsburgh. The trial plans to enroll 60 participants.