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NCT07056348NARecruitingAccepts Healthy Volunteers

Long-term Brain Stimulation of the Motor Ventral Thalamus (VOP/VIM) to Improve Motor Function

Jorge Gonzalez-Martinez

Start Date

5/10/2022

Completion Date

12/31/2030

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.

Detailed Description

The study is designed to assess the assistive effects of DBS (i.e., immediate effects when the stimulation is turned ON) and obtain preliminary evidence for therapeutic effects (i.e., long-lasting effects with stimulation OFF). Researchers will 1) quantify the ability to recruit facial and oropharyngeal muscles with electrical stimulation of the motor thalamus in patients with DBS for movement disorders, 2) quantify the ability to recruit arm and hand muscles with electrical stimulation of the motor thalamus in patients with DBS, and 3) verify if the delivery of DBS has effects on the central nervous system with clinical measures.

Eligibility Criteria

Age Range: 18 years to 80 years

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.

Interventions

DEVICE

Deep Brain Stimulation (DBS) of the Motor Thalamus

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Conditions

Traumatic Brain InjuryStrokeBrain DiseaseMovement Disorders (Incl Parkinsonism)Central Nervous System DiseaseEssential Tremor, Movement DisordersEssential Tremor of Voice

Locations

University of Pittsburgh

Pittsburgh, Pennsylvania 15213

United States