RECRUITING

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

Conditions

Traumatic Brain Injury Stroke Brain Disease Movement Disorders (Incl Parkinsonism)Central Nervous System Disease Essential Tremor, Movement Disorders Essential Tremor of Voice

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Chronic Stimulation of the Motor Ventral Thalamus (VOP/VIM) for Motor Control in Humans

Quick Facts

Study Start:2022-05-10

Study Completion:2030-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT07056348

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 80 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Age lower than 80 to better tolerate intraoperative testing. * All Movement disorder patients, older than 18 and younger than 80, 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. * Subject is ≥18 years of age and \< 80 years of age. * Subject is willing and able to comply with scheduled visits and study procedures.	* Patients will be excluded from the study if there is any seizure history, to avoid the increased epileptogenic risk during stimulation testing. * Patients with bilateral tremors will be excluded. * Patients with vasovagal response history and loss of consciousness history will be excluded. * Subject has severe behavioral or cognitive problems that preclude participation in the study, in the opinion of the investigator would impact participation in the study. * Participants who have any serious disease or disorder (e.g. cancer, severe cardiac or respiratory disease, neurological conditions other than stroke, etc.) or cognitive impairments that could affect their ability to participate in this study. * Female subjects are pregnant or breastfeeding.

Inclusion Criteria

Exclusion Criteria

* Age lower than 80 to better tolerate intraoperative testing.
* All Movement disorder patients, older than 18 and younger than 80, 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.
* Subject is ≥18 years of age and \< 80 years of age.
* Subject is willing and able to comply with scheduled visits and study procedures.

* Patients will be excluded from the study if there is any seizure history, to avoid the increased epileptogenic risk during stimulation testing.
* Patients with bilateral tremors will be excluded.
* Patients with vasovagal response history and loss of consciousness history will be excluded.
* Subject has severe behavioral or cognitive problems that preclude participation in the study, in the opinion of the investigator would impact participation in the study.
* Participants who have any serious disease or disorder (e.g. cancer, severe cardiac or respiratory disease, neurological conditions other than stroke, etc.) or cognitive impairments that could affect their ability to participate in this study.
* Female subjects are pregnant or breastfeeding.

Contacts and Locations

Study Contact

Cierra Clark, MS

CONTACT

240-441-4216

cic27@pitt.edu

Elvira Pirondini, PhD

CONTACT

412-636-0595

elvirap@pitt.edu

Principal Investigator

Jorge Gonzalez-Martinez, MD, PhD

PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Study Locations (Sites)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213

United States

Collaborators and Investigators

Sponsor: University of Pittsburgh

Jorge Gonzalez-Martinez, MD, PhD, PRINCIPAL_INVESTIGATOR, University of Pittsburgh

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-05-10

Study Completion Date2030-12-31

Study Record Updates

Study Start Date2022-05-10

Study Completion Date2030-12-31

Terms related to this study

Additional Relevant MeSH Terms

Traumatic Brain Injury
Stroke
Brain Disease
Movement Disorders (Incl Parkinsonism)
Central Nervous System Disease
Essential Tremor, Movement Disorders
Essential Tremor of Voice