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

Jorge Gonzalez-Martinez

Status: Enrolling

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

Treatments: Device: Deep Brain Stimulation (DBS) of the Motor Thalamus

Study type: Interventional

Funder types: Other

Identifiers

NCT07056348

STUDY21100020

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Deep Brain Stimulation of the Motor Thalamus

Experimental group

Description:

Individuals with deep brain stimulation device implanted in the motor thalamus for movement disorders treatment who also sustain speech, swallowing, and motor deficits.

Treatment:

Device: Deep Brain Stimulation (DBS) of the Motor Thalamus

Healthy Control Participants

No Intervention group

Description:

The investigators aim to include healthy control subjects who will complete the language and upper-limb tasks. The healthy subjects will not undergo any surgical procedures.