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

Part of paid clinical trials in Pittsburgh, Pennsylvania.

Sponsor
Jorge Gonzalez-Martinez
Study ID
NCT07056348
Status
Recruiting

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Accepted

Interventions

  • Deep Brain Stimulation (DBS) of the Motor Thalamus — DEVICE
    All participants enrolled will undergo stimulation parameters tuning of deep brain stimulation electrode leads. All subjects will participate in a series of experiments to evaluate the stimulation effects on movement of face and upper extremities, swallowing, and speech abilities.

Study Details

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.

Key Dates

Start date
May 10, 2022
Status verified
Oct 2025
Primary completion
Dec 31, 2030
Completion
Dec 31, 2030

Study Design

Enrollment
60 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Deep Brain Stimulation of the Motor Thalamus
    Individuals with deep brain stimulation device implanted in the motor thalamus for movement disorders treatment who also sustain speech, swallowing, and motor deficits.
  • No Intervention: Healthy Control Participants
    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.

Primary Outcome Measure

Upper Limb Motor Function - Hand Dexterity [ Time Frame: 2 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of PittsburghPittsburghPennsylvania15213
Cierra Clark, MS
240-441-4216
Elvira Pirondini, PhD
412-636-0595
Jorge Gonzalez-Martinez, MD, PhD (PRINCIPAL_INVESTIGATOR)

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