Recruiting

Deep Brain Stimulation

Sponsor:

Jorge Gonzalez-Martinez

Code:

NCT07056348

Conditions

Traumatic Brain Injury

Stroke

Brain Disease

Movement Disorders (Incl Parkinsonism)

Central Nervous System Disease

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

Deep Brain Stimulation (DBS) of the Motor Thalamus

Study Details

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.

Conditions

Traumatic Brain Injury

Stroke

Brain Disease

Movement Disorders (Incl Parkinsonism)

Central Nervous System Disease

Study ID

NCT07056348

Start date

May 10, 2022

Status verified date

Oct, 2025

Completion date

Dec 31, 2030

Anticipated

Primary completion date

Dec 31, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

60 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

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.

Interventions

Deep Brain Stimulation (DBS) of the Motor Thalamus

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.

Primary outcome measure

  • Upper Limb Motor Function - Hand Dexterity [ Time Frame: 2 years ]
  • Upper Limb Motor Function - Grip Strength [ Time Frame: 2 years ]
  • Upper Limb Motor Function - Velocity [ Time Frame: 2 years ]
  • Upper Limb Motor Function - Strength Modulation [ Time Frame: 2 years ]
  • Facial Muscle Motor Function [ Time Frame: 2 years ]
  • Swallowing Function [ Time Frame: 2 years ]
  • Speech Intelligibility [ Time Frame: 2 years ]
  • Dexterity of Articulation AMRs [ Time Frame: 2 years ]
  • Dexterity of Articulation SMRs [ Time Frame: 2 years ]
  • Oral Motor Functions [ Time Frame: 2 years ]
  • Respiration Capacity - Total Exhaled Volume [ Time Frame: 2 years ]
  • Respiration Capacity - Volume Exhaled [ Time Frame: 2 years ]
  • Respiration Capacity - FEV1/FVC Ratio [ Time Frame: 2 years ]
  • Oral Motor Strength [ Time Frame: 2 years ]

Central Contacts and Locations

Central contacts

Cierra Clark, MS

240-441-4216cic27@pitt.edu

Elvira Pirondini, PhD

412-636-0595elvirap@pitt.edu

Locations

University of Pittsburgh

Recruiting

Pittsburgh, Pennsylvania, United States, 15213

Contacts

Cierra Clark, MS

240-441-4216cic27@pitt.edu

Elvira Pirondini, PhD

412-636-0595elvirap@pitt.edu

Principal Investigator:

Jorge Gonzalez-Martinez, MD, PhD

More Information

Sponsor

Jorge Gonzalez-Martinez

Last update posted

Dec 16, 2025

Last verified

Oct, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Jorge Gonzalez-Martinez on 2025-12-16.