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NCT Number: NCT07056348

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

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.

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Key information

Conditions

Traumatic Brain Injury Brain Disease Brain Diseases Brain Injuries Brain Injuries, Traumatic Cardiovascular Diseases Central Nervous System Disease Central Nervous System Diseases Cerebrovascular Disorders Craniocerebral Trauma Essential Tremor Essential Tremor of Voice Essential Tremor, Movement Disorders Movement Disorders Movement Disorders (Incl Parkinsonism) Nervous System Diseases Stroke Trauma, Nervous System Vascular Diseases Wounds and Injuries

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Upper Limb Motor Function - Hand Dexterity

    Time frame: 2 years

    The investigators will use the Box and Blocks Test (unit counts) and Brinkmann Test (unit counts) to measure hand dexterity. Based on the preliminary data, the investigators will consider the number of participants with an 18% change in hand dexterity as minimally acceptable for improvement. Based on the preliminary data, the investigators will consider the number of participants with an improvement of 10% in the rate to be minimally acceptable.

  2. Upper Limb Motor Function - Grip Strength

    Time frame: 2 years

    The investigators will use the Box and Blocks Test, Brinkmann Test, and force dynamometer tests to measure grip strength (Newton). These tests will combine weight and height into a single BMI measurement in kg/m^2. Based on the preliminary data, the investigators will consider the number of participants with an 18% change in grip strength as minimally acceptable for improvement. Based on the preliminary data, the investigators will consider the number of participants with an improvement of 10% in the rate to be minimally acceptable.

  3. Upper Limb Motor Function - Velocity

    Time frame: 2 years

    The investigators will use the Box and Blocks Test, Brinkmann Test, and force dynamometer tests to measure velocity (Newton per millisecond). These tests will combine weight and height into a single BMI measurement in kg/m^2. Based on the preliminary data, the investigators will consider the number of participants with an 18% change in velocity as minimally acceptable for improvement. Based on the preliminary data, the investigators will consider the number of participants with an improvement of 10% in the rate to be minimally acceptable.

  4. Upper Limb Motor Function - Strength Modulation

    Time frame: 2 years

    The investigators will use the Box and Blocks Test, Brinkmann Test, and force dynamometer tests to measure strength modulation (Newton). These tests will combine weight and height into a single BMI measurement in kg/m^2. Based on the preliminary data, the investigators will consider the number of participants with an 18% change in modulation as minimally acceptable for improvement. Based on the preliminary data, the investigators will consider the number of participants with an improvement of 10% in the rate to be minimally acceptable.

  5. Facial Muscle Motor Function

    Time frame: 2 years

    The investigators will use electromyography (EMG) testing to measure muscle strength and range of motion produced by the subject during isometric facial movements (e.g. smile, tongue out, puckered lips, and open-close mouth), measured in by calculation of Area-Under-the-Curve with units of uV^2/ms. These tests will combine weight and height into a single BMI measurement in kg/m^2. Based on the preliminary data, the investigators will consider the number of participants with an increase of 50% in ROM as a minimally acceptable improvement in muscle strength.

  6. Swallowing Function

    Time frame: 2 years

    The investigators will use the modified barium swallow study (MBSS) to assess oropharyngeal swallow functions. This is a performance evaluation scale, that consist of 17 items with varying scales. The total score ranges from 0 to 55, where a higher score means a better outcome. Based on the preliminary data, the investigators will consider the number of participants with an increase of 1 point in at least 50% of the items of the Modified Barium Swallow Impairment Profile as a minimally acceptable improvement in swallow functions.

  7. Speech Intelligibility

    Time frame: 2 years

    The investigators will use the Assessment of Intelligibility of Dysarthric Speech (AIDS) to assess the quality of communication and intelligibility of speech at both word- and sentence-level. Intelligibility is calculated as the percentage of words correctly identified in the single-word task, and as the percentage of correctly transcribed words and speech rate (in words per minute) in the sentence task. Based on the preliminary data, the investigators will consider the number of participants with an improvement of 5% correctly transcribed to be minimally acceptable.

  8. Dexterity of Articulation AMRs

    Time frame: 2 years

    The investigators will measure dexterity of articulation by alternating motion rates (AMRs) of the repetitive plosive sound (pah, tah, and kah). Based on the preliminary data, the investigators will consider the number of participants with an improvement of 10% in the rate to be minimally acceptable.

  9. Dexterity of Articulation SMRs

    Time frame: 2 years

    The investigators will measure dexterity of articulation by sequential motion rates (SMRs) of the repetitive plosive sound (pah, tah, and kah). Based on the preliminary data, the investigators will consider the number of participants with an improvement of 10% in the rate to be minimally acceptable.

  10. Oral Motor Functions

    Time frame: 2 years

    The investigators will use the 2nd Edition Frenchay Dysarthria Assessment (FDA-2) to measure patterns of oral motor functions, with a particular focus on the following subsections: Respiration, Lips, Palate, Laryngeal, and Tongue. Each subsection is rated on a scale from "a" to "e", where "a" means normal for age, and "e" means unable to undertake task/movement/sound. So a score closer to "a" means a better outcome. Based on the preliminary data, the investigators will consider the number of participants with an improvement in severity level (e.g., from considerable to moderate severity, or a score of D to C) to be minimally acceptable.

  11. Respiration Capacity - Total Exhaled Volume

    Time frame: 2 years

    The investigators will measure pulmonary function and respiratory capacity by performing a spirometry test with focus on the forced vital capacity (FVC). The FVC is the total volume of air that can be forcefully exhaled after a maximal inhalation and this will be measured in liters (L). Based on the preliminary data, the investigators will consider the number of participants with an improvement of 12% in the rate to be minimally acceptable.

  12. Respiration Capacity - Volume Exhaled

    Time frame: 2 years

    The investigators will measure pulmonary function and respiratory capacity by performing a spirometry test with focus on the volume exhaled in the first second (FEV1). The FEV1 is the volume of air exhaled in the first second of a forced exhalation and this will be measured in liters (L). Based on the preliminary data, the investigators will consider the number of participants with an improvement of 12% in the rate to be minimally acceptable.

  13. Respiration Capacity - FEV1/FVC Ratio

    Time frame: 2 years

    The investigators will measure pulmonary function and respiratory capacity by performing a spirometry test with focus on ratio of the forced expiratory volume in one second (FEV1) to the forced vital capacity (FVC). The ratio is expressed as a unitless percentage. Based on the preliminary data, the investigators will consider the number of participants with an improvement of 12% in the rate to be minimally acceptable.

  14. Oral Motor Strength

    Time frame: 2 years

    The investigators will use the Iowa Performance Instrument (IOPI) to measure motor strength of tongue and lip using maximum force and endurance. IOPI instrument measures force applied from oral cavity by kPa. Based on the preliminary data, the investigators will consider the number of participants with an improvement of 10% in the rate to be minimally acceptable.

Study contacts

Contact information is provided by the study sponsor or research team.

Cierra Clark, MS

CONTACT

[email protected]

240-441-4216

Elvira Pirondini, PhD

CONTACT

[email protected]

412-636-0595

Sponsors and collaborators

Lead sponsor

Jorge Gonzalez-Martinez

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2030
Study completion
2030
First posted
Jul 9, 2025
Registry last updated
Dec 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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