Deep Brain Stimulation for Movement Disorders
This study is for people aged 18 to 80 who already have Deep Brain Stimulation (DBS) devices implanted for movement disorders. Researchers want to understand how adjusting the DBS settings affects movement in your face, arms, and hands, as well as your swallowing and speech. You would participate in experiments where your DBS settings are adjusted, and then you would perform tasks to measure your movement speed, grip strength, and how well you can control your muscles. The study will look at how well DBS helps immediately and if it has longer-lasting effects. The main goals are to see how DBS affects hand dexterity, grip strength, and movement velocity over two years.
- Study design
- This is an interventional study with a planned enrollment of 60 participants. It is designed to assess the effects of Deep Brain Stimulation (DBS) on motor function.
- What's involved
- You would participate in multiple sessions involving adjustments to your DBS parameters and then perform tasks to evaluate your movement, swallowing, and speech abilities.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your upper limb motor function, including hand dexterity, grip strength, and velocity, will be measured at 2 years.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Long-term Brain Stimulation of the Motor Ventral Thalamus (VOP/VIM) to Improve Motor Function
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Jorge Gonzalez-Martinez, MD, PhD · PRINCIPAL_INVESTIGATOR · University of Pittsburgh
Who to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- Upper Limb Motor Function - Hand Dexterity2 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.
- Upper Limb Motor Function - Grip Strength2 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.
- Upper Limb Motor Function - Velocity2 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.
- Upper Limb Motor Function - Strength Modulation2 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.
- Facial Muscle Motor Function2 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.
- Swallowing Function2 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.
- Speech Intelligibility2 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.
- Dexterity of Articulation AMRs2 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.
- Dexterity of Articulation SMRs2 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.
- Oral Motor Functions2 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.
- Respiration Capacity - Total Exhaled Volume2 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.
- Respiration Capacity - Volume Exhaled2 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.
- Respiration Capacity - FEV1/FVC Ratio2 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.
- Oral Motor Strength2 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.