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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorJorge Gonzalez-Martinez

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Deep Brain Stimulation of the Motor ThalamusExperimental treatment 1 intervention
Group B: Healthy Control ParticipantsNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Upper Limb Motor Function - Hand Dexterity

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.

Time frame
2 years
2

Upper Limb Motor Function - Grip Strength

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.

Time frame
2 years
3

Upper Limb Motor Function - Velocity

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.

Time frame
2 years
4

Upper Limb Motor Function - Strength Modulation

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.

Time frame
2 years

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Jorge Gonzalez-Martinez

Lead sponsor

University of Pittsburgh

Sponsor institution