Motor thalamus deep brain stimulation to improve movement and speech
Chronic Stimulation of the Motor Ventral Thalamus (VOP/VIM) for Motor Control in Humans
This trial will test turning deep brain stimulation on and off in adults who already have DBS implants for movement disorders to see if stimulation improves arm and hand movement, facial movement, speech, and swallowing.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | University of Pittsburgh Academic / other |
| Locations | 1 site (Pittsburgh, Pennsylvania) |
| Trial ID | NCT07056348 on ClinicalTrials.gov |
What this trial studies
Adults with implanted deep brain stimulators for movement disorders will undergo multiple in-person sessions in which DBS settings are adjusted and motor tasks are performed with stimulation ON and OFF. Tasks will measure contralateral upper-extremity movement speed, grip strength and modulation, facial movement, swallowing, and speech. Researchers will quantify immediate assistive effects when stimulation is ON and look for preliminary longer-lasting changes when stimulation is turned OFF. The protocol includes careful stimulation parameter adjustments and clinical measures to evaluate whether motor thalamus stimulation recruits relevant muscles and affects central motor control.
Who should consider this trial
Good fit: Adults aged 18–79 who already have DBS implanted for treatment of motor symptoms, can give informed consent, and can participate in repeated in-person testing are ideal candidates.
Not a fit: People with a history of seizures, severe cognitive or behavioral problems, other serious medical conditions that limit participation, or who are pregnant or breastfeeding are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, this approach could improve limb movement, facial control, speech, and swallowing for some patients and help optimize DBS settings for these functions.
How similar studies have performed: Related DBS work has shown benefits for tremor and some motor symptoms, but using motor thalamus stimulation specifically to recruit facial and swallowing muscles and to show lasting therapeutic effects is less well established.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Pittsburgh, Pennsylvania
- University of Pittsburgh — Pittsburgh, Pennsylvania, United States (Recruiting)
Study contacts
- Principal investigator: Jorge Gonzalez-Martinez, MD, PhD — University of Pittsburgh
- Study coordinator: Cierra Clark, MS
- Email: cic27@pitt.edu
- Phone: 240-441-4216
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.