Deep brain stimulation for movement disorders like Parkinson's disease
Deep Brain Stimulation Surgery for Movement Disorders
NA · National Institutes of Health Clinical Center (CC) · NCT01581580
This study tests whether deep brain stimulation surgery can help people with movement disorders like Parkinson's disease feel better when other treatments haven't worked.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Sponsor | National Institutes of Health Clinical Center (CC) (nih) |
| Locations | 1 site (Bethesda, Maryland) |
| Trial ID | NCT01581580 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of deep brain stimulation (DBS) surgery on patients with movement disorders such as Parkinson's disease, essential tremor, and dystonia. It aims to collect data on brain and nerve cell function during the surgery while providing standard care treatment. Patients aged 18 and older who have not responded well to other treatments will be screened for eligibility and may undergo DBS to alleviate their symptoms. The study will utilize pre- and post-operative imaging and intra-operative recordings to assess the effectiveness of the procedure.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with medically refractory Parkinson's disease, dystonia, or essential tremor.
Not a fit: Patients who are unable or unwilling to provide informed consent or do not have medically refractory conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this could significantly improve the quality of life for patients suffering from movement disorders.
How similar studies have performed: Other studies have shown success with deep brain stimulation for similar conditions, indicating a promising approach.
Eligibility criteria
Show full inclusion / exclusion criteria
* INCLUSION CRITERIA: To be eligible for entry into the study, candidates must meet all the following criteria: Be 18 years of age or older. Able to provide informed consent. Have a clinical diagnosis of one of the following as confirmed by the NIH movement disorders clinic team and the multi-disciplinary DBS surgical conference, and deemed as appropriate for the use of Deep Brain Stimulation therapy: * idiopathic PD not adequately controlled with medication or * primary dystonia that is medically refractory, or * ET that is not adequately controlled by medications or constitutes a significant functional disability. EXCLUSION CRITERIA: Candidates will be excluded if they: Are unable or unwilling to give informed consent to the research procedures.
Where this trial is running
Bethesda, Maryland
- National Institutes of Health Clinical Center — Bethesda, Maryland, United States (RECRUITING)
Study contacts
- Principal investigator: Kareem A Zaghloul, M.D. — National Institute of Neurological Disorders and Stroke (NINDS)
- Study coordinator: Sharon C Park
- Email: sharon.park@nih.gov
- Phone: (301) 496-2921
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.
Conditions: Parkinson's Disease, Essential Tremor, Dystonia, Deep Brain Stimulation, Neurophysiology, Movement Disorder, Parkinson Disease