Improving dyskinesia in Parkinson's disease with interleaving stimulation
Interleaving Stimulation Improves Dyskinesia in Parkinson's Disease: Randomized, Double-blind, Controlled Trial
This study is testing if a new type of brain stimulation can help reduce movement problems in people with Parkinson's disease better than the usual method.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 30 Years to 65 Years |
| Sex | All |
| Sponsor | Huashan Hospital Academic / other |
| Locations | 1 site (Shanghai, Shanghai) |
| Trial ID | NCT06239454 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of interleaving stimulation compared to empirical stimulation in managing dyskinesia in patients with Parkinson's disease. It is a prospective, randomized, double-blind, controlled trial involving 50 participants who will be assigned to either the interleaving stimulation modes group or the empirical stimulation modes group. The study will measure changes in dyskinesia scores, quality of life, and other relevant assessments over a 12-month period. Statistical analysis will be conducted to determine the differences in outcomes between the two groups.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 30-65 with a diagnosis of Parkinson's disease who have had the condition for at least 5 years and are not adequately controlled by medication.
Not a fit: Patients with major comorbidities, untreated significant depression, or those who have undergone previous neurosurgical procedures may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved management of dyskinesia symptoms in Parkinson's disease patients.
How similar studies have performed: While there have been studies on stimulation techniques in Parkinson's disease, the specific approach of interleaving stimulation is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 1. Patients at the age of 30-65 years old. 2. Patients diagnosed as Parkinson's disease according to the UK Parkinson's Disease Society Brain Bank criteria. 3. Patients at Hoehn and Yahr stage 3 or lower in the on-state and stage 2 - 4 in the off-state. 4. The disease duration of 5 years or more. 5. Patients with deep levodopa-responsive Parkinson's disease, and are not adequately controlled by drug therapy. Exclusion Criteria: * major illness or medical comorbidities, depression that is untreated but judged to be clinically significant by an investigator, cochlear implants, cardiac pacemakers, needs for diathermy, anticoagulant therapy, previous neuro-surgical procedure or ablative therapy, frank dementia according to cognitive screening, drug or alcohol abuse, being a woman of child-bearing potential, having a positive pregnancy test, or presence of a terminal illness.
Where this trial is running
Shanghai, Shanghai
- Huashan Hospital — Shanghai, Shanghai, China (Recruiting)
Study contacts
- Study coordinator: Jian-Jun Wu, MD
- Email: jungliw@gmail.com
- Phone: 86-21-52888163
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.