PSA-STN: PSA Versus STN DBS for Dopamine-resistant TD-PD
Study Details
Study Description
Brief Summary
The aim of this study is to compare the effectiveness of the deep brain stimulation in the posterior subthalamic area (PSA) versus the subthalamic nucleus (STN) for the treatment of dopamine-resistant tremor-dominant Parkinson's disease (PD) in a randomized, double-blinded, cross-over manner.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
This is a randomized, double-blinded, crossover trial aiming at comparing the efficacy of PSA and STN DBS in treating dopamine-resistant tremor-dominant PD. Enrolled patients will undergo bilateral DBS surgery, targeting both PSA and STN with single trajectory. Three months post-implantation, patients enter a 4-month double-blinded crossover phase with PSA and STN DBS in randomized order. After 7 months post-implantation (at the end of the crossover phase), patients enter an open-label phase during which programming parameters are not restricted until the termination of the study at 12-month follow-up.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: PSA-STN Participants randomized in this arm will receive bilateral PSA stimulation in the first two months in the randomized phase and then will be crossovered to the bilateral STN stimulation for another two months. |
Device: Deep brain stimulation
active DBS with optimal stimulating parameters
|
| Experimental: STN-PSA Participants randomized in this arm will receive bilateral STN stimulation in the first two months in the randomized phase and then will be crossovered to the bilateral PSA stimulation for another two months. |
Device: Deep brain stimulation
active DBS with optimal stimulating parameters
|
Outcome Measures
Primary Outcome Measures
- Change from baseline Movement Disorder Society-sponsord Unified Parkinson's Disease Rating Scale Part III at 5 months [5 months]
in the off-medication condition
- Change from baseline Movement Disorder Society-sponsord Unified Parkinson's Disease Rating Scale Part III at 7 months [7 months]
in the off-medication condition
Secondary Outcome Measures
- Change from baseline Fahn-Tolosa-Marin Clinical Rating Scale for Tremor to 5 months [5 months]
- Change from baseline Fahn-Tolosa-Marin Clinical Rating Scale for Tremor to 7 months [7 months]
- Change from baseline Timed up and go test to 5 months [5 months]
in the off-medication condition
- Change from baseline Timed up and go test to 7 months [7 months]
in the off-medication condition
- Change from baseline Berg balance scale to 5 months [5 months]
in the off-medication condition
- Change from baseline Berg balance scale to 7 months [7 months]
in the off-medication condition
- Change from baseline 39-item Parkinsons disease questionnaire to 5 months [5 months]
- Change from baseline 39-item Parkinsons disease questionnaire to 7 months [7 months]
- Change from baseline Levodopa equivalent daily dose to 5 months [5 months]
- Change from baseline Levodopa equivalent daily dose to 7 months [7 months]
- Change from baseline maximal phonatory time to 5 months [5 months]
- Change from baseline maximal phonatory time to 7 months [7 months]
- Change from baseline dysphonia severity index to 5 months [5 months]
- Change from baseline dysphonia severity index to 7 months [7 months]
- Change from baseline Montreal Cognitive Assessment to 5 months [5 months]
- Change from baseline Montreal Cognitive Assessment to 7 months [7 months]
- Change from baseline Beck depression inventory to 5 months [5 months]
- Change from baseline Beck depression inventory to 7 months [7 months]
- Adverse events [up to 12 months after surgery]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
diagnosis of idiopathic Parkinson's disease
-
tremor-dominant subtype in the on-medication condition
-
dopamine-resistant tremor (i.e., preoperative levodopa responsiveness < 24% regarding the tremor subscore of the MDS UPDRS-III or uncontrolled tremor regardless of LEDD over 900 mg or maximal tolerated dose)
Exclusion Criteria:
-
Atypical parkinsonism
-
History of stroke, encephalitis, neuroleptic uses, MRI scan with evidence of significant brain atrophy, lacunar infracts, or other conditions that might interfere with the intracranial surgery
-
Presence of cognitive, or psychiatric or other co-morbidities (e.g., dementia, epilepsy, cranial traumatism, brain tumor, schizophrenia, severe depression or bipolar disorder, personality disorder, etc.) that might interfere with the patient's ability to complete the evaluations or to provide informed consent
-
Presence of anatomical abnormalities in the target region
-
Clinically significant medical history that would increase pre-/post-operative complications
-
Other conditions considered by the investigators that might interfere with the surgery procedure, the follow-ups, and the interpretation of the data
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine | Shanghai | Shanghai | China | 200025 |
Sponsors and Collaborators
- Ruijin Hospital
- Suzhou Sceneray Medical Co. , Ltd
Investigators
- Principal Investigator: Dianyou Li, MD, PhD, Ruijin Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- TDPSA