Tokyo, Aug. 31 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000058937) titled 'Long-term Randomized Crossover Trial for Adaptive versus Conventional Deep Brain Stimulation in Parkinson's Disease' on Aug. 30.
Study Type:
Interventional
Study Design:
Basic Design - Cross-over
Randomization - Randomized
Blinding - Double blind -all involved are blinded
Control - Active
Primary Sponsor:
Institute - Aizawa Hospital
Condition:
Condition - Parkinson's Disease
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - The objective of this study is to evaluate the long-term effects of adaptive deep brain stimulation (aDBS) compared with conventional DBS (cDBS) on daily functioning and motor symptoms in patients with Parkinson's disease, and to explore whether baseline clinical characteristics can predict differential treatment responses.
Basic objectives2 - Others
Intervention:
Interventions/Control_1 - adaptive deep brain stimulation (aDBS)
Interventions/Control_2 - conventional deep brain stimulation (cDBS)
Eligibility:
Age-lower limit - Not applicable
Age-upper limit - 75
years-old
>
Gender - Male and Female
Key inclusion criteria - - Patients with a clinical diagnosis of Parkinson's disease presenting with motor complications (dyskinesia or motor fluctuations)
Key exclusion criteria - - Patients with cognitive impairment defined as Mini-Mental State Examination (MMSE) score < 24
- Patients with significant psychiatric disorders requiring treatment changes
Target Size - 10
Recruitment Status:
Recruitment status - No longer recruiting
Date of protocol fixation - 2022 Year 01 Month 21 Day
Date of IRB - 2022 Year 01 Month 21 Day
Anticipated trial start date - 2022 Year 01 Month 21 Day
Last follow-up date - 2025 Year 03 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067403
Disclaimer: Curated by HT Syndication.
