DBS and SCS Therapy Improve Motor Function in Multiple System Atrophy With Predominant Parkinsonism

NCT04617873 | Unknown

• 1 other identifier: 2020005
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Multiple system atrophy (MSA) is a debilitating and fatal neurodegenerative disorder and symptomatic therapeutic strategies are still limited.The parkinsonian type of MSA (MSA-P) has parkinsonian symptoms as its prominent manifestation, although Deep brain stimulation (DBS) at the subthalamic nucleus or globus pallidus interna has been an established treatment for Parkinson's disease patients, it is mostly ineffective in MSA-P patients, the improvement in motor function as short-lasting and rapidly followed by the early appearance of freezing of gait (FOG) and postural instability that counteracted DBS benefits and often leads to significant disability and loss of quality of life. Recently, some pilot studies demonstrated the safety and significant therapeutic outcome of SCS for FOG.The purpose of this clinical study is to understand the effectiveness of DBS combined with SCS for symptomatic treatment of MSA-P.

Conditions

Multiple System Atrophy, Parkinson Variant (Disorder)

Keywords

Deep Brain Stimulation; Spine Cord Stimulation; Multiple System Atrophy

Outcome Measures

Primary Outcomes (3)

• change in motor examination( Movement Disorders Society's revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) III) at 3 months postoperatively

  demonstrate the statistically significant difference in change of motor score (MDS-UPDRS III) from baseline( Off medication) to 3months(On stimulation/Off medication); MDS-UPDRS III ranges from 0 to 132, higher scores mean a worse outcome .

  3 months after surgery

• change in motor examination( Movement Disorders Society's revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) III) at 12 months postoperatively

  demonstrate statistically significant improvement in score of MDS-UPDRS III from Off stimulation/Off medication state to On stimulation/Off medication state at 12 months; MDS-UPDRS III ranges from 0 to 132, higher scores mean a worse outcome

  12 months after surgery

• change in PD-related quality of life(PDQ-39)

  demonstrate statistically significant improvement in score of PDQ-39 from baseline to 12 months;PDQ-39 was used to evaluate the improvement in quality of life, ranged from 0 to 156, higher scores mean a worse outcome.

  12 months after surgery

Secondary Outcomes (8)

• change in the score of Gait and Fall Questionnaire (GFQ) at 3 months postoperatively

  3 months after surgery

• change in the score of Gait and Fall Questionnaire (GFQ) at 12 months postoperatively

  12 months after surgery

• change in severity of freezing of gait (New Freezing of Gait Questionnaire,NFOGQ) at 3 months postoperatively

  3 months after surgery

• change in severity of freezing of gait (New Freezing of Gait Questionnaire,NFOGQ) at 12 months postoperatively

  12 months after surgery

• Clinical Global Impression-Global Improvement (CGI-GI) at 3 months postoperatively

  3 months after surgery

Study Arms (1)

Deep bain stimulation and Spinal cord stimulation therapy

EXPERIMENTAL

The patients in this group will receive bilateral STN-DBS and SCS stimulation

Procedure: Bilateral STN-DBS and T10-T12 SCS

Interventions

Bilateral STN-DBS and T10-T12 SCS PROCEDURE

simultaneous stimulation of bilaterally-STN-DBS combined with spinal cord stimulation

Deep bain stimulation and Spinal cord stimulation therapy

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• meet the clinical diagnostic criteria of possible MSA-P;
• with moderate to severe parkinsonism motor symptoms;
• accept levodopa treatment for at least 6 months, and stable medication dose for at least 4 weeks;

You may not qualify if:

• severe orthostatic hypotension;
• score of Hamilton Depression Scale is more than 24.
• score of Mini-mental State Examination is less than 24;
• elevated risks for bleeding
• with evident lesions on MRI structural images at T8-12 spinal cord segment

Sponsors & Collaborators

• zhangyuqing: lead

Study Sites (1)

Capital Medical University of Xuanwu Hospital

Beijing, China

RECRUITING

MeSH Terms

Conditions

Multiple System Atrophy

Condition Hierarchy (Ancestors)

Primary Dysautonomias; Autonomic Nervous System Diseases; Nervous System Diseases; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Yuqing Zhang, MD

  Capital Medical University- Xuanwu Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jiping Li, MD

CONTACT

8610-83198899-8630; yhljp89@163.com

Shanshan Mei, MD

CONTACT

8610-83198899-2282; sophy33@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: October 30, 2020
• First Posted: November 5, 2020
• Study Start: January 5, 2021
• Primary Completion: January 1, 2023
• Study Completion: January 1, 2024
• Last Updated: January 14, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)