Spinal Cord Stimulation Therapy for Hereditary Spastic Paraplegias Patients

NCT05196178 | Unknown

• 1 other identifier: 20211116
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

It's a single-center, prospective, open label clinical study with a 12 months follow-up period, to investigate the therapeutic effect and safety of spinal cord stimulation (SCS) on motor function and gait in patients with pure Hereditary Spastic Paraplegias.

Conditions

Motor Function; Gait

Keywords

spinal cord stimulation; Hereditary Spastic Paraplegias; Spasticity; gait

Outcome Measures

Primary Outcomes (1)

• change in spastic paraplegia rating scale(SPRS)

  demonstrate the statistically significant improvement in score of spastic paraplegia rating scale(SPRS) from baseline( Off medication) to 12 months(On stimulation/Off medication); The score of SPRS ranges from 0 to 52, higher scores mean a worse outcome .

  twelve months after surgery

Secondary Outcomes (5)

• change in the score of Modified Ashworth Scale

  twelve months after surgery

• change in Activities of Daily Living Scale (ADL)

  twelve months after surgery

• change in Tinetti Balance and Gait Analysis

  twelve months after surgery

• change in Berg Balance Scale(BBS)

  twelve months after surgery

• Clinical Global Impression-Global Improvement

  twelve months after surgery

Study Arms (1)

Spinal cord stimulation therapy

EXPERIMENTAL

Spinal cord stimulation at the thoracic levels ranging from T10 to T12.

Procedure: Spinal cord stimulation

Interventions

Spinal cord stimulation PROCEDURE

Paddle-shaped Spinal cord stimulation electrode with 16 contacts (AdaptiveStim® 39, 565;Medtronic, USA) will be implanted into the epidural space at the thoracic levels ranging from T10 to T12.

Spinal cord stimulation therapy

Eligibility Criteria

• Age: 14 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• aged between 14 and 70 years
• patients with pure hereditary spastic paraplegias
• with progressive weakness and spasticity of the lower limbs, and the gait dysfunction treatable by medication but not adequately controlled with medications
• Understand potential risk/benefit, consent to the study, study procedures, and agree to complete the study follow-up visits and comply with the study protocol requirements.

You may not qualify if:

• cognitive impairment ( MMSE≤24), depression (HAMD\>24),acute psychosis, active alcohol or drug abuse, terminal illness, and any major medical or psychological histories, diagnoses, conditions, or comorbidities that would interfere with participation in the study per the investigatior's medical judgment
• surgical or medical contraindications to spinal cord stimulation surgery(e.g. uncontrolled hypertension, advanced coronary artery disease).

Sponsors & Collaborators

• Xuanwu Hospital, Beijing: lead

Study Sites (1)

Xuanwu Hospital,Capital Medical University

Beijing, Beijing Municipality, 100053, China

RECRUITING

MeSH Terms

Conditions

Spastic Paraplegia, Hereditary; Muscle Spasticity

Interventions

Spinal Cord Stimulation

Condition Hierarchy (Ancestors)

Hereditary Sensory and Motor Neuropathy; Nervous System Malformations; Nervous System Diseases; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Polyneuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Genetic Diseases, Inborn; Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Yuqing Zhang, MD

  Xuanwu Hospital, Beijing

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jiping Li, MD

CONTACT

8610-83198899-8630; yhljp89@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

Study Record Dates

• First Submitted: December 2, 2021
• First Posted: January 19, 2022
• Study Start: November 15, 2021
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: January 19, 2022

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)