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Multimodal analysis study on intrathecal baclofen infusion therapy for hereditary spastic paraplegia

Multimodal analysis study on intrathecal baclofen infusion therapy for hereditary spastic paraplegia

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500114250
Enrollment
Unknown
Registered
2025-12-09
Start date
2025-12-30
Completion date
Unknown
Last updated
2025-12-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hereditary spastic paraplegia (HSP)

Interventions

Test group:Intrathecal baclofen infusion therapy

Sponsors

The University of Hongkong - Shenzhen Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Clinically diagnosed as HSP; 2. At least two lower limb muscle groups have a Modified Ashworth Scale (MAS) score of >= 3; 3. Spasticity and the pain it causes seriously affect daily life and increase the difficulty of rehabilitation and care; 4. The effect of oral baclofen and other antispastic drugs is unsatisfactory or the patient cannot tolerate the related side effects; 5. Baclofen intrathecal test is effective and the patient is willing to receive ITB treatment.

Exclusion criteria

Exclusion criteria: 1. There are severe cognitive and mental disorders, and the patient is unable to cooperate with the treatment. 2. There are serious diseases of important organs such as the heart and lungs, and the patient cannot tolerate the treatment. 3. There is uncontrolled epilepsy, and the patient cannot tolerate the treatment. 4. There is an infection at the site of baclofen pump implantation. 5. Botulinum toxin local injection treatment was received within 6 months.

Design outcomes

Primary

MeasureTime frame
Spasm severity;

Secondary

MeasureTime frame
Gait analysis;Sctivities of daily living;

Countries

China

Contacts

Public ContactYongjie Li

The University of Hongkong - Shenzhen Hospital

liyj5@hku-szh.org+86 755 8691 3333

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026