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Epidural Spinal Cord Stimulation for Lower-Limb Impairment in Adrenomyeloneuropathy (AMN): A Prospective, Multicenter, Single-Arm Clinical Trial.

Epidural Spinal Cord Stimulation for Lower-Limb Impairment in Adrenomyeloneuropathy (AMN): A Prospective, Multicenter, Single-Arm Clinical Trial.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400094385
Enrollment
Unknown
Registered
2024-12-20
Start date
2024-12-20
Completion date
Unknown
Last updated
2025-03-17

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

Conditions

Adrenomyeloneuropathy

Interventions

Test group:Spinal Cord Stimulation(SCS)

Sponsors

The First Affiliated Hospital of Army Medical University
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
22 Years to 50 Years

Inclusion criteria

Inclusion criteria: 1. Conforming to the diagnostic criteria of AMN, with a definite genetic testing report, and complicated by lower limb motor function disorders; 2. Age: 22-50 years old, male; 3. Capable of normal communication and able to complete scale tests independently (as determined by on-site scale tests); 4. Willing to participate in this study after giving informed consent; 5. The muscle tone of the patient's bilateral lower extremities was elevated.

Exclusion criteria

Exclusion criteria: 1.Other inherited diseases; 2.Other severe central nervous system diseases; 3.History of brain surgery; 4.Psychiatric and psychological diseases such as depression and anxiety; 5.The presence of metallic foreign bodies or prostheses (such as cardiac pacemakers, insulin pumps) in the body, claustrophobia, and other contraindications for MRI; 6.Informed consent was not obtained; 7.Unable to tolerate MRI-related examinations; 8.Received anticoagulant, antispasmodic or antiepileptic drug therapies throughout the entire study period; 9.Postoperative wound infection; 10.Other motor disorders, spinal cord pathologies, fractures, osteoarthritis, amputations, scoliosis and other movement-affecting diseases.

Design outcomes

Primary

MeasureTime frame
six minutes walk test.;

Secondary

MeasureTime frame
Discomfort and pain.;Adverse event.;Spinal cord MRI;Stool scoring (Wexner Incontinence Scale, Bristol Stool Scale (BSFS));The degree of improvement in electrophysiological indicators of the muscles in the affected limbs.;Urodynamic examination;Evaluation of erectile function (International Index of Erectile Function-5 (IIEF-5) score);Somatosensory evoked potential, visual evoked potential, auditory evoked potential, motor evoked potential.;Motion capture (gait test);Short Physical Performance Battery (SPPB);Very-long-chain fatty acid (VLCFA) detection.;Cerebrospinal fluid (CSF) testing;Cranial MRI;Fugl-Meyer Assessment Scale of Motor Function;

Countries

China

Contacts

Public ContactLiang Tan

The First Affiliated Hospital of Army Medical University

tracy200712@hotmai.com+86 23 68754277

Outcome results

None listed

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