Epidural spinal cord stimulation for lower limb issues in a rare genetic condition

Spinal Cord Stimulation Surgery for Improving Lower Limb Motor Dysfunction in Adrenomyeloneuropathy (AMN): A Prospective, Multicenter, Single-Arm, Self-Controlled Study.

This study is testing if spinal cord stimulation can help improve movement and reduce weakness in the legs of people with a rare genetic condition called adrenomyeloneuropathy.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 10 (estimated)
• Ages: 22 Years to 50 Years
• Sex: Male
• Sponsor: Third Military Medical University (Academic / other)
• Locations: 4 sites (Beijing, Beijing Municipality and 3 other locations)
• Trial ID: NCT06796920 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the use of spinal cord stimulation (SCS) to improve lower limb motor function in patients with adrenomyeloneuropathy (AMN), a rare genetic disorder. The study involves implanting a thin electrode into the epidural space to deliver electrical pulses that stimulate sensory neurons, potentially alleviating symptoms such as muscle weakness and impaired mobility. Participants must meet specific diagnostic criteria and undergo assessments to ensure they can communicate and complete tests independently. The trial aims to provide a new therapeutic approach for a condition that currently lacks effective treatment options.

Who should consider this trial

Good fit: Ideal candidates are individuals diagnosed with adrenomyeloneuropathy who experience lower limb motor function disorders.

Not a fit: Patients with other severe central nervous system diseases or those with contraindications for MRI may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve mobility and quality of life for patients with adrenomyeloneuropathy.

How similar studies have performed: While spinal cord stimulation has been explored in other contexts, this specific application for adrenomyeloneuropathy is novel and has not been extensively tested.

Eligibility criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Where this trial is running

Beijing, Beijing Municipality and 3 other locations

• Beijing TianTan Hospital — Beijing, Beijing Municipality, China (Active_not_recruiting)
• The 958 Hospital of Chinese People's Liberation Army, The Jiangbei Campus of Southwest Hospital, The First Affiliated Hospital of Army Medical University — Chongqing, Chongqing Municipality, China (Recruiting)
• the Southwest hospital — Chongqing, Chongqing Municipality, China (Recruiting)
• Jingmen No.1 People's Hospital — Jingmen, Hubei, China (Active_not_recruiting)

Study contacts

• Study coordinator: Liang Tan, Ph,D

Conditions Adrenomyeloneuropathy Without Cerebral Involvement; Genetic Diseases; Rare Diseases; Spinal Cord Stimulation; Motor Function Recovery; Multicenter Study; Adrenomyeloneuropathy