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Epidural Spinal Cord Stimulation for Lower-limb Impairment in Adrenomyeloneuropathy

RecruitingNAAges 22 Years - 50 YearsMaleThird Military Medical University
NCT06796920 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Adrenal spinal neuropathy (AMN) is a rare X-linked genetic disease caused by mutations in the ABCD1 gene, and belongs to a special type of adrenal leukodystrophy. The patient's lower limb strength is weakened, the range of motion of the ankle joint is reduced, the hip flexors are weak and affect walking, and the peripheral nerves and vibration sensation are damaged. As the condition worsens, the lower limb muscle tone changes from hyperactivity to decrease, ultimately transitioning from spastic paralysis to flaccid paralysis. At present, the treatment plan for AMN is not yet perfect, and effective therapies are urgently needed to alleviate symptoms. Spinal cord electrical stimulation (SCS) is the implantation of a thin electrode into the epidural space of the corresponding spinal segment within the spinal canal. Then connect the electrodes to a nerve stimulator implanted subcutaneously

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📋 Eligibility rules (as published)
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.
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What it tests

  • Spinal cord stimulation
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Where

4 sites
Beijing TianTan Hospital
Beijing, China
The 958 Hospital of Chinese People's Liberation Army, The Jiangbei Campus of Southwest Hospital, The First Affiliated Hospital of Army Medical University
Chongqing, China
the Southwest hospital
Chongqing, China
Jingmen No.1 People's Hospital
Jingmen, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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