Epidural Spinal Cord Stimulation for Lower-limb Impairment in Adrenomyeloneuropathy
NCT ID: NCT06796920
Last Updated: 2025-01-28
Study Results
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Basic Information
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RECRUITING
NA
10 participants
INTERVENTIONAL
2025-02-10
2027-10-31
Brief Summary
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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 in the iliac region, and use electrical pulses to stimulate the conduction of sensory neurons in the posterior column and posterior horn of the spinal cord for treatment, which can achieve the goal of controlling pain. In addition, SCS has also conducted research on the recovery of lower limb function in paraplegic patients and upper limb function in post-stroke hemiplegic patients, and has improved corresponding motor dysfunction to a certain extent. Spinal cord stimulation may be a potential treatment for motor dysfunction in AMN. Based on the above, this study attempts to evaluate the efficacy of SCS in treating lower limb muscle tone and movement disorders in AMN patients, and explore the potential therapeutic effects and related mechanisms of SCS on AMN.
In this study, 10 AMN patients will be recruited. After enrollment, preoperative evaluation will be conducted. After preliminary assessment of motor function, neurological evaluation, and other related examinations, lumbar spinal nerve stimulators and pulse generators were implanted in our hospital. After the implantation surgery is completed, depending on the patient's recovery status, they will be transferred to various centers for subsequent rehabilitation treatment within one to two weeks, and then turned on for treatment. Before starting up, a second corresponding inspection and evaluation will be conducted. The third and fourth corresponding inspections and evaluations will be conducted one week and four weeks after startup, respectively. The patient will be discharged 4 weeks after starting up, and then return to the hospital for the fifth and sixth corresponding examinations and evaluations at 4 weeks and 6 months after discharge. Evaluate the effectiveness and safety of SCS in improving lower limb motor dysfunction in AMN patients through statistical analysis.
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Detailed Description
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Spinal Cord Stimulation (SCS) involves implanting a thin electrode (either strip-shaped or needle-shaped) into the epidural space within the spinal canal at the corresponding spinal segments, adjacent to the posterior columns of the spinal cord. The electrode is then connected to a nerve stimulator implanted subcutaneously in the iliac region, and electrical pulses are used to stimulate the conduction of the posterior columns of the spinal cord and the sensory neurons in the posterior horns for treatment purposes. This blocks the transmission of pain signals from the spinal cord to the brain, preventing them from reaching the cerebral cortex, thereby achieving the goal of pain control. Previous studies have demonstrated that, in addition to having significant therapeutic effects in analgesia, SCS has also been investigated in aspects such as the recovery of lower limb function in paraplegia and the recovery of upper limb function in hemiplegia after stroke, and it has improved the corresponding motor dysfunctions to a certain extent. For the problem of motor dysfunction in AMN, there is currently no good treatment method, and spinal cord stimulation may serve as a potential treatment approach. Based on the above, this study attempts to further explore the potential therapeutic effect and related treatment mechanisms of SCS on AMN through evaluating the efficacy of SCS in treating motor disorders of muscle tone and strength in the lower limbs of patients with AMN.
In the study, 10 patients with AMN will be recruited. After patients are enrolled in the group, preoperative evaluations will be conducted. And after the first evaluations of motor function, neurological assessment and other relevant examinations, the implantation of lumbar spinal cord nerve stimulator and pulse generator will be carried out in our hospital. After the completion of the implantation surgery, depending on the patients' recovery status, they will be transferred to each center for subsequent rehabilitation treatment within one to two weeks, and then the electrical stimulation treatment will be initiated by turning on the device. Before turning on the device, the second corresponding examinations and evaluations will be conducted. The third and fourth corresponding examinations and evaluations will be carried out one week and four weeks after turning on the device, respectively. Patients will be discharged four weeks after turning on the device, and then return to the hospital for the fifth and sixth corresponding examinations and evaluations four weeks and six months after discharge, respectively. Through the statistical analysis of self-controlled comparison before and after the trial, the efficacy and safety of SCS in improving lower limb motor dysfunction in patients with AMN will be evaluated.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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self-controlled group
This experiment is a single-arm trial, so there is only one group, forming a self-controlled comparison before and after the Spinal cord stimulation.
Spinal cord stimulation
Upon completion of the initial assessments, a lumbar spinal cord nerve stimulator and pulse generator will be implanted. Following surgery, based on the patient's recovery status, the patient will be transferred to the respective center for rehabilitation within one to two weeks. Afterward, electrical stimulation therapy will be initiated. Stimulation should be applied at least three days per week. Each day, the total stimulation time should be between 4 and 8 hours. Stimulation Modes: Continuous Stimulation: For example, if 6 hours of stimulation are prescribed, the stimulator will run uninterrupted for 6 hours. Intermittent Stimulation: For instance, a cycle of 40 seconds on and 20 seconds off. If a total of 6 hours of active stimulation is needed, the stimulator must remain on for 9 hours in total to accommodate rest intervals.The ranges for each parameter are as follows:Stimulation Frequency: 2 Hz - 2000 Hz, Pulse Width: 20 μs - 1000 μs, Stimulation Amplitude:Voltage: 0 V - 10 v
Interventions
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Spinal cord stimulation
Upon completion of the initial assessments, a lumbar spinal cord nerve stimulator and pulse generator will be implanted. Following surgery, based on the patient's recovery status, the patient will be transferred to the respective center for rehabilitation within one to two weeks. Afterward, electrical stimulation therapy will be initiated. Stimulation should be applied at least three days per week. Each day, the total stimulation time should be between 4 and 8 hours. Stimulation Modes: Continuous Stimulation: For example, if 6 hours of stimulation are prescribed, the stimulator will run uninterrupted for 6 hours. Intermittent Stimulation: For instance, a cycle of 40 seconds on and 20 seconds off. If a total of 6 hours of active stimulation is needed, the stimulator must remain on for 9 hours in total to accommodate rest intervals.The ranges for each parameter are as follows:Stimulation Frequency: 2 Hz - 2000 Hz, Pulse Width: 20 μs - 1000 μs, Stimulation Amplitude:Voltage: 0 V - 10 v
Eligibility Criteria
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Inclusion Criteria
* 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 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.
22 Years
50 Years
MALE
No
Sponsors
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Beijing Tiantan Hospital
OTHER
Jingmen No.1 People's Hospital
OTHER
The 958th Hospital of the Chinese People's Liberation Army
UNKNOWN
Third Military Medical University
OTHER
Responsible Party
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Tan Liang
Southwest hospital
Locations
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Beijing TianTan Hospital
Beijing, Beijing Municipality, 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, Chongqing Municipality, China
the Southwest hospital
Chongqing, Chongqing Municipality, China
Jingmen No.1 People's Hospital
Jingmen, Hubei, China
Countries
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Central Contacts
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Facility Contacts
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References
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Other Identifiers
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ThirdMMU-TLiang
Identifier Type: -
Identifier Source: org_study_id
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