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Adrenomyeloneuropathy Without Cerebral InvolvementEPIC-AMNNCT06796920

Epidural Spinal Cord Stimulation for Lower-limb Impairment in Adrenomyeloneuropathy

A study testing Spinal cord stimulation in people with Adrenomyeloneuropathy Without Cerebral Involvement, run by Third Military Medical University at 4 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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… Read more about this study

Who is it for?
Ages 22 to 50 years, men only
What is being tested?
Spinal cord stimulation
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
4 sitesChina
Study dates
10 Feb 2025to Oct 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 22 to 50 years
  • Men only
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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;
Show all 10Show fewer
  • 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.

Trial locations and contacts

4 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Liang Tan, Ph,D contact

86-158-2354-0630

tracy200712@hotmail.com

China4 sites, 2 recruiting

  • Beijing TianTan Hospital

    Beijing, Beijing Municipality, 100070

    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, 400020

    Jianmin Zhang, MD, 86-133-6828-1637 ext. 764468212@qq.c, liangtan@tmmu.edu.cn

    Jianmin Zhang, MD

    Recruiting

  • the Southwest hospital

    Chongqing, Chongqing Municipality, 400038

    Liang Tan, MD, 86-158-2354-0630, tracy200712@hotmail.com

    Liang Tan, MD

    Recruiting

  • Jingmen No.1 People's Hospital

    Jingmen, Hubei, 448000

    Active, not recruiting

Other trials in China

About this study

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

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 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.

Read the detailed description

Adrenomyeloneuropathy (AMN) is an X-linked inherited metabolic rare disease caused by mutations in the ABCD1 gene, with an incidence rate of only 1 in 50,000. Currently, it is regarded as a special type of adrenoleukodystrophy (ALD), and AMN is the most dominant disease subtype affecting adult patients. Due to the special phenomenon of skewed X-inactivation, female heterozygotes may also have spinal cord neuropathy. Such mutations can lead to the accumulation of very long chain fatty acids (VLCFA) in the blood and organs, mainly resulting in demyelination of the central nervous system and lesions in the adrenal cortex. As the disease progresses, the strength of the lower limbs and the passive range of motion of the ankle joints of patients will gradually decline. The deterioration of hip flexor muscle weakness is closely associated with a slower walking speed and an increased degree of disability. Most patients will also experience peripheral nerve involvement and impairment of vibration sensation. Hypertonia of the lower limbs will gradually develop into a decline in both muscle strength and muscle tone, and finally progress from spastic paralysis to flaccid paralysis. However, the current commonly used treatment regimens for AMN still have deficiencies, and it is necessary to seek effective treatment methods to alleviate patients' symptoms and improve their quality of life.

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.

Being tested
Spinal cord stimulation
Keywords
Genetic Diseases, Rare Diseases, Spinal Cord Stimulation, Motor Function Recovery, Multicenter Study, Adrenomyeloneuropathy
Medical subject headings
Genetic Diseases, Inborn, Rare Diseases, Adrenoleukodystrophy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Spinal cord stimulationProcedure or surgery

    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

Study groups in NCT06796920
Study groupRoleWhat they receive
self-controlled groupExperimentalThis experiment is a single-arm trial, so there is only one group, forming a self-controlled comparison before and after the Spinal cord stimulation.
Receives: Procedure: Spinal cord stimulation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 6-minute walk test (6MWT)

    This evaluation is based on the walking distance that patients cover in six minutes when walking as fast as possible along a straight corridor, which is a indicator for assessing the lower limb motor function.

    Measured: Preoperative stage; One week after surgery; One week after device activation; Four weeks after device activation; Four weeks after discharge from hospital; Six months after discharge from hospital

Secondary outcomes (17)

  1. Adverse event

    Record the adverse reactions related to spinal cord stimulation (SCS), such as nerve injury, infection, hemorrhage, edema, poor wound healing, etc. These manifestations reflect the safety of spinal cord stimulation treatment.

    Measured: One week after surgery; One week after device activation; Four weeks after device activation; Four weeks after discharge from hospital; Six months after discharge from hospital; One year after discharge from hospital.

  2. Discomfort and pain.

    This assessment is based on the fact that after each stimulus training, patients need to use the Numerical Rating Scale (NRS) to report the degree of discomfort they perceive: NRS versions 0-10 were used in this study. Use 0-10 to represent different degrees of pain: 0 represents no pain, 1-3 represents mild pain (pain does not affect sleep), 4-6 represents moderate pain (mild affects sleep), 7-9 represents severe pain (inability to fall asleep or waking up during sleep), and 10 represents severe pain.

    Measured: Preoperative stage; One week after surgery; One week after device activation; Four weeks after device activation; Four weeks after discharge from hospital; Six months after discharge from hospital; One year after discharge from hospital.

  3. Spinal cord and brain MRI

    This evaluation is based on the atrophy volume of each segment of the spinal cord and brain analyzed by artificial intelligence segmentation, so as to assess the progression degree of spinal cord and brain white matter injury in patients.

    Measured: Preoperative stage; One week after surgery; One week after device activation; Four weeks after device activation; Four weeks after discharge from hospital; Six months after discharge from hospital

  4. The degree of improvement in electrophysiological indicators of the muscles in the affected limbs

    This assessment is an objective examination of muscle electrophysiology to evaluate the recovery of the patient's motor function.

    Measured: Preoperative stage; One week after surgery; One week after device activation; Four weeks after device activation; Four weeks after discharge from hospital; Six months after discharge from hospital

  5. Qmax（The maximum flow rate）

    Qmax is the peak of a continuous, immediate uroflow rate numerical curve traced with a uroflowmetry device during voiding, suggesting a combination of bladder and urethral function during the subject's voiding. It is calculated in milliliters per second.

    Measured: Preoperative stage; One week after surgery; One week after device activation; Four weeks after device activation; Four weeks after discharge from hospital; Six months after discharge from hospital

  6. Filling bladder pressure

    Filling cystometry is a method of measuring the pressure-volume correlation of the bladder under specific media perfusion in order to understand the function of the urethra and urethra during the storage phase.

    Measured: Preoperative stage; One week after surgery; One week after device activation; Four weeks after device activation; Four weeks after discharge from hospital; Six months after discharge from hospital

  7. Urethral pressure

    Urethral pressure is the fluid pressure required just to open and close the urethra during urodynamics, and is an important indicator for evaluating the functional status of the urethra.

    Measured: Preoperative stage; One week after surgery; One week after device activation; Four weeks after device activation; Four weeks after discharge from hospital; Six months after discharge from hospital

  8. Residual urine volume

    Bladder residual urine volume is the amount of urine still remaining in the bladder after the end of urination. It is an important indicator for assessing bladder voiding function. Under normal circumstances, the residual urine volume in a healthy adult should be less than 10 milliliters. When the residual urine volume exceeds 10 milliliters, it may indicate impaired bladder voiding function.

    Measured: Preoperative stage; One week after surgery; One week after device activation; Four weeks after device activation; Four weeks after discharge from hospital; Six months after discharge from hospital

  9. Evaluation of erectile function (International Index of Erectile Function-5 (IIEF-5) score)

    This evaluation is based on the International Index of Erectile Function (IIEF) scores. The total score of the IIEF-5 ranges from 0 to 25, and a higher score indicates that the patient has better erectile function.

    Measured: Preoperative stage; One week after surgery; One week after device activation; Four weeks after device activation; Four weeks after discharge from hospital; Six months after discharge from hospital

  10. Stool scoring (Wexner Incontinence Scale, Bristol Stool Scale (BSFS))

    This evaluation is based on the Wexner Incontinence Scale and the Bristol Stool Form Scale. The Wexner Incontinence Scale is a scale used to assess the severity of defecation in patients and is applicable to patients with fecal incontinence caused by various reasons. The Bristol Stool Form Scale is a classification system based on the shape of feces, which is used to evaluate the characteristics of feces and possible health problems.

    Measured: Preoperative stage; One week after surgery; One week after device activation; Four weeks after device activation; Four weeks after discharge from hospital; Six months after discharge from hospital

  11. Somatosensory evoked potential, visual evoked potential, auditory evoked potential, motor evoked potential.

    Evoked potentials are generated by stimulating any structures related to sensory organs, nerves, pathways or systems, resulting in measurable potential changes in the central nervous system. They can be used to assess the functional integrity of the central and peripheral nervous systems.

    Measured: Preoperative stage; One week after surgery; One week after device activation; Four weeks after device activation; Four weeks after discharge from hospital; Six months after discharge from hospital

  12. Motion capture (gait test)

    This evaluation is based on the range of motion of joints and spatio-temporal parameters of gait.

    Measured: Preoperative stage; One week after surgery; One week after device activation; Four weeks after device activation; Four weeks after discharge from hospital; Six months after discharge from hospital

  13. Short Physical Performance Battery (SPPB)

    This evaluation is based on a comprehensive score, which includes walking speed, balance tests and the chair stand test. The higher the score is, the better the physical condition will be.

    Measured: Preoperative stage; One week after surgery; One week after device activation; Four weeks after device activation; Four weeks after discharge from hospital; Six months after discharge from hospital

  14. Very-long-chain fatty acid (VLCFA)

    This evaluation is based on detecting the levels of very-long-chain fatty acids (VLCFAs) in plasma and cerebrospinal fluid, analyzing the specific metabolic changes of this disease, so as to conduct disease monitoring and efficacy evaluation.

    Measured: Preoperative stage; One week after surgery; One week after device activation; Four weeks after device activation; Four weeks after discharge from hospital; Six months after discharge from hospital

  15. Cerebrospinal fluid (CSF)

    The cerebrospinal fluid was examined by means of biochemical, transcriptomic, epigenetic and other methods.

    Measured: Preoperative stage; One week after surgery; One week after device activation; Four weeks after device activation; Four weeks after discharge from hospital; Six months after discharge from hospital

  16. Fugl-Meyer assessment scale (FMA)

    The Fugl-Meyer Assessment (FMA) is a method used to evaluate the motor function status of patients of various ages. It is applicable in both clinical settings and research to determine the severity of diseases, describe motor recovery, and formulate plans as well as evaluate treatments.

    Measured: Preoperative stage; One week after surgery; One week after device activation; Four weeks after device activation; Four weeks after discharge from hospital; Six months after discharge from hospital

  17. Cranial MRI

    Utilize 3T and 7T magnetic resonance imaging to examine the resting state, occipital radiation spectroscopy, quantitative susceptibility mapping (QSM), and subvoxel imaging of the enrolled patients.

    Measured: Preoperative stage; One week after surgery; One week after device activation; Four weeks after device activation; Four weeks after discharge from hospital; Six months after discharge from hospital

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jan 2025
  2. Study start10 Feb 2025 (estimated)
  3. Primary completionJun 2027 (estimated)
  4. Study completionOct 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
10 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06796920
Sponsor's protocol ID
ThirdMMU-TLiang
Acronym
EPIC-AMN
Status last verified
Jan 2025
First submitted
6 Jan 2025
Last updated
28 Jan 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Shanthanna H, Eldabe S, Provenzano DA, Bouche B, Buchser E, Chadwick R, Doshi TL, Duarte R, Hunt C, Huygen FJPM, Knight J, Kohan L, North R, Rosenow J, Winfree CJ, Narouze S. Evidence-based consensus guidelines on patient selection and trial stimulation for spinal cord stimulation therapy for chronic non-cancer pain. Reg Anesth Pain Med. 2023 Jun;48(6):273-287. doi: 10.1136/rapm-2022-104097. Epub 2023 Mar 30.

    PubMed 37001888

  • North R, Shipley J, Prager J, Barolat G, Barulich M, Bedder M, Calodney A, Daniels A, Deer T, DeLeon O, Drees S, Fautdch M, Fehrenbach W, Hernandez J, Kloth D, Krames ES, Lubenow T, North R, Osenbach R, Panchal SJ, Sitzman T, Staats P, Tremmel J, Wetzel T, American Academy of Pain Medicine. Practice parameters for the use of spinal cord stimulation in the treatment of chronic neuropathic pain. Pain Med. 2007 Dec;8 Suppl 4:S200-75. doi: 10.1111/j.1526-4637.2007.00388.x. No abstract available.

    PubMed 17995571

  • Powell MP, Verma N, Sorensen E, Carranza E, Boos A, Fields DP, Roy S, Ensel S, Barra B, Balzer J, Goldsmith J, Friedlander RM, Wittenberg GF, Fisher LE, Krakauer JW, Gerszten PC, Pirondini E, Weber DJ, Capogrosso M. Epidural stimulation of the cervical spinal cord for post-stroke upper-limb paresis. Nat Med. 2023 Mar;29(3):689-699. doi: 10.1038/s41591-022-02202-6. Epub 2023 Feb 20.

    PubMed 36807682

  • Kandhari S, Sharma D, Samuel S, Sharma G, Majumdar P, Edgerton VR, Gad P. Epidural Spinal Stimulation Enables Global Sensorimotor and Autonomic Function Recovery After Complete Paralysis: 1st Study From India. IEEE Trans Neural Syst Rehabil Eng. 2022;30:2052-2059. doi: 10.1109/TNSRE.2022.3158393. Epub 2022 Jul 27.

    PubMed 35271446

  • Wagner FB, Mignardot JB, Le Goff-Mignardot CG, Demesmaeker R, Komi S, Capogrosso M, Rowald A, Seanez I, Caban M, Pirondini E, Vat M, McCracken LA, Heimgartner R, Fodor I, Watrin A, Seguin P, Paoles E, Van Den Keybus K, Eberle G, Schurch B, Pralong E, Becce F, Prior J, Buse N, Buschman R, Neufeld E, Kuster N, Carda S, von Zitzewitz J, Delattre V, Denison T, Lambert H, Minassian K, Bloch J, Courtine G. Targeted neurotechnology restores walking in humans with spinal cord injury. Nature. 2018 Nov;563(7729):65-71. doi: 10.1038/s41586-018-0649-2. Epub 2018 Oct 31.

    PubMed 30382197

  • Rowald A, Komi S, Demesmaeker R, Baaklini E, Hernandez-Charpak SD, Paoles E, Montanaro H, Cassara A, Becce F, Lloyd B, Newton T, Ravier J, Kinany N, D'Ercole M, Paley A, Hankov N, Varescon C, McCracken L, Vat M, Caban M, Watrin A, Jacquet C, Bole-Feysot L, Harte C, Lorach H, Galvez A, Tschopp M, Herrmann N, Wacker M, Geernaert L, Fodor I, Radevich V, Van Den Keybus K, Eberle G, Pralong E, Roulet M, Ledoux JB, Fornari E, Mandija S, Mattera L, Martuzzi R, Nazarian B, Benkler S, Callegari S, Greiner N, Fuhrer B, Froeling M, Buse N, Denison T, Buschman R, Wende C, Ganty D, Bakker J, Delattre V, Lambert H, Minassian K, van den Berg CAT, Kavounoudias A, Micera S, Van De Ville D, Barraud Q, Kurt E, Kuster N, Neufeld E, Capogrosso M, Asboth L, Wagner FB, Bloch J, Courtine G. Activity-dependent spinal cord neuromodulation rapidly restores trunk and leg motor functions after complete paralysis. Nat Med. 2022 Feb;28(2):260-271. doi: 10.1038/s41591-021-01663-5. Epub 2022 Feb 7.

    PubMed 35132264

  • Luo S, Xu H, Zuo Y, Liu X, All AH. A Review of Functional Electrical Stimulation Treatment in Spinal Cord Injury. Neuromolecular Med. 2020 Dec;22(4):447-463. doi: 10.1007/s12017-019-08589-9. Epub 2020 Jan 8.

    PubMed 31916220

  • Moraud EM, Capogrosso M, Formento E, Wenger N, DiGiovanna J, Courtine G, Micera S. Mechanisms Underlying the Neuromodulation of Spinal Circuits for Correcting Gait and Balance Deficits after Spinal Cord Injury. Neuron. 2016 Feb 17;89(4):814-28. doi: 10.1016/j.neuron.2016.01.009. Epub 2016 Feb 4.

    PubMed 26853304

  • Rock AK, Truong H, Park YL, Pilitsis JG. Spinal Cord Stimulation. Neurosurg Clin N Am. 2019 Apr;30(2):169-194. doi: 10.1016/j.nec.2018.12.003. Epub 2019 Feb 18.

    PubMed 30898269

  • Dooley DM, Sharkey J, Keller W, Kasprak M. Treatment of demyelinating and degenerative diseases by electro stimulation of the spinal cord. Med Prog Technol. 1978 Nov 13;6(1):1-14.

    PubMed 310508

  • Shealy CN, Mortimer JT, Reswick JB. Electrical inhibition of pain by stimulation of the dorsal columns: preliminary clinical report. Anesth Analg. 1967 Jul-Aug;46(4):489-91. No abstract available.

    PubMed 4952225

  • Melzack R, Wall PD. Pain mechanisms: a new theory. Science. 1965 Nov 19;150(3699):971-9. doi: 10.1126/science.150.3699.971. No abstract available.

    PubMed 5320816

  • Ni Y, Liu C, Tan L. Male Carrier of X-Linked Adrenal Leukodystrophy Due to 47, XXY Karyotype. JAMA Neurol. 2024 May 1;81(5):549-550. doi: 10.1001/jamaneurol.2024.0061.

    PubMed 38436991

  • Ombrone D, Giocaliere E, Forni G, Malvagia S, la Marca G. Expanded newborn screening by mass spectrometry: New tests, future perspectives. Mass Spectrom Rev. 2016 Jan-Feb;35(1):71-84. doi: 10.1002/mas.21463. Epub 2015 May 7.

    PubMed 25952022

  • van Egmond ME, Pouwels PJ, Boelens JJ, Lindemans CA, Barkhof F, Steenwijk MD, van Hasselt PM, van der Knaap MS, Wolf NI. Improvement of white matter changes on neuroimaging modalities after stem cell transplant in metachromatic leukodystrophy. JAMA Neurol. 2013 Jun;70(6):779-82. doi: 10.1001/jamaneurol.2013.629.

    PubMed 23608771

Questions about this trial

What is this clinical trial studying?

A study testing Spinal cord stimulation in people with Adrenomyeloneuropathy Without Cerebral Involvement, run by Third Military Medical University at 4 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 28 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Liang Tan, Ph,D (86-158-2354-0630, tracy200712@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

6-minute walk test (6MWT) (time frame: Preoperative stage; One week after surgery; One week after device activation; Four weeks after device activation; Four weeks after discharge from hospital; Six months after discharge from hospital). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06796920, which also lists 23 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2025.

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