AzTrials
AzTrials

Spinal Cord Injuries (SCI)NCT07105878

Epidural Electrical Stimulation in Spinal Cord Injury

A study testing Epidural Electrical Stimulation, Standard Rehabilitation Therapy and positron emission tomography-computed tomography (PET-CT) in people with Spinal Cord Injuries (SCI), run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site 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

The goal of this clinical trial is to evaluate the safety and effectiveness of Epidural Electrical Stimulation (EES) in motor and sensory function Reconstruction in chronic spinal cord injury (SCI) patients classified as ASIA B-D. Read more about this study

Who is it for?
Ages 16 to 60 years
Conditions the study is for
Spinal Cord Injuries (SCI)
What is being tested?
Epidural Electrical Stimulation, Standard Rehabilitation Therapy and positron emission tomography-computed tomography (PET-CT)
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteChina
Study dates
1 Mar 2025to 31 Dec 2026
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 16 to 60 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • Spinal Cord Injury, ASIA B-D;
  • Spinal cord injury level above T10;
  • Diagnosed with spinal cord injury for ≥ 8 months and ≤ 36 months;
  • WISCI II score < 13;
  • No significant improvement in motor dysfunction after rehabitation over the past 2 months.
  • An expected survival period of ≥ 12 months.
  • Subjects voluntarily participate in this study, sign the informed consent form, have good compliance, cooperate with necessary postoperative rehabilitation training and tests, and assist in follow-up visits.

Who cannot join

  • Subjects with other severe organic neurological diseases, mental illnesses other than anxiety/depression.
  • Subjects with hemorrhagic diathesis or coagulation dysfunction (prothrombin time [PT] ≥ 18 seconds).
  • Subjects with a history of alcohol or drug abuse or dependence.
  • Subjects with mental retardation, cognitive dysfunction, or personality disorders.
  • Subjects with a history of electroconvulsive therapy or those requiring continuous electrotherapy.
  • Subjects with implanted cardiac pacemakers, cardioverters, or defibrillators. Expected survival period < 1 year.

Trial locations and contacts

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

Junming Zhu, Chief Physician contact

13968055768

dr.zhujunming@zju.edu.cn

Zhoule Zhu, Attending Physician contact

15168377035

doczhuzl@zju.edu.cn

China1 site, 1 recruiting

  • Second Affiliated Hospital, School of Medicine, Zhejiang University

    Hangzhou, Zhejiang, 310009

    Junming Zhu, Chief Physician, 13968055768, dr.zhujunming@zju.edu.cn

    Zhoule Zhu, Attending Physician, 15168377035, doczhuzl@zju.edu.cn

    Recruiting

Other trials in China

About this study

Official title: Epidural Electrical Stimulation for Motor and Sensory Function Reconstruction in Spinal Cord Injury

The goal of this clinical trial is to evaluate the safety and effectiveness of Epidural Electrical Stimulation (EES) in motor and sensory function Reconstruction in chronic spinal cord injury (SCI) patients classified as ASIA B-D. The main questions it aims to answer are:

Does EES treatment significantly improve motor and sensory function in patients with SCI compared to baseline? Is EES a safe intervention for this patient population? Researchers will compare participants' motor function, sensory function, and quality of life assessments before EES implantation, immediately after activation of the device, and at 1, 3, and 6 months post-implantation to evaluate the longitudinal effects of EES.

Read more

Participants will:

Undergo surgical implantation of an EES device in the epidural space. Have the EES device activated and receive personalized stimulation parameter adjustments during follow-up visits.

Complete regular motor and sensory function assessments using standardized protocols.

Participate in structured rehabilitation training sessions while using the EES device.

Report any adverse events and complete quality of life questionnaires at specified follow-up intervals.

Being tested
Epidural Electrical Stimulation, Standard Rehabilitation Therapy, positron emission tomography-computed tomography (PET-CT), Diffusion Tensor Imaging (DTI), Somatosensory Evoked Potentials (SEPs)
Keywords
Epidural Electrical Stimulation, Spinal Cord Injuries, Sensor function reconstruction, Motor function reconstruction
Medical subject headings
Spinal Cord Injuries

What participants receive

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

  • Epidural Electrical StimulationProcedure or surgery

    Epidural Electrical Stimulation (EES) is a medical technology that involves delivering controlled electrical impulses to the spinal cord through electrodes implanted in the epidural space-the area between the outermost membrane of the spinal cord (dura mater) and the vertebrae. This technique aims to modulate the activity of spinal neural networks, thereby regulating neurological functions and promoting functional recovery, particularly in individuals with spinal cord injuries or certain neurological disorders.

  • Standard Rehabilitation TherapyProcedure or surgery

    A structured, multidisciplinary rehabilitation program designed to improve motor function, mobility, and independence in participants with paralysis. The therapy typically includes physical Therapy and occupational Therapy.

  • positron emission tomography-computed tomography (PET-CT)Radiation

    PET-CT is an advanced hybrid imaging modality that combines metabolic information from positron emission tomography with anatomical details from computed tomography.

  • Diffusion Tensor Imaging (DTI)Radiation

    DTI is an advanced MRI technique that maps white matter tracts by measuring the directionality (anisotropy) and magnitude of water molecule diffusion in neural tissues. It provides quantitative metrics of fibers.

  • Somatosensory Evoked Potentials (SEPs)Procedure or surgery

    SEPs are electrophysiological responses recorded from the central or peripheral nervous system following electrical stimulation of sensory nerves. They assess the functional integrity of somatosensory pathways.

  • Motor Evoked Potentials (MEPs)Procedure or surgery

    MEPs are electrophysiological responses elicited by transcranial magnetic stimulation or electrical stimulation of the motor cortex, recorded from peripheral muscles or the spinal cord. They evaluate the integrity of corticospinal tracts.

Study groups in NCT07105878
Study groupRoleWhat they receive
Epidural Electrical Stimulation (EES) + Standard RehabilitationExperimentalParticipants receive the EES intervention combined with standard rehabilitation therapy (e.g., physical therapy, occupational therapy) for 6 months.
Receives: Procedure: Epidural Electrical Stimulation; Procedure: Standard Rehabilitation Therapy; Radiation: positron emission tomography-computed tomography (PET-CT); Radiation: Diffusion Tensor Imaging (DTI); Procedure: Somatosensory Evoked Potentials (SEPs); Procedure: Motor Evoked Potentials (MEPs)

What is being measured

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

  1. WISCI II (Walking Index for Spinal Cord Injury II)

    The WISCI II evaluates walking ability in spinal cord injury patients. It has 21 levels (0-20), with scores based on mobility aids, assistance needed, and walking distance. A score of 0 means no walking; 20 indicates independent walking over 500 meters without aids. It tracks recovery progress and helps tailor rehabilitation plans for locomotor function.

    Measured: baseline, and 1, 3, 6 monthes after surgery

  2. Functional Independence Measure (FIM)

    The Functional Independence Measure (FIM) is a widely used assessment tool designed to evaluate a person's functional status and level of independence in daily living activities, particularly among individuals with disabilities.

    FIM items are scored based on the level of assistance required to complete a task, ranging from 1 to 7 points per item.

    The FIM consists of 18 items across two domains: Motor domain (13 items): Includes activities such as eating, grooming, bathing, dressing, toileting, transfers (bed/chair, toilet, tub/shower), walking, and stair climbing. Cognitive domain (5 items): Covers communication (comprehension and expression) and social cognition (memory, problem-solving, and social interaction).

    The total score ranges from 18 to 126 points:

    ≤ 35 points: Severe dependence 36-89 points: Moderate dependence 90-119 points: Mild dependence 120-126 points: Functional independence

    Measured: baseline, and 1, 3, 6 months after surgery

Secondary outcomes (6)

  1. International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI)

    ISNCSCI is the most authoritative and widely used standard for evaluating neurological function after spinal cord injury, comprising:

    Motor Scores:

    Range:

    Upper limbs (C5-T1): 0-25 per limb (total 0-50) Lower limbs (L2-S1): 0-25 per limb (total 0-50) Total motor score: 0-100 points Higher scores indicate better motor function

    Sensory Scores:

    Light touch:

    0-2 points per dermatome (C2-S4/5) Total: 0-112 points

    Pinprick:

    0-2 points per dermatome (C2-S4/5) Total: 0-112 points Interpretation: Higher scores indicate better sensory preservation Neurological Level of Injury

    Determined by the most caudal segment with:

    ≥3/5 muscle strength (motor level) Intact sensation (sensory level) ASIA Impairment Scale (AIS)

    Grading:

    A = Complete (no motor/sensory function in S4-S5) B = Sensory incomplete C = Motor incomplete (<50% key muscles ≥3/5 below NLI) D = Motor incomplete (≥50% key muscles ≥3/5 below NLI) E = Normal

    Measured: baseline, and 1, 3, 6 monthes after surgery

  2. Modified Ashworth Scale

    The Modified Ashworth Scale (MAS) is a clinical tool used to assess muscle spasticity by grading resistance during passive movement. It scores from 0 (no tone increase) to 4 (rigid joint), with intermediate grades: 1 (slight resistance), 1+ (mild resistance through ≤50% ROM), 2 (marked resistance), and 3 (considerable resistance). Higher MAS scores (max=4) indicate worse outcomes, reflecting more severe spasticity that impairs mobility. The assessment requires standardized passive stretching at 1 joint/sec. While widely used, it shows limitations in distinguishing mild/moderate spasticity reliably.

    Measured: baseline, and 1, 3, 6 monthes after surgery

  3. Penn

    The Penn Scale is a specific assessment tool for measuring muscle spasticity. Scores range from 0 (no spasticity) to 4 (severe, rigid spasticity), with higher scores indicating more intense muscle stiffness and involuntary contractions.

    Measured: baseline, and 1, 3, 6 months after surgery

  4. Hamilton Depression Rating Scale (HAMD)

    The HAMD is a clinician-administered assessment used to measure the severity of depressive symptoms in individuals. It typically consists of 17 items, with scores based on the patient's reported feelings, behavior, and psychological state over the past week. A higher score indicates more severe depression. It is widely used to diagnose depression, evaluate treatment efficacy, and monitor symptom changes over time.

    Measured: baseline, and 1, 3, 6 monthes after surgery

  5. Hamilton Anxiety Rating Scale (HAMA)

    The HAMA is a clinician-rated scale designed to quantify the severity of anxiety symptoms. It comprises 14 items, with scores reflecting both psychic anxiety (mental agitation) and somatic anxiety (physical complaints). A higher score signifies a greater level of anxiety. It assists in diagnosing anxiety disorders, assessing their intensity, and tracking the effectiveness of therapeutic interventions.

    Measured: baseline, and 1, 3, 6 monthes after surgery

  6. Visual Analog Scale (VAS)

    The VAS Pain Score is a self-reported measure of pain intensity. It consists of a 10-cm horizontal line, anchored by "no pain" (0) on one end and "worst pain imaginable" (10) on the other. Patients mark the line to represent their current pain level, and the score is determined by measuring the distance from "no pain." It provides a simple, quick method to quantify subjective pain experiences, monitor fluctuations, and guide pain management strategies.

    Measured: baseline, and 1, 3, 6 monthes after surgery

Timeline

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

  1. First posted6 Aug 2025
  2. Study start1 Mar 2025
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Dec 2026 (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
Model description
One group of patients with spinal cord injury received EES treatment and 6 months of standardized rehabilitation therapy, while the other group received only standardized rehabilitation therapy.
Masking
None (open label)
Enrolment
10 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07105878
Sponsor's protocol ID
2025-1040
Status last verified
Jul 2025
First submitted
30 Jul 2025
Last updated
24 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Questions about this trial

What is this clinical trial studying?

A study testing Epidural Electrical Stimulation, Standard Rehabilitation Therapy and positron emission tomography-computed tomography (PET-CT) in people with Spinal Cord Injuries (SCI), run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site 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 7 inclusion and 6 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 24 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 Junming Zhu, Chief Physician (13968055768, dr.zhujunming@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

WISCI II (Walking Index for Spinal Cord Injury II) (time frame: baseline, and 1, 3, 6 monthes after surgery). The study lists 2 primary outcomes in all. 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 NCT07105878.

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 24 Apr 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in