An interventional study of Implant in Quadriplegia, Amputations and Spinal Cord Injuries (SCI), sponsored by Shanghai StairMed Technology Co., Ltd.. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-04-25.
Sponsored by Shanghai StairMed Technology Co., Ltd. · Not applicable, Interventional, and Device feasibility
The objective of this study is to evaluate the safety and efficacy of minimally invasive, wireless brain-machine interface system (WRS) in patients with paralysis (resulting from spinal cord injuries, brainstem strokes, amyotrophic lateral sclerosis, or other motor neuron diseases causing complete or incomplete quadriplegia) or bilateral upper limb amputations. By leveraging brain-machine interface alternative technology, participants can use brain signals to control external devices (such as moving cursors, wheelchairs, robotic arms, WeChat Mini Programs, and other physical assistive devices), thereby improving their motor function and quality of life.
The objective of this study is to evaluate the safety and efficacy of minimally invasive, wireless brain-machine interface system (WRS) in patients with paralysis (resulting from spinal cord injuries, brainstem strokes, amyotrophic lateral sclerosis, or other motor neuron diseases causing complete or incomplete quadriplegia) or bilateral upper limb amputations. By leveraging brain-machine interface alternative technology, participants can use brain signals to control external devices (such as moving cursors, wheelchairs, robotic arms, WeChat Mini Programs, and other physical assistive devices), thereby improving their motor function and quality of life.
222 studies on the registry are indexed under Quadriplegia; 75 are open to participants now.
This study's planned enrollment of 5 is below the median of 15 across 193 interventional studies indexed under Quadriplegia.
Browse Quadriplegia studies →Shanghai StairMed Technology Co., Ltd. is the lead sponsor of 4 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Implantation of the device and follow-up
Device: Implant
Implantation of the device and follow-up
Adverse events
The incidence of adverse events associated with the device or surgical procedure
Time frame: Within 6 months after implantation
WRS Efficacy Assessment- Accuracy
Validation of motor function improvement through cursor control performance metrics: the accuracy of of task list (number of correct items/ number of all items), the higher the better.
Time frame: 6 months after the implantation
WRS Efficacy Assessment- Path efficiency
Validation of motor function improvement is demonstrated through cursor control performance metrics, particularly path efficiency (the ratio of optimal to actual movement path). Higher values indicate better motor control performance.
Time frame: 6 months after the implantation
WRS Efficacy Assessment- Time consumption
Motor function improvement is validated through cursor control performance metrics, particularly time consumption (total task completion duration). Shorter durations indicate superior motor performance.
Time frame: 6 months after the implantation
Neurological Recovery Assessment
The International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) scale was used to evaluate overall neurological status. The higher the scale score, the better the overall neurological status.
Time frame: 3, 15, 30, 90, 180 days after implantation
Changes in Quality of Life
Variations in the MOS item short from health survey (SF-36) scores were evaluated during both the main study period and long-term follow-up phase (comparing baseline to 6-month post-implantation assessments). The score values directly reflect health status - higher scores indicate better functional outcomes and superior quality of life.
Time frame: 3, 15, 30, 90, 180 days after implantation
Changes in Cognitive Performance
Variations in Montreal Cognitive Assessment (MoCA) scores scores were evaluated during both the main study period and long-term follow-up phase (comparing baseline to 6-month post-implantation assessments). Elevated scores are associated with improved cognitive function.
Time frame: 3, 15, 30, 90, 180 days after implantation
Changes in Psychological Status
Variations in Patient Health Questionnaire (PHQ-9) scores were evaluated during both the main study period and long-term follow-up phase (comparing baseline to 6-month post-implantation assessments). Higher scores indicate poorer psychological status.
Time frame: 3, 15, 30, 90, 180 days after implantation
Changes in Anxiety Status
Variations in Hamilton Anxiety Rating Scale (HAMA) scores were evaluated during both the main study period and long-term follow-up phase (comparing baseline to 6-month post-implantation assessments). Higher scores indicate poorer psychological status.
Time frame: 3, 15, 30, 90, 180 days after implantation
Changes in Depression Status
Variations in Hamilton Depression Rating Scale (HAMD) scores were evaluated during both the main study period and long-term follow-up phase (comparing baseline to 6-month post-implantation assessments). Higher scores indicate poorer psychological status.
Time frame: 3, 15, 30, 90, 180 days after implantation
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Apr 2025; primary completion for Apr 2027, 24 months later.
Of 97 interventional studies with no phase under Quadriplegia, half reached primary completion within 41 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 309. This study's planned 24 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
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Shanghai StairMed Technology Co., Ltd.