NCT06829212

Brief Summary

The clinical trial aims to evaluate the safety and efficacy of the minimally invasive, wireless brain-machine interface system (WRS) in enabling general brain control of external devices, such as a cursor and other assistive technologies, for paralyzed and amputee patients. WRS integrates a high-throughput, ultra-flexible neural electrode with an extremely small cross-sectional size-approximately one-hundredth the diameter of a human hair. Moreover, the implantable component is fully embedded within the body, leaving no visible external traces.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4

participants targeted

Target at below P25 for not_applicable

Timeline
9mo left

Started Mar 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress62%
Mar 2025Feb 2027

First Submitted

Initial submission to the registry

February 5, 2025

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 17, 2025

Completed
12 days until next milestone

Study Start

First participant enrolled

March 1, 2025

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2027

Last Updated

March 13, 2025

Status Verified

March 1, 2025

Enrollment Period

1.9 years

First QC Date

February 5, 2025

Last Update Submit

March 10, 2025

Conditions

Complete or Incomplete Paraplegia/quadriplegiaSpinal Cord InjuryBrainstem StrokeAmyotrophic Lateral SclerosisBilateral Upper Limb Amputation

Outcome Measures

Primary Outcomes (1)

  • Device-Related Adverse Events (AE)

    Through study completion, an average of 7 months

Secondary Outcomes (7)

  • Adverse Events

    Through study completion, an average of 7 months

  • Serious Adverse Event

    Through study completion, an average of 7 months

  • BPS

    At an average of 4 to 7 months after implantation, both before and during the follow-up phases.

  • Usage Time (hours/month)

    At an average of 5 to 7 months after implantation, during the follow-up phases.

  • Accuracy

    At an average of 5 to 7 months after implantation, during the follow-up phases.

  • +2 more secondary outcomes

Study Arms (1)

Implantation

EXPERIMENTAL

Implantation of the WRS64

Device: WRS

Interventions

WRSDEVICE

WRS is a minimally invasive, wireless brain-machine interface system, consisting of a wireless implanted neural signal collector(Model: WRS64), data energy transmitter(Model: DTC01/02), and a brain function information management platform software(Model: SW01).

Implantation

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Aged 18-80 years (inclusive), any gender.
  • Diagnosed with spinal cord injury, brainstem stroke, amyotrophic lateral sclerosis, or other motor neuron diseases causing partial or complete paralysis, or bilateral upper limb amputation.
  • Diagnosis stable for at least 6 months before screening, with the condition present for at least 1 year.
  • Willing to follow the study protocol and attend all visits, with or without caregiver assistance.
  • Informed consent signed by participant and/or caregiver, with full understanding of the trial's purpose.

You may not qualify if:

  • Previous implantation of metal objects or devices (except dental implants or non-impacting implants).
  • Long-term use of anticoagulants/antiplatelets with insufficient cessation, or abnormal coagulation test results.
  • Unable to tolerate anesthesia or surgery.
  • Severe neurological disorders or brain injury leading to significant dysfunction.
  • Scalp conditions that may impair wound healing.
  • Acute or severe infections.
  • Cognitive impairment or psychiatric disorders.
  • Severe dysfunction of vital organs, malignancies, or autoimmune diseases.
  • Life expectancy under 1 year.
  • Drug or alcohol abuse.
  • Pregnant, breastfeeding, or planning pregnancy during the study.
  • Other conditions deemed unsuitable by the investigator.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Huashan Hospital Affiliated to Fudan University

Shanghai, Shanghai Municipality, 200040, China

RECRUITING

MeSH Terms

Conditions

QuadriplegiaSpinal Cord InjuriesBrain Stem InfarctionsAmyotrophic Lateral Sclerosis

Condition Hierarchy (Ancestors)

ParalysisNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsSpinal Cord DiseasesCentral Nervous System DiseasesTrauma, Nervous SystemWounds and InjuriesBrain InfarctionBrain IschemiaCerebrovascular DisordersBrain DiseasesStrokeVascular DiseasesCardiovascular DiseasesInfarctionIschemiaPathologic ProcessesNecrosisMotor Neuron DiseaseNeurodegenerative DiseasesTDP-43 ProteinopathiesNeuromuscular DiseasesProteostasis DeficienciesMetabolic DiseasesNutritional and Metabolic Diseases

Central Study Contacts

Stairmed Clinical team

CONTACT

021-80510178kongcen@stairmed.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 5, 2025

First Posted

February 17, 2025

Study Start

March 1, 2025

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

February 1, 2027

Last Updated

March 13, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)