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Prospective, single-center clinical study to evaluate the effectiveness of two stimulation modes of BurstDR and Tonic inspinal cord electrical stimulation for disorder of minimally chronic consciousness(EDISON Study)

Prospective, single-center clinical study to evaluate the effectiveness of two stimulation modes of BurstDR and Tonic inspinal cord electrical stimulation for disorder of minimally chronic consciousness(EDISON Study)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500106734
Enrollment
Unknown
Registered
2025-07-29
Start date
2025-08-08
Completion date
Unknown
Last updated
2025-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Minimally conscious state

Interventions

BurstDR waveform stimulation:After receiving electrical spinal cord stimulation, the surgical stimulator was programmed to adjust with BurstDR waveform stimulation and its programming parameters were
Tonic waveform stimulation:After receiving electrical spinal cord stimulation, the surgical stimulator was programmed to adjust with Tonic waveform stimulation and its programming parameters were reco

Sponsors

Nanjing Brain Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients 1. Sudden impairment of consciousness. 2. Those who have been in a state of impaired consciousness for more than 3 months and have not improved or deteriorated consciousness for more than 4 consciousness. 3. Trauma patients who have not improved or worsened their consciousness for more than 8 weeks after surgery. 4. Meets MCS diagnosis: Clinical assessment using the Coma Recovery Scale (Revised) (CRS-R), and the patient meets at least one of the items in the staring or visual tracking and pain localization assessments, with a repetition rate of >50%; Neuroelectrophysiological assessment - standard electroencephalogram (EEG) status graded as Type B or Tape C. Surgery 1. Patients who have undergone SCS short-course stimulation without response and have completed SCS phase II surgery in other hospitals or Nanjing Brain Hospital. 2. CT review after surgery without serious complications such as bleeding and infection.

Exclusion criteria

Exclusion criteria: 1. Concurrent neurodegenerative disease or life-threatening disease. 2. Epilepsy that is difficult to control with medication. 3. Patients who are exacerbated by systemic disease or are not expected to survive for a long time. 4. Spinal fracture or significant spinal stenosis. 5. Brain injury is missing more than 30%. 6. Patients who are undergoing other drug or device trials and have not completed follow-up.

Design outcomes

Primary

MeasureTime frame
Coma Recovery Scale Revised Score;Electroencephalogramnalys index (supplemented by NVX EEG peak frequency system assessment);

Secondary

MeasureTime frame
functional near-infrared spectroscopy index;Positron Emission Computed Tomography index;

Countries

China

Contacts

Public ContactZhang Wenbin

Nanjing Brain Hospital

wenbinzhang@njmu.edu.cn+86 139 1298 7036

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026