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The Temporally Interfering in Patients with Disorders of Consciousness

ConditionDisorders of Consciousness
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorZhejiang Provincial People's Hospital

About this trial

This project will help the patient recover consciousness by giving TI (temporally interfering) treatment

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Single group

Treatments tested in this trial

  • temporally interfering electrical stimulation

    Device

    temporally interfering electrical stimulation

Treatment groups

40 Participants
are divided into 1 treatment group
Group A: TIExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

CRS-R (Coma Recovery Scale-revised)

The CRS-R scale, with scores ranging from 0 to 23, can help to distinguish unresponsive arousal syndrome from micro-conscious states.

Time frame
One day before the real/sham stimulus, on the day of the first real/sham stimulus, on the day of the completion of the 10 real/sham stimuli, and 14 days after the completion of the real/sham stimulus
2

Adverse reactions

Any adverse events related to the study

Time frame
One day before the real/sham stimulus, on the day of the first real/sham stimulus, on the day of the completion of the 10 real/sham stimuli, and 14 days after the completion of the real/sham stimulus

Secondary outcomes

1

EEG

phase-locked values, α, β and other EEG power

Time frame
One day before the real/sham stimulus, on the day of the first real/sham stimulus, on the day of the completion of the 10 real/sham stimuli, and 14 days after the completion of the real/sham stimulus
2

fNIRS（functional near-infrared spectroscopy）

functional connectivity

Time frame
One day before the real/sham stimulus, on the day of the first real/sham stimulus, on the day of the completion of the 10 real/sham stimuli, and 14 days after the completion of the real/sham stimulus
3

GOS-E（Glasgow Outcome Scale - Extended）

The outcome of patients was divided into 8 grades by GOS-E, and the higher the grade, the better the prognosis.

Time frame
2 weeks, 1 month, and 3 months after the end of stimulation

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Zhejiang Provincial People's Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: