Health TrialsbyHealthPanel

Transcranial Temporal Interference Stimulation In Severely Brain Injured Patients With Disorders of Consciousness

ConditionsDisorders of ConsciousnessSevere Brain InjuryUnresponsive Wakefulness SyndromeMinimally Conscious State
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorXijing Hospital

About this trial

The purpose of this academic lead study is to explore the effect of noninvasive neuromodulation of the CM-pf via tTIS for patients with disorders of consciousness.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

traumatic and nontraumatic etiology of VS/UWS or MCS according to published diagnostic criteria.

Disqualifiers

patients in coma, with less than 1 week after acute brain insult, with fluctuating diagnosis on baseline assessment, and with a metallic cerebral implant or pacemaker, and with epilepsy.

Trial design

Design model

Single group

Treatments tested in this trial

  • tTIS

    Device

    CM-pf tTIS

Treatment groups

10 Participants
are divided into 1 treatment group
Group A: Transcranial Temporal Interference StimulationExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

CRS-R total score changes

Coma Recovery Scale-Revised scale score, with score ranging from 0 to 23, was used to evaluate the consciousness condition.

Time frame
From enrollment to the end of treatment at 10 days

Secondary outcomes

1

Numbers of patients with improved consciousness

Time frame
From enrollment to the end of treatment at 10 days
2

EEG changes

EEG power spectra, Connectivity and ABCD model, etc

Time frame
From enrollment to the end of treatment at 10 days

Other outcomes

Sponsors and contacts

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

Xijing Hospital

Lead sponsor

Source ClinicalTrials.gov
Apply now