NCT06851156

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

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

First Submitted

Initial submission to the registry

February 18, 2025

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 28, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

April 7, 2025

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

April 9, 2025

Status Verified

February 1, 2025

Enrollment Period

9 months

First QC Date

February 18, 2025

Last Update Submit

April 6, 2025

Conditions

Disorders of ConsciousnessSevere Brain InjuryUnresponsive Wakefulness SyndromeMinimally Conscious State

Outcome Measures

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.

    From enrollment to the end of treatment at 10 days

Secondary Outcomes (2)

  • Numbers of patients with improved consciousness

    From enrollment to the end of treatment at 10 days

  • EEG changes

    From enrollment to the end of treatment at 10 days

Study Arms (1)

Transcranial Temporal Interference Stimulation

EXPERIMENTAL

tTIS is applied over the bilateral CM-pf for 10 days, once a day.

Device: tTIS

Interventions

tTISDEVICE

CM-pf tTIS

Transcranial Temporal Interference Stimulation

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Xijing Hospital

Xi'an, Shaanxi, 710032, China

NOT YET RECRUITING

Xijing Hospital

Xi'an, Shaanxi, 710032, China

RECRUITING

MeSH Terms

Conditions

Consciousness DisordersBrain InjuriesPersistent Vegetative State

Condition Hierarchy (Ancestors)

Neurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurocognitive DisordersMental DisordersBrain DiseasesCentral Nervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and InjuriesBrain Damage, ChronicUnconsciousness

Study Officials

  • wen Jiang, phD

    Xijing Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Gengyao Hu

CONTACT

86-15399059833304517021@qq.com

Study Design

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

Study Record Dates

First Submitted

February 18, 2025

First Posted

February 28, 2025

Study Start

April 7, 2025

Primary Completion

December 31, 2025

Study Completion

December 31, 2025

Last Updated

April 9, 2025

Record last verified: 2025-02

Locations

CN(2)