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

NCT ID: NCT06851156

Last Updated: 2025-04-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-07

Study Completion Date

2025-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Disorders of Consciousness Severe Brain Injury Unresponsive Wakefulness Syndrome Minimally Conscious State

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Transcranial Temporal Interference Stimulation

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

Group Type EXPERIMENTAL

tTIS

Intervention Type DEVICE

CM-pf tTIS

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

tTIS

CM-pf tTIS

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Xijing Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

wen Jiang, phD

Role: PRINCIPAL_INVESTIGATOR

Xijing Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Xijing Hospital

Xi'an, Shaanxi, China

Site Status NOT_YET_RECRUITING

Xijing Hospital

Xi'an, Shaanxi, China

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Gengyao Hu

Role: CONTACT

86-15399059833

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Gengyao Hu

Role: primary

86-029-84771794

chairman of committee

Role: primary

86-029-84771794

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

KY20242231jiangwen

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.