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tTIs Brain Stimulation Trial for Consciousness Disorders

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Summary

NIH has registered clinical trial NCT07539740 evaluating theta-burst patterned temporal interference stimulation (tTIs) versus sham stimulation for improving awareness in patients with disorders of consciousness (DoC). The randomized controlled study involves 10 sessions over 5 days with EEG monitoring and a 6-month follow-up period.

“Researchers will compare a group receiving active tTIs to a group receiving a "sham" stimulation (a look-alike stimulation that delivers no real current) to see if the real stimulation works better.”

NIH , verbatim from source
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What changed

The document registers a new clinical trial on ClinicalTrials.gov, not a regulatory action. The trial will randomize participants with disorders of consciousness to receive active tTIs or sham stimulation twice daily for 5 consecutive days, assessing outcomes via EEG and clinical exams before and after treatment, with phone follow-up at 1, 3, and 6 months.

Affected parties include clinical investigators and healthcare providers conducting or referring patients for disorders of consciousness research. The trial registration itself imposes no compliance obligations on external parties beyond standard clinical trial reporting requirements.

Archived snapshot

Apr 21, 2026

GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.

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Effectiveness of tTIs for Improving Consciousness in Patients With DoC

N/A NCT07539740 Kind: NA Apr 20, 2026

Abstract

The goal of this clinical trial is to learn if a new type of brain stimulation called theta-burst patterned temporal interference stimulation (tTIs) works to improve awareness in people with disorders of consciousness (DoC). The main questions it aims to answer are:

  1. Does tTIs help people with disorders of consciousness show more signs of awareness?
  2. Does tTIs improve the brain's ability to process information and connect different brain areas? Is tTIs safe and easy for people with disorders of consciousness to tolerate? Researchers will compare a group receiving active tTIs to a group receiving a "sham" stimulation (a look-alike stimulation that delivers no real current) to see if the real stimulation works better.

Participants will:Receive either active tTIs or sham stimulation twice a day for 5 consecutive days (total of 10 sessions). Undergo brain activity tests (EEG) and physical exams to check their level of awareness before and after the 5 days of treatment. Have their progress followed by researchers through phone calls at 1, 3, and 6 months after the treatment ends.

Conditions: Disorders of Consciousness, Vegetative State, Minimally Conscious State

Interventions: Theta-burst Patterned Temporal Interference Stimulation (tTIs), Sham Temporal Interference Stimulation

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Last updated

Classification

Agency
NIH
Published
April 20th, 2026
Instrument
Notice
Branch
Executive
Legal weight
Non-binding
Stage
Final
Change scope
Minor
Docket
NCT07539740

Who this affects

Applies to
Clinical investigators Healthcare providers Patients
Industry sector
6211 Healthcare Providers
Activity scope
Clinical trial registration Brain stimulation research Consciousness disorder treatment
Geographic scope
United States US

Taxonomy

Primary area
Healthcare
Operational domain
Clinical Operations
Compliance frameworks
GxP
Topics
Public Health Medical Devices

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