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Non-invasive Temporal Interference Stimulation for Post-stroke Dysfunction: A Study of Therapeutic Efficacy and Underlying Mechanisms

Non-invasive Temporal Interference Stimulation for Post-stroke Dysfunction: A Study of Therapeutic Efficacy and Underlying Mechanisms

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600128824
Enrollment
Unknown
Registered
2026-07-27
Start date
2026-08-15
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

stroke

Interventions

Dentate Nucleus tTIS Group:Received tTIS intervention targeting the dentate nucleus, 20 minutes per session, 6 days per week, for a total of 12 sessions.
M1 tTIS Group:Received tTIS intervention targeting the primary motor cortex (M1), 20 minutes per session, 6 days per week, for a total of 12 sessions.
Sham tTIS Group:Electrode placement and procedural protocols were identical to those of the active stimulation group, except that current was delivered only briefly at the beginning and end of the ses

Sponsors

The Seventh Affiliated Hospital of Sun Yat-sen University (Shenzhen)
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Meets the diagnostic criteria for stroke (including cerebral hemorrhage and cerebral infarction) established by the Fourth National Conference on Cerebrovascular Diseases of China. 2. First-ever stroke episode, confirmed by cranial CT or MRI as cerebral hemorrhage or cerebral infarction, with disease duration =1 month. 3. Aged 18–80 years (inclusive), regardless of gender. 4. Stable vital signs. 5. Written informed consent obtained from all patients. 6. Assessed during the screening period by raters who have undergone inter-rater reliability training, with the Brunnstrom stage of the affected upper limb ranging from II to V.

Exclusion criteria

Exclusion criteria: 1. Subjects with cranial defects; 2. Presence of acute or unstable cerebral hemorrhage, large-area cerebral infarction with significant mass effect, active central nervous system infection, or history of epilepsy/epileptiform discharges on EEG; 3. Received electroconvulsive therapy, deep brain stimulation, transcranial magnetic stimulation, or vagus nerve stimulation within the past 7 days; 4. Contraindications for MRI scanning, such as metallic or electronic devices in the body (intracranial metallic foreign bodies, cochlear implants, cardiac pacemakers, etc.); 5. Currently pregnant or lactating, or having plans for pregnancy or childbirth during the trial period; 6. Currently participating in other clinical interventional trials; 7. Other circumstances deemed by the investigator as unsuitable for participation in this trial.

Design outcomes

Primary

MeasureTime frame
the score of Fugl-Meyer Assessment of Upper Extremity;

Secondary

MeasureTime frame
the score of Action Research Arm Test;the score of Montreal Cognitive Assessment;Functional Connectivity;Amplitude of Low-Frequency Fluctuation;Regional Homogeneity;Fractional Anisotropy;Brain Symmetry Index;

Countries

China

Contacts

Public ContactQiang Lin

The Seventh Affiliated Hospital of Sun Yat-sen University (Shenzhen)

linqiang@sysush.com+86 189 2249 7674

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Aug 10, 2026