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A Prospective Multicenter Randomized Triple-Blind Three-Arm Clinical Trial of Non-Invasive Transcranial Temporal Interference Stimulation for Post-Stroke Motor Dysfunction

A Prospective Multicenter Randomized Triple-Blind Three-Arm Clinical Trial of Non-Invasive Transcranial Temporal Interference Stimulation for Post-Stroke Motor Dysfunction

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600129180
Enrollment
Unknown
Registered
2026-07-31
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

Post-Stroke Motor Dysfunction

Interventions

tTIS-VIM Group:Transcranial Temporal Interference Stimulation (tTIS) targeting the ventral intermediate nucleus of the thalamus
tTIS-M1 Group:Transcranial Temporal Interference Stimulation (tTIS) targeting the primary motor cortex

Sponsors

Jiangsu Provincie Official Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18–75 years old, any gender; 2. First-ever stroke confirmed by imaging as basal ganglia stroke; 3. Disease course >=6 months and <=2 years; 4. Fugl-Meyer Upper Extremity Score <=47 points; 5. The patient or immediate family member is capable and willing to sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Severe cardiac, pulmonary, hepatic or renal insufficiency; 2. Limb dysfunction secondary to other diseases (e.g., joint contracture); 3. Contraindications to tTIS treatment or MRI scans (e.g., intracranial metal implants, large skull defects, cardiac pacemakers; ventricular shunts are permitted for enrollment); 4. Recent grand mal epileptic seizures; 5. Poor compliance, unable to complete assessments and treatment; 6. Currently participating in another clinical trial, or enrolled in another clinical trial within 3 months prior to screening; 7. Other conditions deemed unsuitable for enrollment by the investigator.

Design outcomes

Primary

MeasureTime frame
Fugl-Meyer Upper Extremity Scale;

Secondary

MeasureTime frame
Fugl-Meyer Upper Extremity Scale;Wolf Motor Function Test;Modified Ashworth Scale;Hand Function Assessment;Incidence and severity of adverse events;

Countries

China

Contacts

Public ContactLixia Zhang

Jiangsu Provincie Official Hospital

lxzhang16@sina.com+86 139 1586 6352

Outcome results

None listed

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