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Study on the Mechanism of Transcranial Time-Interfering Electrical Stimulation on Functional Improvement and Neural Plasticity after Brain Injury: Clinical Research Protocol

Study on the Mechanism of Transcranial Time-Interfering Electrical Stimulation on Functional Improvement and Neural Plasticity after Brain Injury: Clinical Research Protocol

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500101230
Enrollment
Unknown
Registered
2025-04-22
Start date
2025-04-30
Completion date
Unknown
Last updated
2025-04-28

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

Conditions

stroke

Interventions

Intervention group:Conventional rehabilitation therapy combined with deep tTIs stimulation
Control group:Conventional rehabilitation therapy combined with deep sham tTIs stimulation

Sponsors

The Fourth Affiliated Hospital of Soochow University (Suzhou Dushu Lake Hospital)
Lead Sponsor

Eligibility

Sex/Gender
All
Age
30 Years to 75 Years

Inclusion criteria

Inclusion criteria: (1) The first onset of the disease met the diagnostic criteria for cerebral infarction or cerebral hemorrhage stipulated in "Key Points for Diagnosis of Various Major Cerebrovascular Diseases in China" by the Chinese Society of Neurology of the Chinese Medical Association in 2019. (2) Age range: 30 - 75 years old. (3) Stable condition without severe complications. (4) Stroke patients with the first onset within 2 weeks to 6 months after the onset of the disease. (5) All have unilateral upper limb motor dysfunction, at Brunnstrom II - IV stages of the upper limbs. (6) Clear consciousness, able to communicate normally, and can cooperate with rehabilitation treatment. (7) Voluntary participation in this clinical trial and signing the informed consent form.

Exclusion criteria

Exclusion criteria: (1) Patients with unstable vital signs and unable to undergo research; (2) Patients with increased intracranial pressure and acute stroke patients; (3) Patients with metallic implants in the brain, pacemakers or cochlear implants; (4) Patients under deep sedation caused by general anesthetics (such as propofol) or central acting sedatives (such as benzodiazepines, opioids); (5) Patients with frequent arrhythmias and frequent epilepsy; (6) Patients with a history of mental illness, drug abuse and alcoholism; (7) Patients undergoing other neuroregulation treatments (such as transcranial magnetic stimulation).

Design outcomes

Primary

MeasureTime frame
Fugl-Meyer Assessment of Motor Function (FMA-UE);

Secondary

MeasureTime frame
Wolf Motor Function Test Scale (WMFT);Modified Barthel Index, MBI;fMRI;EEG;fNIRS;sEMG;

Countries

China

Contacts

Public ContactMin Su

The Fourth Affiliated Hospital of Soochow University (Suzhou Dushu Lake Hospital)

sumin@suda.edu.cn+86 177 1266 1015

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026