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The effects of Theta-burst Transcranial Magnetic Stimulation over Contralesional Premotor Area and Contralesional Primary Motor Cortex on Post-stroke Spasticity in Patients with Severe Hemiplegia

The effects of Theta-burst Transcranial Magnetic Stimulation over Contralesional Premotor Area and Contralesional Primary Motor Cortex on Post-stroke Spasticity in Patients with Severe Hemiplegia

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200060885
Enrollment
Unknown
Registered
2022-06-13
Start date
2022-06-25
Completion date
Unknown
Last updated
2024-09-09

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

Conditions

stroke

Interventions

cTBS-PMA:Continuous theta burst stimulation over PMA will be provided once a day, 5 times a week for 4 weeks
cTBS-M1:Continuous theta burst stimulation over M1 will be provided once a day, 5 times a week for 4 weeks
Sham-cTBS:Sham continuous theta burst stimulation over PMA will be provided once a day, 5 times a week for 4 weeks

Sponsors

Department of Rehabilitation Medicine, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1.Age 18–80 years old, regardless of gender; 2.First unilateral stroke (cerebral infarction, primary intracerebral hemorrhage, subarachnoid hemorrhage) confirmed by MRI or CT within 6 months before enrolment; 3.Perceptible muscle spasticity with MAS score >1; 4.Severe motor impairment with the Fugl-Meyer Assessment of Upper Extremity (FMA-UE) score 0-35; 5.Failure to induce MEP in the upper extremity of the hemiplegic side; 6.Mini-Mental State Examination (MMSE) score >= 22 and compliance with the interventions; 7.Sign the informed consent.

Exclusion criteria

Exclusion criteria: 1.More than one stroke (patients with previous transient ischemic attack could participate), bilateral cerebral hemisphere lesion; 2.History of seizures or seizures after stroke, severe skull fracture; 3.Conditions unsuitable for TBS, e.g. intracranial implants, cardiac pacemakers or pregnancy, implanted drug pumps, etc.; 4.Medications that may lower the seizure threshold have been used continuously for nearly 6 months. 5.Serious impairments of heart, lung, liver, kidney, and other organs, cannot tolerate training; 6.Participation in other spasticity rehabilitation studies.

Design outcomes

Primary

MeasureTime frame
Fugl-Meyer assessment scale of the upper extremity;MAS;

Secondary

MeasureTime frame
H reflex and M response;Startle reflex;MEP;DTI;

Countries

China

Contacts

Public ContactLiu Yali

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

liuyali74@126.com+86 13886171269

Outcome results

None listed

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