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Individualized Cerebellar Theta Burst Stimulation for Post-Stroke Upper Limb Spasticity: A Motor Evoked Potential Classification-Based Randomized Factorial Clinical Trial

Individualized Cerebellar Theta Burst Stimulation for Post-Stroke Upper Limb Spasticity: A Motor Evoked Potential Classification-Based Randomized Factorial Clinical Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600127388
Enrollment
Unknown
Registered
2026-06-30
Start date
2026-07-01
Completion date
Unknown
Last updated
2026-07-13

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

Conditions

First-ever stroke, or previous lacunar infarction without residual sequelae

Interventions

MEP-positive + cTBS group:Conventional rehabilitation therapy + continuous cerebellar theta burst stimulation (cTBS)
MEP-negative + cTBS group:Conventional rehabilitation therapy + continuous cerebellar theta burst stimulation (cTBS)
MEP-negative + iTBS group:Conventional rehabilitation therapy + intermittent cerebellar theta burst stimulation (iTBS)
MEP-positive + iTBS group:Conventional rehabilitation therapy + intermittent cerebellar theta burst stimulation (iTBS)

Sponsors

Jinshan Hosptial of Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Age between 18 and 80 years old; 2. This is the first occurrence of stroke, or there has been lacunar cerebral infarction in the past but no sequelae remain; 3. Within 3 months of onset, and the condition has been stable in the past week; 4. Clear consciousness, no obvious cognitive impairment, and the Mini-Mental State Examination (MMSE) score is >= 24, able to cooperate with treatment and assessment; 5. Paralysis of one side of the body, the motor function assessment of the affected upper limb and hand is at the Brunnstrom stage II-IV, and the modified Asworth grade is >= 1; 6. Understand the test content and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1.Wearing a pacemaker, having intracranial or other metallic implants in the body, or having a skull defect; 2.History of epilepsy, women who are lactating or possibly pregnant; 3.Accompanied by severe systemic diseases, such as congestive heart failure, or uncontrolled hypertension or diabetes; 4.Those with pre-existing upper limb diseases affecting treatment, such as upper limb infection, joint surgery, fracture, contracture, amputation, etc; 5.Those with severe visual, hearing, or speech impairments (e.g., deaf-mute individuals), or psychiatric disorders; 6.Recent use of medications that alter cortical excitability (e.g., sedatives, antidepressants).

Design outcomes

Primary

MeasureTime frame
Modified Tardieu Scale (R1 angle);

Secondary

MeasureTime frame
Motor evoked potential (MEP elicitation status, amplitude, CMCT);Modified Barthel Index;Fugl-Meyer Upper Extremity score;

Countries

China

Contacts

Public ContactTao Feng

Jinshan Hosptial of Fudan University

181897866@qq.com+86 21 34189990

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jul 23, 2026