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The effectiveness of cerebellar vermis intermittent theta burst stimulation in improving trunk control and balance function for subacute stroke patients: a randomized controlled trial

The effect and mechanism of intermittent theta burst stimulation of cerebellar vermis on balance function in stroke patients

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200065369
Enrollment
Unknown
Registered
2022-11-03
Start date
2022-12-01
Completion date
Unknown
Last updated
2023-05-15

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

Conditions

stroke

Interventions

experimental group:cerebellar vermis iTBS + conventional physical therapy
control group:sham stimulation + conventional physical therapy

Sponsors

West China Hospital, Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. A diagnosis of an ischemic stroke according to the Diagnostic criteria of cerebrovascular diseases in China (version 2019); 2. Aged 18-65 years; 3. First-ever unilateral ischemic stroke confirmed by imaging examination; 4. Subacute stroke participants with the stroke onset ranged from 2 weeks to 6 months; 5. Having motor deficit and balance dysfunction, with the Fugl-Meyer assessment scale score for lower extremities (FMA-LE) < 34 points and BBS score < 56 points.

Exclusion criteria

Exclusion criteria: 1. Diagnosis of coexisting other neurological diseases; 2. Injury of cerebellum or brain stem; 3. Having contraindications of iTBS (e.g., history of seizures, intracranial metallic implants, microprocessor implants in the body, suffering from tumorous, and pregnancy); 4. Cognitive impairment with the mini-mental state examination (MMSE) score < 27; 5. Treatment with benzodiazepines, baclofen, antiepileptics and antidepressants.

Design outcomes

Primary

MeasureTime frame
Berg Balance Scale;Trunk Impairment Scale;

Secondary

MeasureTime frame
Smart Equitest Balance Master System;surface electromyography recording;functional near-infrared spectroscopy;Fugl-Meyer assessment scale for lower extremity;Barthel Index;

Countries

China

Contacts

Public ContactQiang Gao

West China Hospital, Sichuan University

gaoqiang_hxkf@163.com+86 18980605992

Outcome results

None listed

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