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A randomized controlled trial of pBFS-guided iTBS at different doses in the treatment of upper limb motor disorders after stroke

A randomized controlled trial of pBFS-guided iTBS at different doses in the treatment of upper limb motor disorders after stroke

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300075555
Enrollment
Unknown
Registered
2023-09-08
Start date
2023-09-08
Completion date
Unknown
Last updated
2023-09-11

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

Conditions

stroke

Interventions

group 1:600 pulses sham iTBS +15 minutes rest +600 pulses sham iTBS +15 minutes rest +600 pulses active iTBS
group 2:600 pulses sham iTBS +15 minutes rest +600 pulses active iTBS +15 minutes rest +600 pulses active iTBS
group 3:600 pulses active iTBS +15 minutes rest +600 pulses active iTBS +15 minutes rest +600 pulses active iTBS
group 4:600 pulses sham iTBS +15 minutes rest +600 pulses sham iTBS +15 minutes rest +600 pulses sham iTBS

Sponsors

China Rehabilitation Research Center, Beijing Bo'ai Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
35 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1: First onset or past onset without significant sequelae (pre-stroke modified Rankin Scale score (mRS) =1); 2: Meet the diagnostic criteria for ischemic or hemorrhagic stroke; 3: Course of disease 1-6 months; 4: Age 35-75 years old; 5: Upper limb motor dysfunction caused by unilateral hemispheric stroke (the affected hand or upper limb Brunnstrom stage is between stage ? and stage ?, including stage ? and stage ?); 6: Who understands the trial and signs the informed consent.

Exclusion criteria

Exclusion criteria: 1: The presence of bilateral hemispherical or subtentorial lesions resulting in stroke, brain tumor, brain trauma, fracture and other diseases resulting in neurological impairment, upper limb limitation, mutilation, joint swelling, contracture, severe pain or other hand disorders; 2: MAS scores of shoulder, elbow, wrist and finger muscle tension on the affected side were =3; 3: There are contraindications for MRI scanning such as claustrophobia, and contraindications for TMS therapy; 4: A history of epilepsy; 5: Patients with severe heart, lung, liver, kidney and other systemic diseases that cannot be controlled by conventional drugs are found through laboratory tests and examinations; 6: Patients with severe aphasia (NIHSS speech item =2 points), dyslexia (NIHSS phonology item =2 points), cognitive impairment (MMSE score =20 points), deafness, etc., and unable to cooperate with treatment and evaluation 7: Is participating in other clinical research trials.

Design outcomes

Primary

MeasureTime frame
Fugl-Meyer Motor Assessment Scale-Upper Extremity ;

Secondary

MeasureTime frame
Wolf Motor Function Test ;Grip Strength;Modified Barthel Index ;Stroke Impact Scale ;

Countries

China

Contacts

Public ContactQianqian Chi

Beijing Bo'ai Hospital

bluesky1984@163.com+86 134 8873 1765

Outcome results

None listed

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