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A randomized controlled trial of transcranial magnetic stimulation and enhanced external counter pulsation to improve hand function after ischemic stroke

A randomized controlled trial of transcranial magnetic stimulation and enhanced external counter pulsation to improve hand function after ischemic stroke

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-14005009
Enrollment
Unknown
Registered
2014-07-25
Start date
2014-09-20
Completion date
Unknown
Last updated
2017-05-22

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

Conditions

stroke

Interventions

Two grous:Device transcranial magnetic stimulation & enhanced external conterpulsation 10 sessions for TBS and EECP versus 10 sessions of sham therapy

Sponsors

Medicine & Therapeutics, The Chinese University of Hong Kong
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1) patients aged 18 or above; 2) first-ever ischemic subcortical stroke with onset time less than 21 days; 3) hand weakness (distal MRC 1- 5-) as a result of stroke; 4) recordable MEPs over ipsilesional hemisphere; 5) intracranial hemorrhage excluded by brain computed tomography (CT) / magnetic resonance imaging (MRI); 6) the patient or his/her legally acceptable representative is willing to provide written informed consent.

Exclusion criteria

Exclusion criteria: For TMS : 1) personal history of epilepsy; 2) metallic implants in any part of body; 3) implanted cardiac pacemaker, defibrillator, medication pump or any other implanted electronics; 4) severe skull fracture, serious head injury, history of brain or spinal cord surgery; 5) brain tumour or other significant non-ischemic brain lesion on CT/MRI; 6) administration of drugs that potentially lower seizure threshold; 7) active malignancy; 8) severe co-existing systemic diseases: eg. renal failure (creatinine more than 300 umol/L, if known), cirrhosis, severe dementia or psychosis; 9) inability to be followed up at regular interval; 10) pegnancy or breast-feeding. For ECP: 11) evidence for cardioembolic stroke such as atrial fibrillation and rheumatic heart disease; 12) sustained hypertension (systolic higher than 180mmHg or diastolic higher than 100mmHg); 13) subject has thrombocytopenia (platelet count less than 100,000/mm3); 14) evidence of arteriovenous malformation, arteriovenous fistula or aneurysm; 15) evidence of diabetic retinopathy.

Design outcomes

Primary

MeasureTime frame
upper limb Fugl-Meyer Assessment (FMA);

Secondary

MeasureTime frame
FMA, National Institutes of Health Stroke Scale (NIHSS), modified-Rankin Scale (mRS);;grip strength, lateral pinch grip, purdue pegboard test;;TMS measures including RMT, AMT, MEPs;

Countries

China

Contacts

Public ContactKa Sing WONG

Division of Neurology, Dept of Medicine and Therapeutics, PWH

ks-wong@cuhk.edu.hk+852 2632 3877

Outcome results

None listed

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