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Trial History Detail on 2016-08-30

CUHK_CCT00425

2014-07-23

Prospective

CRE-2013.674-T

Division of Neurology, Dept of Medicine and Therapeutics,PWH,The Chinese University of Hong Kong

Medicine & Therapeutics, The Chinese University of Hong Kong

NA

Not Applicable

Roxanna LIU

Division of Neurology, Dept of Medicine and Therapeutics,PWH

2632 3877

roxannaliu@cuhk.edu.hk

Division of Neurology, Dept of Medicine and Therapeutics, PWH, CUHK

Hong Kong

Ka Sing WONG

Division of Neurology, Dept of Medicine and Therapeutics,PWH

2632 3877

ks-wong@cuhk.edu.hk

Dept of Medicine and Therapeutics, PWH, CUHK

Hong Kong

A randomized controlled trial of transcranial magnetic stimulation andenhanced external counter pulsation to improve hand function afterischemic stroke

A randomized controlled trial of transcranial magnetic stimulation andenhanced external counter pulsation to improve hand function afterischemic stroke

體外反搏與經顱磁刺激聯合療法對中風病人手部運動功能康復的研究

TBS-EECP

HK

Yes

2014-01-07

Joint CUHK-NTEC Clinical Research Ethics Committee

2013.674-T

stroke

Device

transcranial magnetic stimulation & enhanced external conterpulsation

NA

NA

3 min TBS and 60 min EECP

10 sessions for TBS and EECP

10 sessions of sham therapy

NA

NA

3 min TBS and 60 min EECP

10 sessions for TBS and EECP

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.

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 > 300 μmol/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 >180mmHg or diastolic > 100mmHg);
13) subject has thrombocytopenia (platelet count < 100,000/mm3);
14) evidence of arteriovenous malformation, arteriovenous fistula or aneurysm;
15) evidence of diabetic retinopathy.

18

80

Both Male and Female

Interventional

Randomized

prospective

Placebo

Single-blind

Trial subjects

Parallel

0

2014-09-20

80

Recruiting

upper limb Fugl-Meyer Assessment (FMA) at 90 days after intervention

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 at baseline (1 day), 10 days or last session of therapy and 90 days after intervention.

No

2017-04-25

ChiCTR-TRC-14005009 

2014-07-25

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