Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00425

2 Trial Registration Date

2014-07-23

i Registration Status

Prospective

3 Secondary IDs

CRE-2013.674-T

4 Source(s) of Funding

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

5 Primary Sponsor

Medicine & Therapeutics, The Chinese University of Hong Kong

6 Secondary Sponsor

NA

Function

Not Applicable

Please specify

7 Responsible Contact Person (public contact person for patients interested in participating)

i Name

Roxanna LIU

ii Address

Division of Neurology, Dept of Medicine and Therapeutics,PWH

iii Phone

2632 3877

iv Email

roxannaliu@cuhk.edu.hk

v Affiliation

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

vi Country

Hong Kong

8 Research Contact Person (person to contact for scientific inquiries)

i Name

Ka Sing WONG

ii Address

Division of Neurology, Dept of Medicine and Therapeutics，PWH

iii Phone

2632 3877

iv Email

ks-wong@cuhk.edu.hk

v Affiliation

Dept of Medicine and Therapeutics, PWH, CUHK

vi Country

Hong Kong

9 Official Scientific Title of the Study

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

10 Public Title

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

i Public Title in Chinese 研究名稱

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

11 Short Title (Optional)

TBS-EECP

12 Countries of Recruitment

HK

13 Research Ethic Review

i Has the study received appropriate ethics approval?

Yes

ii When is the approval date?

2014-01-07

iii Full Name of IRB/IEC

Joint CUHK-NTEC Clinical Research Ethics Committee

Please specify

iv IRB/IEC approval reference number

2013.674-T

14 Medical Condition Being Studied

stroke

15 Intervention

i Types of intervention

Device

Please specify

ii Description/ name of Intervention/article

transcranial magnetic stimulation & enhanced external conterpulsation

iii Dosage form of the intervention

NA

iv Dosage of the intervention

NA

v Duration of the intervention

3 min TBS and 60 min EECP

vi Frequency of the intervention

10 sessions for TBS and EECP

16 Comparative Treatments

i Description/ name of comparative treatments

10 sessions of sham therapy

ii Dosage form of the comparative treatments

NA

iii Dosage of the comparative treatments

NA

iv Duration of the comparative treatments

3 min TBS and 60 min EECP

v Frequency of the comparative treatments

10 sessions for TBS and EECP

17 Key Inclusion and Exclusion Criteria

i 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.

ii 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 > 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.

iii Age Minimum

18

iv Age Maximum

80

v Gender

Both Male and Female

18 Study Type

Interventional

19 Study Design

i Randomization

Randomized

Please specify

prospective

ii Nature of control

Placebo

iii Degree of masking

Single-blind

If Single-blind, who will be masked?

Trial subjects

iv Group Assignment

Parallel

v Study Phase

0

Please specify

vi Study Objectives (Optional)

20 Anticipated trial start date

2014-09-20

21 Target Sample Size

80

22 Recruitment Status

Recruiting

23 Primary Outcome

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

24 Secondary Outcome

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.

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2017-04-25

27 Primary Registry and Trial Identifying Number

ChiCTR-TRC-14005009

28 Date of Registration in Primary Registry

2014-07-25

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Trial History Detail on 2016-08-30