Centre For Clinical Research And Biostatistics (CCRB)

Back History

1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00423

2 Trial Registration Date

2014-07-22

iRegistration Status

Prospective

3 Secondary IDs

CRE-2012.235

4 Source(s) of Funding

Division of Neurology, Department of Medicine & Therapeutics,PWH,CUHK

5 Primary Sponsor

Division of Neurology, Department of Medicine & Therapeutics, The Chinese University of Hong Kong

6 Secondary Sponsor

NA

Function

Not Applicable

Please specify

7Responsible 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 1853

iv Email

roxannaliu@cuhk.edu.hk

v Affiliation

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

vi Country

Hong Kong

8Research 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

Effects of combining External Counterpulsation Therapy and Intermittent Theta Burst Stimulation on Corticomotor Excitability in healthy adults

10 Public Title

Effects of combining External Counterpulsation Therapy and Intermittent Theta Burst Stimulation on Corticomotor Excitability in healthy adults

i Public Title in Chinese 研究名稱

體外反搏及間歇型脈衝磁刺激聯合療法對健康人運動皮質興奮性的研究

11 Short Title (Optional)

NA

12 Countries of Recruitment

HONG KONG, CHINA

13Research Ethic Review

i Has the study received appropriate ethics approval?

Yes

ii When is the approval date?

2012-06-05

iii Full Name of IRB/IEC

Joint CUHK-NTEC Clinical Research Ethics Committee

Please specify

iv IRB/IEC approval reference number

2012.235T

14 Medical Condition Being Studied

Stroke

15Intervention

i Types of intervention

Device

Please specify

ii Description/ name of Intervention/article

transcranial magnetic stimulation

iii Dosage form of the intervention

NA

iv Dosage of the intervention

NA

v Duration of the intervention

30 min ECP and 3 min iTBS

vi Frequency of the intervention

7 sessions daily

16Comparative Treatments

i Description/ name of comparative treatments

sham transcranial magnetic stimulation

ii Dosage form of the comparative treatments

NA

iii Dosage of the comparative treatments

NA

iv Duration of the comparative treatments

30 min ECP and 3 min iTBS

v Frequency of the comparative treatments

7 sessions daily

17Key Inclusion and Exclusion Criteria

i Inclusion Criteria

12 healthy adults aged 18 or more years, with no neurological complaints, and no contraindications to ECP or TMS

ii Exclusion Criteria

1 Personal or family history of epilepsy.
2 Metal implant(s) in any part of body or head (excluding tooth fillings).
3 Implanted cardiac pacemaker, defibrillator, medication pump or any other implanted electronics.
4 Personal history of recurring headaches.
5 History of skull fracture, serious head injury, and any head or brain surgery.
6 History of malignancy.
7 Sustained hypertension (systolic >180mmHg or diastolic > 100mmHg).
8 Subject has thrombocytopenia (platelet count < 100,000/mm3 ).
9 Evidence of arteriovenous malformation, arteriovenous fistula or aneurysm.
10 Subject is unlikely to complete 3 sessions.
11 Subject is a pregnant female or a breast-feeding mother.

iii Age Minimum

18

iv Age Maximum

80

v Gender

Both Male and Female

18 Study Type

Interventional

19Study Design

i Randomization

Not Applicable

Please specify

ii Nature of control

Placebo

iii Degree of masking

Single-blind

If Single-blind, who will be masked?

Trial subjects

iv Group Assignment

Crossover

v Study Phase

0

Please specify

vi Study Objectives (Optional)

20 Anticipated trial start date

2014-07-27

21 Target Sample Size

12

22 Recruitment Status

Complete

23 Primary Outcome

Mean non-conditioned MEP amplitude in non-dominant FDI and ADM at 4 time points (immediately before ECP, immediately after ECP, 5 minutes after iTBS, 20 minutes after iTBS) will be recorded to evaluate the change of cortical excitability.

24 Secondary Outcome

Mean conditioned MEP amplitude in non-dominant FDI and ADM at 4 time points (immediately before ECP, immediately after ECP, 5 minutes after iTBS, 20 minutes after iTBS) will be recorded to evaluate the change of intracortical inhibition .

25Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26Last Update Date

2016-08-30

27 Primary Registry and Trial Identifying Number

ChiCTR-TTRCC-14005007

28 Date of Registration in Primary Registry

2014-07-25

Back History

Trial Detail