Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCRB00484

2 Trial Registration Date

2015-10-31

i Registration Status

Prospective

3 Secondary IDs

CRE-2015.408

4 Source(s) of Funding

Nil

5 Primary Sponsor

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

6 Secondary Sponsor

NIL

Function

Not Applicable

Please specify

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

i Name

ka Sing Lawrence Wong

ii Address

9/F, Lui Che Woo Clinical Sciences Building
Department of Medicine & Therapeutics
Prince of Wales Hospital
Shatin, NT, Hong Kong

iii Phone

26323144

iv Email

ks-wong@cuhk.edu.hk

v Affiliation

CUHK

vi Country

Hong Kong SAR, China

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

i Name

ka Sing Lawrence Wong

ii Address

9/F, Lui Che Woo Clinical Sciences Building
Department of Medicine & Therapeutics
Prince of Wales Hospital
Shatin, NT, Hong Kong

iii Phone

26323144

iv Email

ks-wong@cuhk.edu.hk

v Affiliation

Division of Neurology, Prince of Wales Hospital

vi Country

Hong Kong SAR, China

9 Official Scientific Title of the Study

A Pilot Study of Dual Hemispheric Theta Burst Stimulation for Chronic Post-Stroke Aphasia

10 Public Title

A Pilot Study of Dual Hemispheric Theta Burst Stimulation for Chronic Post-Stroke Aphasia

i Public Title in Chinese 研究名稱

雙側經顱磁刺激對中風後慢性失語症康復的研究

11 Short Title (Optional)

12 Countries of Recruitment

Hong Kong SAR, China

13 Research Ethic Review

i Has the study received appropriate ethics approval?

Yes

ii When is the approval date?

2015-08-20

iii Full Name of IRB/IEC

Hong Kong East Cluster Research Ethics Committee

Please specify

iv IRB/IEC approval reference number

2015.408

14 Medical Condition Being Studied

aphasia

stroke

15 Intervention

i Types of intervention

Device

Please specify

ii Description/ name of Intervention/article

Transcranial Magnetic Stimulation

iii Dosage form of the intervention

Theta Burst Stimulation

iv Dosage of the intervention

Dual Hemispheric Transcranial Magnetic Stimulation

v Duration of the intervention

about four minutes

vi Frequency of the intervention

once a day, totally ten times

16 Comparative Treatments

i Description/ name of comparative treatments

No comparative treatment
Open label

ii Dosage form of the comparative treatments

NA

iii Dosage of the comparative treatments

NA

iv Duration of the comparative treatments

NA

v Frequency of the comparative treatments

NA

17 Key Inclusion and Exclusion Criteria

i Inclusion Criteria

aged 18 or above, right-handed, Cantonese native speaker

first-ever stroke (both ischemic stroke and hemorrhagic stroke) with onset time more than six months and left middle cerebral artery (LMCA) territory involved;

recordable motor evoked potential (MEP) in either hand

mild to moderate motor-dominant aphasia (National Institution of Health Stroke Scale (NIHSS) Part 9 = 1)

capable of undergoing language assessment (NIHSS Part 1a=0, 1b=0 or 1 and 1c= 0 or 1)

the patient or his/her legally acceptable representative is willing to provide written informed consent

ii Exclusion Criteria

personal history of epilepsy

metallic implants in any part of body

implanted cardiac pacemaker, defibrillator, medication pump or any other implanted electronics

severe skull fracture, serious head injury, history of brain or spinal cord surgery

brain tumor on CT/MRI

administration of drugs that potentially lower seizure threshold

active malignancy

severe co-existing systemic diseases, severe dementia or psychosis

inability to be followed up at regular interval

pregnancy or breast-feeding

pure word deafness

diagnosed dementia

clinical evidence of depression

clinical sign of hearing or visual impairment without aids

alcohol abuse and drug addiction

iii Age Minimum

18

iv Age Maximum

/

v Gender

Both Male and Female

18 Study Type

Interventional

19 Study Design

i Randomization

Non-randomized

Please specify

ii Nature of control

Uncontrolled

iii Degree of masking

Open label

If Single-blind, who will be masked?

iv Group Assignment

Single group

v Study Phase

Other

Please specify

Not a drug trail

vi Study Objectives (Optional)

20 Anticipated trial start date

2015-11-09

21 Target Sample Size

10

22 Recruitment Status

Not Yet Recruiting

23 Primary Outcome

i The Name of the outcome

changes in scores of language assessment

ii The metric or method of measurement used

Cantonese version of Western Aphasia Battery

iii The timepoint(s) of primary interest

right after the intervention finished and two months later

24 Secondary Outcome

i The Name of the outcome

changes in subscores of language assessment

ii The metric or method of measurement used

Cantonese version of Western Aphasia Battery

iii The timepoint(s) of primary interest

right after the intervention finished and two months later

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-IPC-15007337

28 Date of Registration in Primary Registry

2015-10-31

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Trial History Detail on 2016-04-05