Centre For Clinical Research And Biostatistics (CCRB)

Back History

1 Unique Trial Number (assigned by CCRB)

CUHK_CCRB00504

2 Trial Registration Date

2016-03-30

iRegistration Status

Prospective

3 Secondary IDs

RGC Ref No.14111115

4 Source(s) of Funding

General Research Fund

5 Primary Sponsor

Research Grant Council

6 Secondary Sponsor

Not applicable

Function

Not Applicable

Please specify

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

i Name

Lu, Hanna

ii Address

G/F, Multi-centre,
Department of Psychiatry
Tai Po Hospital.
Tai Po
New Territories
Hong Kong

iii Phone

28314305

iv Email

hanna19830213@gmail.com

v Affiliation

Department of Psychiatry, The Chinese University of Hong Kong

vi Country

Hong Kong

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

i Name

Linda Chiu Wa LAM

ii Address

G/F, Multi-centre,
Department of Psychiatry
Tai Po Hospital.
Tai Po
New Territories
Hong Kong

iii Phone

85226076027

iv Email

cwlam@cuhk.edu.hk

v Affiliation

Department of Psychiatry, The Chinese University of Hong Kong

vi Country

Hong Kong

9 Official Scientific Title of the Study

Clinical Efficacy of Neuro-navigated repetitive Transcranial Magnetic Stimulation (rTMS) in the management of Depression in Major Neurocognitive Disorders– a single blind randomized control trial

10 Public Title

Neuro-navigated repetitive Transcranial Magnetic Stimulation (rTMS) for depression in dementia

i Public Title in Chinese 研究名稱

定位連環透顱磁力剌激對認知障礙症患者抑鬱徵狀的療效研究

11 Short Title (Optional)

12 Countries of Recruitment

Hong Kong

13Research Ethic Review

i Has the study received appropriate ethics approval?

Yes

ii When is the approval date?

2015-04-27

iii Full Name of IRB/IEC

Joint CUHK-NTEC Clinical Research Ethics Committee

Please specify

iv IRB/IEC approval reference number

2015.127-T

14 Medical Condition Being Studied

Major Neurocognitive Disorders

15Intervention

i Types of intervention

Other

Please specify

repetitive Transcranial Magnetic Stimulation (rTMS)

ii Description/ name of Intervention/article

Repetitive Transcranial Magnetic Stimulation (rTMS) is a safe and non-invasive brain stimulation approved by for the treatment of Major Depressive Disorder not satisfactorily responded to at least one type of antidepressant in the United States. The electromagnetic field leads to changes in neuronal activities by inducing action potentials along the cells. TMS has been used in the treatment of other neurological conditions including aphasia and neurological pain. There has also been some evidence to suggest that TMS, when combined with cognitive training, may exert positive effects on cognition in patients with Alzheimer’s disease (AD).

iii Dosage form of the intervention

Magnetic stimulation

iv Dosage of the intervention

10 Hz, 30 trains and 1500 pulses per day

v Duration of the intervention

3 weeks

vi Frequency of the intervention

5 (once daily) treatment sessions per week

16Comparative Treatments

i Description/ name of comparative treatments

Sham Transcranial Magnetic Stimulation

ii Dosage form of the comparative treatments

Sham magnetic stimulation

iii Dosage of the comparative treatments

Sham magnetic stimulation

iv Duration of the comparative treatments

3 weeks

v Frequency of the comparative treatments

5 (once daily) treatment sessions per week

17Key Inclusion and Exclusion Criteria

i Inclusion Criteria

Major Neurocognitive Disorder due to AD

Major Vascular Neurocognitive Disorder with small vessel disease

Cornell Scale for Depression in dementia (CSDD) with a rating of 7 or over

ii Exclusion Criteria

Past history of bipolar affective disorder or psychosis

Physically frail affecting attendance to TMS sessions

Already attending other brain stimulation therapies

History of major neurological deficit including history of major stroke, transient ischemic attack or traumatic brain injury

Significant communicative impairment

iii Age Minimum

60

iv Age Maximum

90

v Gender

Both Male and Female

18 Study Type

Interventional

19Study Design

i Randomization

Randomized

Please specify

Participants would be individually randomized into either rTMS or sham TMS groups.

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

Other

Please specify

Non-drug intervention

vi Study Objectives (Optional)

20 Anticipated trial start date

2016-04-01

21 Target Sample Size

60

22 Recruitment Status

Not Yet Recruiting

23Primary Outcome

iThe Name of the outcome

Depressive symptoms

iiThe metric or method of measurement used

Cornell Scale for Depression in dementia (CSDD)

iiiThe timepoint(s) of primary interest

Third week; Sixth week; Twelfth week

24Secondary Outcome

iThe Name of the outcome

Global cognitive function

iiThe metric or method of measurement used

Hong Kong Chinese version of Montreal Cognitive Assessment (MoCA)

iiiThe timepoint(s) of primary interest

Third week; Sixth week; Twelfth week

Secondary Outcome

iThe Name of the outcome

Neuropsychiatric symptoms

iiThe metric or method of measurement used

The Chinese Neuropsychiatric Inventory (NPI)

iiiThe timepoint(s) of primary interest

Third week; Sixth week; Twelfth week

Secondary Outcome

iThe Name of the outcome

Quality of life

iiThe metric or method of measurement used

Quality of Life – AD (QOL-AD)

iiiThe timepoint(s) of primary interest

Third week; Sixth week; Twelfth week

Secondary Outcome

iThe Name of the outcome

Serum BDNF levels

iiThe metric or method of measurement used

Brain-derived neurotrophic factor (BDNF)

iiiThe timepoint(s) of primary interest

Third week; Sixth week; Twelfth week

Secondary Outcome

iThe Name of the outcome

Adverse effects

iiThe metric or method of measurement used

A checklist of potential adverse effects associated with rTMS administration

iiiThe timepoint(s) of primary interest

Third week; Sixth week; Twelfth week

25Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26Last Update Date

2016-03-30

27 Primary Registry and Trial Identifying Number

28 Date of Registration in Primary Registry

Back History

Trial Detail