Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001303134
Ethics application status
Approved
Date submitted
2/09/2019
Date registered
23/09/2019
Date last updated
28/10/2020
Date data sharing statement initially provided
23/09/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Does brain stimulation improve post-stroke depression?
Scientific title
Does high frequency repetitive transcranial magnetic stimulation improve symptoms of depression after stroke
Secondary ID [1] 299301 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stroke
 307170 0
Depression 314429 0
Condition category
Condition code
Stroke 306283 306283 0 0
Ischaemic
Stroke 312773 312773 0 0
Haemorrhagic
Mental Health 312774 312774 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be randomised to one of two study arms. The two arms will be high frequency rTMS to the dorsolateral prefrontal cortex (10 sessions over two weeks, week days only) or sham rTMS.

Stimulation will be delivered at 110% resting motor threshold, 10Hz, 3000 pulses once per day (approx 30 minutes). Ten sessions (over 2 weeks) will be delivered. The intervention will be delivered by a trained and experienced researcher in a university clinical trials facility.
Intervention code [1] 300716 0
Rehabilitation
Comparator / control treatment
Placebo : Sham rTMS will be provided using a sham stimulation coil. Duration, stimulation target and number of sessions will be indentical between real and sham rTMS groups
Control group
Placebo

Outcomes
Primary outcome [1] 305287 0
Change in Beck Depression Inventory score
Timepoint [1] 305287 0
Baseline, Immediately Post-treatment (primary timepoint) and 1 month follow-up
Primary outcome [2] 305288 0
Change in PHQ-9 score
Timepoint [2] 305288 0
Baseline, Immediately Post-treatment (primary timepoint) and 1 month follow-up
Secondary outcome [1] 344735 0
Change in stroke specific self efficacy score (item 1-13)
Timepoint [1] 344735 0
Baseline, Immediately Post-treatment and 1 month follow-up
Secondary outcome [2] 344736 0
Adverse events assessed immediately post treatment using a rTMS specific adverse events form that has been adapted from Brunoni et al. 2011 ( International Journal of Neuropsychopharmacology) And Gillick et al 2015 (Archives of Physical Medicine and Rehabilitation). Examples of possible adverse events can be found in the stated refereces and may include headache, scalp pain, fatigue
Timepoint [2] 344736 0
Immediately Post treatment
Secondary outcome [3] 374419 0
Resting state EEG functional connectivity
Timepoint [3] 374419 0
Baseline, Immediately Post treatment
Secondary outcome [4] 374690 0
Resting state EEG power
Timepoint [4] 374690 0
Baseline, Immediately post treatment

Eligibility
Key inclusion criteria
Stroke (ischemic or hemorrhagic)
Mild to severe depression as measured by the PHQ-9 score (5-27)
No contraindications for rTMS
no change in antidepressant medication for 6 months prior to treatment
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Unsafe for TMS

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
We will use a central randomisation process. Experimental allocation will be randomised between participants by an external researcher not involved in participant recruitment, neurophysiological or behavioral outcome assessment.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomised was performed using a computerised sequence generation with an allocation of 1:1 for active:sham
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/05/2019
Date of last participant enrolment
Anticipated
Actual
2/12/2019
Date of last data collection
Anticipated
Actual
24/01/2020
Sample size
Target
15
Accrual to date
Final
11
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 299053 0
University
Name [1] 299053 0
University of South Australia (UNISA)
Country [1] 299053 0
Australia
Primary sponsor type
University
Name
University of South Australia
Address
108 North Terrace, Adelaide SA 5001 Australia
Country
Australia
Secondary sponsor category [1] 298288 0
Charities/Societies/Foundations
Name [1] 298288 0
Guide Dogs SA
Address [1] 298288 0
251 Morphett St
Adelaide SA 5000
Country [1] 298288 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299987 0
The University of South Australia Human Research Ethics Committee
Ethics committee address [1] 299987 0
108 North Terrace Adelaide, SA 5001 Australia
Ethics committee country [1] 299987 0
Australia
Date submitted for ethics approval [1] 299987 0
Approval date [1] 299987 0
01/03/2018
Ethics approval number [1] 299987 0

Summary
Brief summary
Depression is a common and serious complication after stroke with extensive implications for mental health, functional recovery and health service utilisation (Hackett and Pickles, 2014). Pharmacological therapy has no clear effect on prevention or treatment of post-stroke depression (Hackett et al., 2008), suggesting alternative approaches are required. One novel intervention generating interest is non-invasive brain stimulation (NIBS), with studies reporting some beneficial effects of stimulating hypoactive frontal brain regions; the dorsolateral prefrontal cortex (DLPFC) (Shiozawa et al., 2014). However, few studies have been conducted in people with post-stroke depression so we do not know if this is a viable therapy.

We primarily aim to investigate whether NIBS improves post-stroke depression in a pilot RCT
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 82174 0
Dr Brenton Hordacre
Address 82174 0
University of South Australia, City East Campus, Centenary Building, Level 7, 108 North Terrace Adelaide. 5001 SA, Australia
Country 82174 0
Australia
Phone 82174 0
+61883021286
Fax 82174 0
Email 82174 0
[email protected]
Contact person for public queries
Name 82175 0
Brenton Hordacre
Address 82175 0
University of South Australia, City East Campus, Centenary Building, Level 7, 108 North Terrace Adelaide. 5001, SA Australia
Country 82175 0
Australia
Phone 82175 0
+61883021286
Fax 82175 0
Email 82175 0
[email protected]
Contact person for scientific queries
Name 82176 0
Brenton Hordacre
Address 82176 0
University of South Australia, City East Campus, Centenary Building, Level 7, 108 North Terrace Adelaide. 5001 SA Australia
Country 82176 0
Australia
Phone 82176 0
+61883021286
Fax 82176 0
Email 82176 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Sensitive data


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseThe unusual case of dental pain with sham repetitive transcranial magnetic stimulation: A benign idiosyncrasy or diagnostic opportunity?.2020https://dx.doi.org/10.1016/j.brs.2019.12.003
EmbaseRepetitive transcranial magnetic stimulation for post-stroke depression: a randomised trial with neurophysiological insight.2021https://dx.doi.org/10.1007/s00415-020-10315-6
N.B. These documents automatically identified may not have been verified by the study sponsor.