ANZCTR - Registration

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

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Trial registered on ANZCTR

Registration number

ACTRN12615000720516

Ethics application status

Approved

Date submitted

29/06/2015

Date registered

13/07/2015

Date last updated

27/05/2016

Type of registration

Retrospectively registered

Titles & IDs

Public title

Non-Invasive Brain Stimulation: the Influence of Gender and Menstrual Phase

Scientific title

An Investigation of the Impact of Gender and the Menstrual Cycle on the Effects of tDCS and rTMS on Cortical Excitability in Healthy Controls.

Secondary ID [1]

Nil

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Healthy human volunteers

Condition category

Condition code

Mental Health

Studies of normal psychology, cognitive function and behaviour

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Participants will either take part in the transcranial direct current stimulation (tDCS) or repetitive transcranial magnetic stimulation (rTMS) rTMS arms of the study. They will not be required to engage in both.

tDCS study arm: 1 mA tDCS. The anodal stimulation will be applied to the left dorsolateral prefrontal cortex and the cathode over the right orbit. Stimulation will be delivered for for 15 minutes using a neuroConn GBH/Eldith DC stimulator.

rTMS study arm: Fifty trains of 10 Hz rTMS delivered at 120% of resting motor threshold. rTMS will be delivered using the MagPro R30 to the left DLPFC. Trains will be 4.5 second in duration with a 20.5 second inter-train interval (2250 pulses over 20.8 minutes).

Males will take part in one testing session only. Females will take part in two testing sessions: once during an early phase of the menstrual cycle when endogenous estrogen is low, and once more during a later phase when endogenous estrogen level are high.

Intervention code [1]

Treatment: Devices

Comparator / control treatment

The study is a comparison of cortical excitability between male and female adults, and within the female cohort of high and low estrogen phases of the menstrual cycle.

Changes in cortical excitability will be compared within the TMS and tDCS arms of the study, but not between the two techniques.

Control group

Uncontrolled

Outcomes

Primary outcome [1]

For both arms of the study, the amplitude of pre vs post stimulation cortical evoked potentials measured from the DLPFC.

Single pulse TMS/EEG will be used to measure cortical evoked potentials.

Timepoint [1]

Cortical evoked potential amplitude 20-minutes following stimulation, relative to pre-stimulation.

Secondary outcome [1]

For both arms of the study, the amplitude of pre vs post stimulation cortical evoked potentials measured from the DLPFC.

Single pulse TMS/EEG will be used to measure cortical evoked potentials.

Timepoint [1]

Cortical evoked potential amplitude immediately following stimulation, relative to pre-stimulation.

Eligibility

Key inclusion criteria

1. Are voluntary and competent to consent,
2. Are right handed ,
3. Have no history of endocrine disorder, traumatic brain injury or neurological or mental illness.

Minimum age

18 Years

Maximum age

40 Years

Sex

Both males and females

Can healthy volunteers participate?

Yes

Key exclusion criteria

General Exclusion Criteria:

1. Are a professional driver,
2. Have epilepsy or a history of seizure,
3. Currently taking any psychoactive medications,
4. Have metal anywhere in the head, except the mouth. This includes metallic objects such as screws and slips from surgical procedures.

Female Specific Exclusion Criteria

1. Are currently pregnant or lactating,
2. Currently taking the oral contraceptive pill,
3. Have an irregular menstrual cycle.

Study design

Purpose of the study

Treatment

Allocation to intervention

Non-randomised trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Masking / blinding

Who is / are masked / blinded?

Intervention assignment

Other design features

Phase

Not Applicable

Type of endpoint/s

Statistical methods / analysis

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

1/04/2015

Actual

1/04/2015

Date of last participant enrolment

Anticipated

Actual

3/03/2016

Date of last data collection

Anticipated

Actual

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

VIC

Funding & Sponsors

Funding source category [1]

University

Name [1]

Monash University

Address [1]

Wellington Rd
Clayton, VIC
3168

Country [1]

Australia

Primary sponsor type

University

Name

Monash University

Address

Wellington Rd
Clayton, VIC
3168

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Alfred Health Human Ethics Committee

Ethics committee address [1]

Alfred Health Human Ethics Committee
Alfred Hospital
Commercial Rd
Prahran
3181 VIC

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

26/05/2014

Ethics approval number [1]

129/14

Summary

Brief summary

Non-invasive brain stimulation is emerging as a therapeutic tool for many brain related conditions. There are numerous non-invasive brain stimulation techniques that apply electrical or electromagnetic stimulation to the brain in different ways to alter neural activity. The most researched, and consequently best developed, of these are transcranial magnetic stimulation (TMS) and transcranial direct current stimulation (tDCS). Both TMS and tDCS has been shown to have varying degrees of therapeutic efficacy for major depression. Research efforts are currently focused on identifying factors that modulate individual differences in the way the brain response to TMS which could lead to development of optimised protocols for stimulation delivery.

There is evidence that sex hormones may modulate the effect of TMS and tDCS. However very few studies have investigated this and none have focused on the dorsolateral prefrontal cortex, the site that both methods are most often applied in a clinical context. The current project is an investigation of the impact of gender, and within female gender of menstrual phases associated with high and low estrogen, on the effect of TMS and tDCS to the dorsolateral prefrontal cortex.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Rebecca Segrave

Address

Monash Alfred Psychiatry Research Centre Level 4, 607 St Kilda Rd Prahran VIC 3181

Country

Australia

Phone

+61 3 9076 5030

Fax

rebecca.segrave@monash.edu

Contact person for public queries

Name

Cassandra Thomson

Address

Monash Alfred Psychiatry Research Centre Level 4, 607 St Kilda Rd Prahran VIC 3181

Country

Australia

Phone

+61 3 9076 6592

Fax

cassandra.thomson@monash.edu

Contact person for scientific queries

Name

Rebecca Segrave

Address

Monash Alfred Psychiatry Research Centre Level 4, 607 St Kilda Rd Prahran VIC 3181

Country

Australia

Phone

+61 3 9076 5030

Fax

rebecca.segrave@monash.edu

No information has been provided regarding IPD availability

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

Source	Title	Year of Publication	DOI
Embase	The influence of endogenous estrogen on transcranial direct current stimulation: A preliminary study.	2018	https://dx.doi.org/10.1111/ejn.14085

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added manually

Documents added automatically