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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01317303

Registration number

NCT01317303

Ethics application status

Date submitted

16/03/2011

Date registered

17/03/2011

Date last updated

3/11/2013

Titles & IDs

Public title

Comparison of Measures of Plasticity

Scientific title

Comparison of Measures of Plasticity

Secondary ID [1]

UNSW10106

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

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

Depression

Healthy

Condition category

Condition code

Mental Health

Depression

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Treatment: Surgery - cTBS-PAS25
Treatment: Surgery - cTBS-iTBS
Treatment: Surgery - PAS25
Treatment: Surgery - iTBS

Experimental: PAS25 - PAS25 refers to the intervention 'paired-associative stimulation' with peripheral ulnar nerve stimulation followed by TMS to the motor cortex 25 ms after.

Experimental: cTBS-PAS - 40 seconds of continuous Theta-burst stimulation, followed by PAS25 which refers to the intervention 'paired-associative stimulation' with peripheral ulnar nerve stimulation followed by TMS to the motor cortex 25 ms after.

Experimental: iTBS - 190 seconds of intermittent theta-burst stimulation

Experimental: cTBS-iTBS - 40 seconds of continuous Theta-burst stimulation, followed by 190 seconds of intermittent Theta-burst stimulation

Treatment: Surgery: cTBS-PAS25
40 seconds of continuous Theta-burst stimulation, followed by PAS25 which refers to the intervention 'paired-associative stimulation' with peripheral ulnar nerve stimulation followed by TMS to the motor cortex 25 ms after

Treatment: Surgery: cTBS-iTBS
40 seconds of continuous Theta-burst stimulation, followed by 190 seconds of intermittent Theta-burst stimulation

Treatment: Surgery: PAS25
PAS25 refers to the intervention 'paired-associative stimulation' with peripheral ulnar nerve stimulation followed by TMS to the motor cortex 25 ms after.

Treatment: Surgery: iTBS
190 seconds of intermittent theta-burst stimulation

Intervention code [1]

Treatment: Surgery

Comparator / control treatment

Control group

Outcomes

Primary outcome [1]

amplitude of motor evoked potentials

Timepoint [1]

60 minutes post brain stimulation protocol intervention

Secondary outcome [1]

motor learning through performance on a 'rotor pursuit task'

Timepoint [1]

time frame relates to 5 blocks of 5 trials for each participant

Eligibility

Key inclusion criteria

* healthy controls
* those suffering depression
* aged

Minimum age

18 Years

Maximum age

75 Years

Sex

Both males and females

Can healthy volunteers participate?

Yes

Key exclusion criteria

1. Significant Neurological illness, including epilepsy
2. Alcohol use above NHRMC guidelines
3. Illicit drug use
4. Electronic implant; such as cochlear implant or pacemaker
5. Musculoskeletal disorder

Study design

Purpose of the study

Diagnosis

Allocation to intervention

Randomised controlled 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

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Crossover

Other design features

Phase

Type of endpoint/s

Statistical methods / analysis

Recruitment

Recruitment status

Completed

Data analysis

Reason for early stopping/withdrawal

Other reasons

Date of first participant enrolment

Anticipated

Actual

1/03/2011

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

Actual

1/11/2012

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

NSW

Recruitment hospital [1]

Black Dog Institute, University of New South Wales - Sydney,

Recruitment postcode(s) [1]

2031 - Sydney,

Funding & Sponsors

Primary sponsor type

Other

Name

The University of New South Wales

Address

Country

Ethics approval

Ethics application status

Summary

Brief summary

Neuroplasticity refers to the ability of the nerve cells to modify their structure or function in response to injury or insult, or other environmental stimuli, with these changes outlasting the period of exposure. Plasticity may be observed as short term or long term changes. In humans, neuroplasticity can be readily assessed in the motor cortex, as excitability changes are demonstrated in the degree to which peripheral muscles are activated, seen through changes in motor-evoked potentials (MEPs). In this study, a number of approaches to assessing neuroplasticity will be evaluated: Paired-associative stimulation (PAS), Theta Burst Stimulation (TBS), which is a form of transcranial magnetic stimulation (TMS) and protocols that combine these two. In addition, participants will complete a computerised 'rotor pursuit task' designed to provide a measure of motor learning.

The investigators aim to find the most efficacious (defined by greatest number of responders and effect size as seen in an increase in MEP amplitude) brain stimulation protocol. The investigators will expose the same participants to four excitatory conditioning stimulation paradigms, with each session separated by at least a week.

Our hypotheses include:

The four conditioning stimulation protocols should increase motor cortical excitability, the investigators therefore expect there to be a significant increase in participant MEPs, with a positive correlation in the increase ofMEP amplitude of the protocols. The investigators do however expect that due to the principles of homeostatic metaplasticity, that the protocols preceded by cTBS will show greater MEP change, due to the lowering of the threshold for LTP plasticity induction. In addition, the investigators expect that an increase in the motor learning manifest by the rotor pursuit task and for there to be a correlation in participants between the increase in MEP amplitude and the improvement in time on target (TOT) shown in the motor learning task (MLT).

Trial website

https://clinicaltrials.gov/study/NCT01317303

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Address

Country

Phone

Fax

Contact person for public queries

Name

Address

Country

Phone

Fax

Contact person for scientific queries

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

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT01317303

Trial Review

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01317303