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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/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] 0 0
UNSW10106
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression 0 0
Healthy 0 0
Condition category
Condition code
Mental Health 0 0 0 0
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] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
amplitude of motor evoked potentials
Timepoint [1] 0 0
60 minutes post brain stimulation protocol intervention
Secondary outcome [1] 0 0
motor learning through performance on a 'rotor pursuit task'
Timepoint [1] 0 0
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
Not Applicable
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
16
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Black Dog Institute, University of New South Wales - Sydney,
Recruitment postcode(s) [1] 0 0
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/ct2/show/NCT01317303
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01317303