Comparison of Measures of Plasticity

October 31, 2013 updated by: Colleen Loo, The University of New South Wales

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Sydney,, New South Wales, Australia, 2031
        • Black Dog Institute, University of New South Wales

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • healthy controls
  • those suffering depression
  • aged

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Procedure: PAS25
PAS25 refers to the intervention 'paired-associative stimulation' with peripheral ulnar nerve stimulation followed by TMS to the motor cortex 25 ms after.
Other Names:
  • Magstim
  • Digitimer
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.
Procedure: 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
Other Names:
  • Digitimer
  • Magstim,
Experimental: iTBS
190 seconds of intermittent theta-burst stimulation
Procedure: iTBS
190 seconds of intermittent theta-burst stimulation
Other Names:
  • Magstim
Experimental: cTBS-iTBS
40 seconds of continuous Theta-burst stimulation, followed by 190 seconds of intermittent Theta-burst stimulation
Procedure: cTBS-iTBS
40 seconds of continuous Theta-burst stimulation, followed by 190 seconds of intermittent Theta-burst stimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
amplitude of motor evoked potentials
Time Frame: 60 minutes post brain stimulation protocol intervention
60 minutes post brain stimulation protocol intervention

Secondary Outcome Measures

Outcome Measure
Time Frame
motor learning through performance on a 'rotor pursuit task'
Time Frame: time frame relates to 5 blocks of 5 trials for each participant
time frame relates to 5 blocks of 5 trials for each participant

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of New South Wales

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2011

Primary Completion (Actual)

November 1, 2012

Study Completion (Actual)

November 1, 2012

Study Registration Dates

First Submitted

March 16, 2011

First Submitted That Met QC Criteria

March 16, 2011

First Posted (Estimate)

March 17, 2011

Study Record Updates

Last Update Posted (Estimate)

November 3, 2013

Last Update Submitted That Met QC Criteria

October 31, 2013

Last Verified

October 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UNSW10106

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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