Comparison of Measures of Plasticity

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Colleen Loo, The University of New South Wales
ClinicalTrials.gov Identifier:
NCT01317303
First received: March 16, 2011
Last updated: October 31, 2013
Last verified: October 2013
  Purpose

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).


Condition Intervention
Depression
Healthy
Procedure: cTBS-PAS25
Procedure: cTBS-iTBS
Procedure: PAS25
Procedure: iTBS

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Comparison of Measures of Plasticity

Resource links provided by NLM:


Further study details as provided by The University of New South Wales:

Primary Outcome Measures:
  • amplitude of motor evoked potentials [ Time Frame: 60 minutes post brain stimulation protocol intervention ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • motor learning through performance on a 'rotor pursuit task' [ Time Frame: time frame relates to 5 blocks of 5 trials for each participant ] [ Designated as safety issue: No ]

Enrollment: 16
Study Start Date: March 2011
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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:
  • Magstim,
  • Digitimer
Experimental: iTBS
190 seconds of intermittent theta-burst stimulation
Procedure: iTBS
190 seconds of intermittent theta-burst stimulation
Other Name: 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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01317303

Locations
Australia, New South Wales
Black Dog Institute, University of New South Wales
Sydney,, New South Wales, Australia, 2031
Sponsors and Collaborators
The University of New South Wales
  More Information

Additional Information:
No publications provided

Responsible Party: Colleen Loo, Professor, The University of New South Wales
ClinicalTrials.gov Identifier: NCT01317303     History of Changes
Other Study ID Numbers: UNSW10106
Study First Received: March 16, 2011
Last Updated: October 31, 2013
Health Authority: Australia: Human Research Ethics Committee

Keywords provided by The University of New South Wales:
paired associative stimulation
theta burst stimulation
transcranial magnetic stimulation
neuroplasticity
healthy controls

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on August 28, 2014