Comparison of Measures of Plasticity

Healthy Clinical Trial

Official title:

Comparison of Measures of Plasticity

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01317303
• Other study ID #: UNSW10106
• Status: Completed
• Phase: N/A
• First received: March 16, 2011
• Last updated: October 31, 2013
• Start date: March 2011
• Est. completion date: November 2012

Study information

• Verified date: October 2013
• Source: The University of New South Wales
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Human Research Ethics Committee
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Depression
• Healthy

Intervention

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
• cTBS-iTBS
40 seconds of continuous Theta-burst stimulation, followed by 190 seconds of intermittent Theta-burst stimulation
• PAS25
PAS25 refers to the intervention 'paired-associative stimulation' with peripheral ulnar nerve stimulation followed by TMS to the motor cortex 25 ms after.
• iTBS
190 seconds of intermittent theta-burst stimulation

Locations

Country	Name	City	State
Australia	Black Dog Institute, University of New South Wales	Sydney,	New South Wales

Sponsors (1)

Lead Sponsor	Collaborator
The University of New South Wales

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	amplitude of motor evoked potentials		60 minutes post brain stimulation protocol intervention	No
Secondary	motor learning through performance on a 'rotor pursuit task'		time frame relates to 5 blocks of 5 trials for each participant	No

External Links

•   Black Dog Institute website