NCT01317303

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 Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for not_applicable depression

Timeline
Completed

Started Mar 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2011

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

March 16, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 17, 2011

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2012

Completed
Last Updated

November 4, 2013

Status Verified

October 1, 2013

Enrollment Period

1.7 years

First QC Date

March 16, 2011

Last Update Submit

October 31, 2013

Conditions

Keywords

paired associative stimulationtheta burst stimulationtranscranial magnetic stimulationneuroplasticityhealthy controls

Outcome Measures

Primary Outcomes (1)

  • amplitude of motor evoked potentials

    60 minutes post brain stimulation protocol intervention

Secondary Outcomes (1)

  • motor learning through performance on a 'rotor pursuit task'

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

Study Arms (4)

PAS25

EXPERIMENTAL

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

cTBS-PAS

EXPERIMENTAL

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

iTBS

EXPERIMENTAL

190 seconds of intermittent theta-burst stimulation

Procedure: iTBS

cTBS-iTBS

EXPERIMENTAL

40 seconds of continuous Theta-burst stimulation, followed by 190 seconds of intermittent Theta-burst stimulation

Procedure: cTBS-iTBS

Interventions

cTBS-PAS25PROCEDURE

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

Also known as: Magstim,, Digitimer
cTBS-PAS
cTBS-iTBSPROCEDURE

40 seconds of continuous Theta-burst stimulation, followed by 190 seconds of intermittent Theta-burst stimulation

cTBS-iTBS
PAS25PROCEDURE

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

Also known as: Magstim, Digitimer
PAS25
iTBSPROCEDURE

190 seconds of intermittent theta-burst stimulation

Also known as: Magstim
iTBS

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • healthy controls
  • those suffering depression
  • aged

You may not qualify if:

  • Significant Neurological illness, including epilepsy
  • Alcohol use above NHRMC guidelines
  • Illicit drug use
  • Electronic implant; such as cochlear implant or pacemaker
  • Musculoskeletal disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Black Dog Institute, University of New South Wales

Sydney, New South Wales, 2031, Australia

Location

Related Links

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 16, 2011

First Posted

March 17, 2011

Study Start

March 1, 2011

Primary Completion

November 1, 2012

Study Completion

November 1, 2012

Last Updated

November 4, 2013

Record last verified: 2013-10

Locations