DepressionNCT01317303
Comparison of Measures of Plasticity
A study testing cTBS-PAS25, cTBS-iTBS and PAS25 in people with Depression and Healthy, run by The University of New South Wales at 1 site in Australia.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Depression, Healthy
- What is being tested?
- cTBS-PAS25, cTBS-iTBS and PAS25
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteAustralia
- Study dates
- Mar 2011to Nov 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- healthy controls
- those suffering depression
- aged
Who cannot join
- Significant Neurological illness, including epilepsy
- Alcohol use above NHRMC guidelines
- Illicit drug use
- Electronic implant; such as cochlear implant or pacemaker
- Musculoskeletal disorder
Trial locations and contacts
1 site in 1 country.
Australia1 site
Black Dog Institute, University of New South Wales
Sydney, New South Wales, 2031
About this study
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.
Read more
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).
- Conditions
- Depression, Healthy
- Being tested
- cTBS-PAS25, cTBS-iTBS, PAS25, iTBS
- Keywords
- paired associative stimulation, theta burst stimulation, transcranial magnetic stimulation, neuroplasticity, healthy controls
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cTBS-PAS25Procedure or surgery
Also called Magstim,, Digitimer
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-iTBSProcedure or surgery
40 seconds of continuous Theta-burst stimulation, followed by 190 seconds of intermittent Theta-burst stimulation
PAS25Procedure or surgery
Also called Magstim, Digitimer
PAS25 refers to the intervention 'paired-associative stimulation' with peripheral ulnar nerve stimulation followed by TMS to the motor cortex 25 ms after.
iTBSProcedure or surgery
Also called Magstim
190 seconds of intermittent theta-burst stimulation
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: cTBS-PAS25 |
| iTBS | Experimental | 190 seconds of intermittent theta-burst stimulation Receives: Procedure: iTBS |
| cTBS-iTBS | Experimental | 40 seconds of continuous Theta-burst stimulation, followed by 190 seconds of intermittent Theta-burst stimulation Receives: Procedure: cTBS-iTBS |
What is being measured
The primary outcome is the main question the study is designed to answer.
amplitude of motor evoked potentials
Measured: 60 minutes post brain stimulation protocol intervention
Secondary outcomes (1)
motor learning through performance on a 'rotor pursuit task'
Measured: time frame relates to 5 blocks of 5 trials for each participant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2011 (estimated)
- Study startMar 2011
- Primary completionNov 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of New South Wales
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Colleen Loo, The University of New South Wales
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01317303
- Sponsor's protocol ID
- UNSW10106
- Status last verified
- Oct 2013
- First submitted
- 16 Mar 2011
- Last updated
- 4 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Measures of Plasticity
- ClinicalTrials.gov ID
- NCT01317303
- Acronym / sponsor ID
- UNSW10106
- Conditions
- Depression, Healthy
- Keywords
- paired associative stimulation, theta burst stimulation, transcranial magnetic stimulation, neuroplasticity, healthy controls
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- The University of New South WalesUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 17 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| PAS25 | Experimental | Procedure: PAS25PAS25 refers to the intervention 'paired-associative stimulation' with peripheral ulnar nerve stimulation followed by TMS to the motor cortex 25 ms after. |
| cTBS-PAS | Experimental | Procedure: cTBS-PAS2540 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. |
| iTBS | Experimental | Procedure: iTBS190 seconds of intermittent theta-burst stimulation |
| cTBS-iTBS | Experimental | Procedure: cTBS-iTBS40 seconds of continuous Theta-burst stimulation, followed by 190 seconds of intermittent Theta-burst stimulation |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- healthy controls
- those suffering depression
- aged
Key exclusion criteria (5 listed)
- Significant Neurological illness, including epilepsy
- Alcohol use above NHRMC guidelines
- Illicit drug use
- Electronic implant; such as cochlear implant or pacemaker
- Musculoskeletal disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cTBS-PAS25Also: Magstim,, Digitimer40 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 or surgery | cTBS-PAS |
| cTBS-iTBS40 seconds of continuous Theta-burst stimulation, followed by 190 seconds of intermittent Theta-burst stimulation | Procedure or surgery | cTBS-iTBS |
| PAS25Also: Magstim, DigitimerPAS25 refers to the intervention 'paired-associative stimulation' with peripheral ulnar nerve stimulation followed by TMS to the motor cortex 25 ms after. | Procedure or surgery | PAS25 |
| iTBSAlso: Magstim190 seconds of intermittent theta-burst stimulation | Procedure or surgery | iTBS |
Primary outcome
amplitude of motor evoked potentials
Time frame: 60 minutes post brain stimulation protocol intervention
1 secondary outcome
motor learning through performance on a 'rotor pursuit task'
Time frame: time frame relates to 5 blocks of 5 trials for each participant
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2013.
- Black Dog Institute websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cTBS-PAS25, cTBS-iTBS and PAS25 in people with Depression and Healthy, run by The University of New South Wales at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
amplitude of motor evoked potentials (time frame: 60 minutes post brain stimulation protocol intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2013.