HealthyNCT02619643
Primed vs Unprimed Facilitatory and Depressive Paired Associative Stimulation
A study testing Transcranial Magnetic Stimulation (Magstim) in people with Healthy, run by University of Minnesota.
Trial summary
Following brain injury (e.g. stroke), application of non-invasive brain stimulation may improve rehabilitative efforts. However, the most effective method of non-invasive brain stimulation is unknown. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Transcranial Magnetic Stimulation (Magstim)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- No sites listed yet
- Study dates
- Dec 2015to Dec 2017
- 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 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- ≥ 18 and ≤ 30 years of age
- Elicitable motor evoked potential from the motor cortex contralateral to the dominant hand
- Elicitable N20 sensory evoked potential
Who cannot join
- History of neurological disease
- Seizure within the past 2 years
- Currently taking epileptogenic medication
- Peripheral neuropathy
- Cognitive impairment and/or major psychiatric disorder
- Metal in the head (dental permitted)
- Pacemaker or other indwelling devices
- Pregnancy
About this study
Following brain injury (e.g. stroke), application of non-invasive brain stimulation may improve rehabilitative efforts. However, the most effective method of non-invasive brain stimulation is unknown. Paired associative stimulation (PAS) is a method of non-invasive brain stimulation that pairs an electrical peripheral nerve stimulus with a magnetic stimulus to the head. This method can be applied in a manner that increases (facilitates) or decreases (depresses) excitability within the brain. Furthermore, applying two consecutive PAS sessions within minutes of each other (called primed PAS) may augment changes in excitability more than a single PAS session alone.
Thus, the purpose of this study is to compare the effect of a double PAS session (primed PAS) to the effect of a single PAS session (unprimed PAS) and a sham PAS session in healthy individuals.
- Conditions
- Healthy
- Being tested
- Transcranial Magnetic Stimulation (Magstim)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial Magnetic Stimulation (Magstim)Device
Also called TMS, Magstim
| Study group | Role | What they receive |
|---|---|---|
| Primed PAS 1A | Experimental | Two sessions of paired associative stimulation (PAS) using transcranial magnetic stimulation will be applied consecutively (within minutes). Receives: Device: Transcranial Magnetic Stimulation (Magstim) |
| Unprimed PAS 1B | Experimental | A single session of active paired associative stimulation (PAS) using transcranial magnetic stimulation will be applied. Receives: Device: Transcranial Magnetic Stimulation (Magstim) |
| Sham PAS | Sham comparator | A single session of sham paired associative stimulation (PAS) using transcranial magnetic stimulation will be applied Receives: Device: Transcranial Magnetic Stimulation (Magstim) |
| Primed PAS 2A | Experimental | Two sessions of paired associative stimulation (PAS) using transcranial magnetic stimulation will be applied consecutively (within minutes). Receives: Device: Transcranial Magnetic Stimulation (Magstim) |
| Unprimed PAS 2B | Experimental | A single session of active paired associative stimulation (PAS) using transcranial magnetic stimulation will be applied. Receives: Device: Transcranial Magnetic Stimulation (Magstim) |
| Primed PAS 1C | Experimental | Two sessions of paired associative stimulation (PAS) using transcranial magnetic stimulation will be applied consecutively (within minutes). Receives: Device: Transcranial Magnetic Stimulation (Magstim) |
| Primed PAS 2C | Experimental | Two sessions of paired associative stimulation (PAS) using transcranial magnetic stimulation will be applied consecutively (within minutes). Receives: Device: Transcranial Magnetic Stimulation (Magstim) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline peak-to-peak amplitude of motor evoked potential
Single-pulse TMS will be used to evoke a motor response that is recorded using electromyography (EMG). The peak-to-peak amplitude of the EMG response will be measured.
Measured: Immediately before and within 60 minutes following intervention
Change from baseline resting motor threshold
Single-pulse TMS will be used to evoke a motor response that is recorded using electromyography (EMG). The lowest stimulator output needed to elicit a consistent response will be recorded.
Measured: Immediately before and within 60 minutes following intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2015 (estimated)
- Study startDec 2015
- Primary completionDec 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- 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
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kate Frost, MS, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02619643
- Sponsor's protocol ID
- 1601M82561
- Status last verified
- Oct 2019
- First submitted
- 25 Nov 2015
- Last updated
- 1 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Primed vs Unprimed Facilitatory and Depressive Paired Associative Stimulation
- ClinicalTrials.gov ID
- NCT02619643
- Acronym / sponsor ID
- 1601M82561
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- Dec 2015
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 2 Dec 2015 (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.
Following brain injury (e.g. stroke), application of non-invasive brain stimulation may improve rehabilitative efforts. However, the most effective method of non-invasive brain stimulation is unknown. Paired associative stimulation (PAS) is a method of non-invasive brain stimulation that pairs an electrical peripheral nerve stimulus with a magnetic stimulus to the head. This method can be applied in a manner that increases (facilitates) or decreases (depresses) excitability within the brain. Furthermore, applying two consecutive PAS sessions within minutes of each other (called primed PAS) may augment changes in excitability more than a single PAS session alone.
Thus, the purpose of this study is to compare the effect of a double PAS session (primed PAS) to the effect of a single PAS session (unprimed PAS) and a sham PAS session in healthy individuals.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Primed PAS 1A | Experimental | Device: Transcranial Magnetic Stimulation (Magstim)Two sessions of paired associative stimulation (PAS) using transcranial magnetic stimulation will be applied consecutively (within minutes). |
| Unprimed PAS 1B | Experimental | Device: Transcranial Magnetic Stimulation (Magstim)A single session of active paired associative stimulation (PAS) using transcranial magnetic stimulation will be applied. |
| Sham PAS | Sham comparator | Device: Transcranial Magnetic Stimulation (Magstim)A single session of sham paired associative stimulation (PAS) using transcranial magnetic stimulation will be applied |
| Primed PAS 2A | Experimental | Device: Transcranial Magnetic Stimulation (Magstim)Two sessions of paired associative stimulation (PAS) using transcranial magnetic stimulation will be applied consecutively (within minutes). |
| Unprimed PAS 2B | Experimental | Device: Transcranial Magnetic Stimulation (Magstim)A single session of active paired associative stimulation (PAS) using transcranial magnetic stimulation will be applied. |
| Primed PAS 1C | Experimental | Device: Transcranial Magnetic Stimulation (Magstim)Two sessions of paired associative stimulation (PAS) using transcranial magnetic stimulation will be applied consecutively (within minutes). |
| Primed PAS 2C | Experimental | Device: Transcranial Magnetic Stimulation (Magstim)Two sessions of paired associative stimulation (PAS) using transcranial magnetic stimulation will be applied consecutively (within minutes). |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- ≥ 18 and ≤ 30 years of age
- Elicitable motor evoked potential from the motor cortex contralateral to the dominant hand
- Elicitable N20 sensory evoked potential
Key exclusion criteria (8 listed)
- History of neurological disease
- Seizure within the past 2 years
- Currently taking epileptogenic medication
- Peripheral neuropathy
- Cognitive impairment and/or major psychiatric 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 |
|---|---|---|
| Transcranial Magnetic Stimulation (Magstim)Also: TMS, Magstim | Device | Primed PAS 1A, Primed PAS 1C, Primed PAS 2A, Primed PAS 2C, Sham PAS, Unprimed PAS 1B, Unprimed PAS 2B |
Primary outcome
Change from baseline peak-to-peak amplitude of motor evoked potential
Time frame: Immediately before and within 60 minutes following intervention
Single-pulse TMS will be used to evoke a motor response that is recorded using electromyography (EMG). The peak-to-peak amplitude of the EMG response will be measured.
Change from baseline resting motor threshold
Time frame: Immediately before and within 60 minutes following intervention
Single-pulse TMS will be used to evoke a motor response that is recorded using electromyography (EMG). The lowest stimulator output needed to elicit a consistent response will be recorded.
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 1 Nov 2019.
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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.
Kate Frost, MS principal investigator
University of Minnesota
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial Magnetic Stimulation (Magstim) in people with Healthy, run by University of Minnesota.
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 8 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 1 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Change from baseline peak-to-peak amplitude of motor evoked potential (time frame: Immediately before and within 60 minutes following intervention). The study lists 2 primary outcomes in all. 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 1 Nov 2019.