HealthyNCT03304262
Metaplasticity Experimental Design and Comparison of Motor Outcome Measure Sensitivity to Change
A study testing rTMS in people with Healthy, run by University of New Mexico at 1 site in United States.
Trial summary
The overall objective is to validate the methodology of a metaplasticity experimental design by assessing change in motor excitability after administration of priming transcranial direct current stimulation (tDCS) followed by repetitive transcranial magnetic stimulation (rTMS) in healthy human participants. Read more about this study
- Who is it for?
- Ages 18 to 99 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- rTMS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Jul 2017to 31 Mar 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 99 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Must be at least 18 years of age (all genders, races, ethnicity)
- Must have no current psychiatric or neurologic issues
- Must not have any conditions listed in exclusion criteria
- Must be fluent in English
Who cannot join
- History of major psychiatric illness
- Actively using neuropsychoactive medication
- Legal or mental incompetency
- Substance use disorder, abuse or dependence, with active use within the last three months
- Significant medical or neurological illness
- Prior neurosurgical illness
Show all 11Show fewer
- Prior neurosurgical procedure
- History of seizure
- History of ECT or TMS treatment within the past there months
- Presence of a pacemaker, implanted medical pump or device, metal plate, or metal object in skull or eye (including shunts, dental implants, facial tattoos with metallic ink)
- Pregnant women
Trial locations and contacts
1 site in 1 country.
United States1 site
University of New Mexico
Albuquerque, New Mexico, 87106
About this study
Official title: Metaplasticity in the Human Motor Cortex: Validation of an Experimental Design and Comparison of Motor Outcome Measure Sensitivity to Change
The overall objective is to validate the methodology of a metaplasticity experimental design by assessing change in motor excitability after administration of priming transcranial direct current stimulation (tDCS) followed by repetitive transcranial magnetic stimulation (rTMS) in healthy human participants.
Read the detailed description
The overall objective is to validate the methodology of a metaplasticity experimental design by assessing change in motor excitability after administration of priming transcranial direct current stimulation (tDCS) followed by repetitive transcranial magnetic stimulation (rTMS) in healthy human participants. Our primary objective is to compare pre- and post-measures of cortical excitability before priming tDCS (anodal, cathodal or sham) [M1], directly after priming tDCS [M2], directly after inhibitory rTMS [M3], and 10 minutes after inhibitory rTMS [M4]. Our secondary objective is to evaluate the sensitivity of motor excitability outcome measures response to the noninvasive neurostimulation (e.g. rTMS and tDCS). We also aim to compare pre- and post- measures of cortical excitability after inhibitory and excitatory priming of the motor cortex, and to evaluate the sensitivity of motor outcome measures to changes in cortical plasticity.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rTMSDevice
Also called rapid transcranial magnetic stimulation
Between time point M2 and M3, participant will receive 900 pulses of rTMS at 1Hz at 0.85 of M2 resting motor threshold.
| Study group | Role | What they receive |
|---|---|---|
| Cathodal tDCS + rTMS then Anodal tDCS + rTMS then Sham tDCS + rTMS | Active comparator | Participant will receive 10 minutes of cathodal tDCS between M1 and M2 timepoints, and rTMS for 900 1Hz pulses at 0.85 of Resting Motor Threshold at M2. After 1 week washout, participant will receive 10 minutes of anodal tDCS and rTMS for 900 1Hz pulses at 0.85 RMT. After 1 week washout, participant will receive 10 minutes of sham tDCS and rTMS for 900 1 Hz pulses at 0.85 RMT. Receives: Device: rTMS |
| Anodal tDCS + rTMS then Sham tDCS + rTMS then Cathodal tDCS + rTMS | Active comparator | Participant will receive 10 minutes of anodal tDCS between M1 and M2 timepoints, and rTMS for 900 1Hz pulses at 0.85 of Resting Motor Threshold at M2. After 1 week washout, participant will receive 10 minutes of sham tDCS and rTMS for 900 1 Hz pulses at 0.85 RMT. After 1 week washout, participant will receive 10 minutes of cathodal tDCS and rTMS for 900 1 Hz pulses at 0.85 RMT. Receives: Device: rTMS |
| Sham tDCS + rTMS then Cathodal tDCS + rTMS then Anodal tDCS + rTMS | Sham comparator | Participant will receive 10 minutes of sham tDCS between M1 and M2 timepoints, and rTMS for 900 1Hz pulses at 0.85 of Resting Motor Threshold at M2. After 1 week washout, participant will receive 10 minutes of cathodal tDCS and rTMS for 900 1 Hz pulses at 0.85 RMT. After 1 week washout, participant will receive 10 minutes of anodal tDCS and rTMS for 900 1 Hz pulses at 0.85 RMT. Receives: Device: rTMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change in MEP Amplitude
Percent Change in MEP amplitude over the first dorsal interosseous (FDI) muscle of the right hand
Measured: assessed and reported throughout study completion pre- and post- intervention approximately 30 minutes
Secondary outcomes (2)
Cortical Silent Period
Change in length of CSP
Measured: tDCS + rTMS assessed and reported pre and post (approximately 10 minutes)
Simple Reaction Time
Participants will perform a simple reaction time task. This will be measured in seconds of response after a stimulus. The final outcome will be percent change in the reaction time from pre- to post- intervention.
Measured: The final outcome will be percent change in the reaction time from pre- to post- intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2017
- Study start18 Jul 2017
- Primary completion28 Feb 2018
- Study completion31 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HealthyStudies 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
- Model description
- This is a randomized, sham-controlled, double blinded crossover trial.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of New Mexico
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sarah Pirio Richardson, University of New Mexico
- Investigators
- Sarah Pirio Richardson, M.D., Principal investigator, University of New MexicoDavin Quinn, M.D., Principal investigator, University of New Mexico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03304262
- Sponsor's protocol ID
- 16-410
- Status last verified
- Aug 2023
- First submitted
- 21 Sep 2017
- Last updated
- 25 Aug 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metaplasticity in the Human Motor Cortex: Validation of an Experimental Design and Comparison of Motor Outcome Measure Sensitivity to Change
- ClinicalTrials.gov ID
- NCT03304262
- Acronym / sponsor ID
- 16-410
- Conditions
- Healthy
- Keywords
- Metaplasticity, Motor excitability, rTMS, tDCS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- University of New MexicoUniversity, hospital or other
- Study start
- 18 Jul 2017 (actual)
- Primary completion
- 28 Feb 2018 (actual)
- Study completion
- 31 Mar 2018 (actual)
- First posted
- 6 Oct 2017 (actual)
- Results
- Posted 25 Aug 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The overall objective is to validate the methodology of a metaplasticity experimental design by assessing change in motor excitability after administration of priming transcranial direct current stimulation (tDCS) followed by repetitive transcranial magnetic stimulation (rTMS) in healthy human participants.
Detailed description
The overall objective is to validate the methodology of a metaplasticity experimental design by assessing change in motor excitability after administration of priming transcranial direct current stimulation (tDCS) followed by repetitive transcranial magnetic stimulation (rTMS) in healthy human participants. Our primary objective is to compare pre- and post-measures of cortical excitability before priming tDCS (anodal, cathodal or sham) [M1], directly after priming tDCS [M2], directly after inhibitory rTMS [M3], and 10 minutes after inhibitory rTMS [M4]. Our secondary objective is to evaluate the sensitivity of motor excitability outcome measures response to the noninvasive neurostimulation (e.g. rTMS and tDCS). We also aim to compare pre- and post- measures of cortical excitability after inhibitory and excitatory priming of the motor cortex, and to evaluate the sensitivity of motor outcome measures to changes in cortical plasticity.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- This is a randomized, sham-controlled, double blinded crossover trial.
| Arm | Type | Receives |
|---|---|---|
| Cathodal tDCS + rTMS then Anodal tDCS + rTMS then Sham tDCS + rTMS | Active comparator | Device: rTMSParticipant will receive 10 minutes of cathodal tDCS between M1 and M2 timepoints, and rTMS for 900 1Hz pulses at 0.85 of Resting Motor Threshold at M2. After 1 week washout, participant will receive 10 minutes of anodal tDCS and rTMS for 900 1Hz pulses at 0.85 RMT. After 1 week washout, participant will receive 10 minutes of sham tDCS and rTMS for 900 1 Hz pulses at 0.85 RMT. |
| Anodal tDCS + rTMS then Sham tDCS + rTMS then Cathodal tDCS + rTMS | Active comparator | Device: rTMSParticipant will receive 10 minutes of anodal tDCS between M1 and M2 timepoints, and rTMS for 900 1Hz pulses at 0.85 of Resting Motor Threshold at M2. After 1 week washout, participant will receive 10 minutes of sham tDCS and rTMS for 900 1 Hz pulses at 0.85 RMT. After 1 week washout, participant will receive 10 minutes of cathodal tDCS and rTMS for 900 1 Hz pulses at 0.85 RMT. |
| Sham tDCS + rTMS then Cathodal tDCS + rTMS then Anodal tDCS + rTMS | Sham comparator | Device: rTMSParticipant will receive 10 minutes of sham tDCS between M1 and M2 timepoints, and rTMS for 900 1Hz pulses at 0.85 of Resting Motor Threshold at M2. After 1 week washout, participant will receive 10 minutes of cathodal tDCS and rTMS for 900 1 Hz pulses at 0.85 RMT. After 1 week washout, participant will receive 10 minutes of anodal tDCS and rTMS for 900 1 Hz pulses at 0.85 RMT. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Must be at least 18 years of age (all genders, races, ethnicity)
- Must have no current psychiatric or neurologic issues
- Must not have any conditions listed in exclusion criteria
- Must be fluent in English
Key exclusion criteria (11 listed)
- History of major psychiatric illness
- Actively using neuropsychoactive medication
- Legal or mental incompetency
- Substance use disorder, abuse or dependence, with active use within the last three months
- Significant medical or neurological illness
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 |
|---|---|---|
| rTMSAlso: rapid transcranial magnetic stimulationBetween time point M2 and M3, participant will receive 900 pulses of rTMS at 1Hz at 0.85 of M2 resting motor threshold. | Device | Anodal tDCS + rTMS then Sham tDCS + rTMS then Cathodal tDCS + rTMS, Cathodal tDCS + rTMS then Anodal tDCS + rTMS then Sham tDCS + rTMS, Sham tDCS + rTMS then Cathodal tDCS + rTMS then Anodal tDCS + rTMS |
Primary outcome
Percent Change in MEP Amplitude
Time frame: assessed and reported throughout study completion pre- and post- intervention approximately 30 minutes
Percent Change in MEP amplitude over the first dorsal interosseous (FDI) muscle of the right hand
2 secondary outcomes
Cortical Silent Period
Time frame: tDCS + rTMS assessed and reported pre and post (approximately 10 minutes)
Simple Reaction Time
Time frame: The final outcome will be percent change in the reaction time from pre- to post- intervention.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Sarah Pirio Richardson, M.D. principal investigator
University of New Mexico
Davin Quinn, M.D. principal investigator
University of New Mexico
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing rTMS in people with Healthy, run by University of New Mexico at 1 site in United States.
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 4 inclusion and 11 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 25 Aug 2023. 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 United States. 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. 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?
Yes. Results are posted in the registry (first posted 25 Aug 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percent Change in MEP Amplitude (time frame: assessed and reported throughout study completion pre- and post- intervention approximately 30 minutes). 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 25 Aug 2023.