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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| rTMS | Device | Between time point M2 and M3, participant will receive 900 pulses of rTMS at 1Hz at 0.85 of M2 resting motor threshold. |
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| Measure | Description | Time Frame |
|---|---|---|
| Percent Change in MEP Amplitude | Percent Change in MEP amplitude over the first dorsal interosseous (FDI) muscle of the right hand | assessed and reported throughout study completion pre- and post- intervention approximately 30 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Cortical Silent Period | Change in length of CSP | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sarah Pirio Richardson, M.D. | University of New Mexico | Principal Investigator |
| Davin Quinn, M.D. | University of New Mexico | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of New Mexico | Albuquerque | New Mexico | 87106 | United States |
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This was a crossover design, in which each participant came in three times and was randomly assigned to each intervention with a wash-out period in between.
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| ID | Title | Description |
|---|---|---|
| FG000 | Cathodal tDCS + rTMS Then Anodal tDCS + rTMS Then Sham tDCS + rTMS | 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 between M1 and M2 timepoints, and rTMS for 900 1 Hz pulses at 0.85 Resting Motor Threshold at M2. After 1 week washout, participant will receive 10 minutes of sham tDCS between M1 and M2 timepoints, and rTMS for 900 1 Hz pulses at 0.85 Resting Motor Threshold at M2. rTMS: Between time point M2 and M3, participant will receive 900 pulses of rTMS at 1Hz at 0.85 of M2 resting motor threshold. |
| FG001 | Anodal tDCS + rTMS Then Sham tDCS + rTMS Then Cathodal tDCS + rTMS | 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 between M1 and M2 timepoints, and rTMS for 900 1 Hz pulses at 0.85 Resting Motor Threshold at M2. After 1 week washout, participant will receive 10 minutes of cathodal tDCS between M1 and M2 timepoints, and rTMS for 900 1 Hz pulses at 0.85 Resting Motor Threshold at M2. rTMS: Between time point M2 and M3, participant will receive 900 pulses of rTMS at 1Hz at 0.85 of M2 resting motor threshold. |
| FG002 | Sham tDCS + rTMS Then Cathodal tDCS + rTMS Then Anodal tDCS + rTMS | 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 between M1 and M2 timepoints, and rTMS for 900 1 Hz pulses at 0.85 Resting Motor Threshold at M2. After 1 week washout, participant will receive 10 minutes of anodal tDCS between M1 and M2 timepoints, and rTMS for 900 1 Hz pulses at 0.85 Resting Motor Threshold at M2. rTMS: Between time point M2 and M3, participant will receive 900 pulses of rTMS at 1Hz at 0.85 of M2 resting motor threshold. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Cathodal tDCS + rTMS Then Anodal tDCS + rTMS Then Sham tDCS + rTMS | 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 between M1 and M2 timepoints, and rTMS for 900 1 Hz pulses at 0.85 Resting Motor Threshold at M2. After 1 week washout, participant will receive 10 minutes of sham tDCS between M1 and M2 timepoints, and rTMS for 900 1 Hz pulses at 0.85 Resting Motor Threshold at M2. rTMS: Between time point M2 and M3, participant will receive 900 pulses of rTMS at 1Hz at 0.85 of M2 resting motor threshold. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percent Change in MEP Amplitude | Percent Change in MEP amplitude over the first dorsal interosseous (FDI) muscle of the right hand | Posted | Mean | Full Range | Percent Change | assessed and reported throughout study completion pre- and post- intervention approximately 30 minutes |
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3 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cathodal tDCS + rTMS | 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. rTMS: Between time point M2 and M3, participant will receive 900 pulses of rTMS at 1Hz at 0.85 of M2 resting motor threshold. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sarah Pirio Richardson | University of New Mexico | 505-272-3342 | spiriorichardson@salud.unm.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 16, 2016 | Jun 20, 2019 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Dec 16, 2016 | Jul 25, 2023 | ICF_001.pdf |
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This is a randomized, sham-controlled, double blinded crossover trial.
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Participants will be blinded to treatment group, investigator administering tDCS will be blinded to which treatment arm subject is assigned to, and the data analyst will be conducting analysis off site and is different than investigator applying stimulation.
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| The final outcome will be percent change in the reaction time from pre- to post- intervention. |
| BG001 | Anodal tDCS + rTMS Then Sham tDCS + rTMS Then Cathodal tDCS + rTMS | 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 between M1 and M2 timepoints, and rTMS for 900 1 Hz pulses at 0.85 Resting Motor Threshold at M2. After 1 week washout, participant will receive 10 minutes of cathodal tDCS between M1 and M2 timepoints, and rTMS for 900 1 Hz pulses at 0.85 Resting Motor Threshold at M2. rTMS: Between time point M2 and M3, participant will receive 900 pulses of rTMS at 1Hz at 0.85 of M2 resting motor threshold. |
| BG002 | Sham tDCS + rTMS Then Cathodal tDCS + rTMS Then Anodal tDCS + rTMS | 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 between M1 and M2 timepoints, and rTMS for 900 1 Hz pulses at 0.85 Resting Motor Threshold at M2. After 1 week washout, participant will receive 10 minutes of anodal tDCS between M1 and M2 timepoints, and rTMS for 900 1 Hz pulses at 0.85 Resting Motor Threshold at M2. rTMS: Between time point M2 and M3, participant will receive 900 pulses of rTMS at 1Hz at 0.85 of M2 resting motor threshold. |
| BG003 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| OG002 | Sham tDCS + rTMS | 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. rTMS: Between time point M2 and M3, participant will receive 900 pulses of rTMS at 1Hz at 0.85 of M2 resting motor threshold. |
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| Secondary | Cortical Silent Period | Change in length of CSP | Posted | Mean | Full Range | Percent change | tDCS + rTMS assessed and reported pre and post (approximately 10 minutes) |
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| Secondary | 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. | Posted | Mean | Full Range | Percent change | The final outcome will be percent change in the reaction time from pre- to post- intervention. |
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| 0 |
| 13 |
| 0 |
| 13 |
| 0 |
| 13 |
| EG001 | Anodal tDCS + rTMS | 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. rTMS: Between time point M2 and M3, participant will receive 900 pulses of rTMS at 1Hz at 0.85 of M2 resting motor threshold. | 0 | 13 | 0 | 13 | 0 | 13 |
| EG002 | Sham tDCS + rTMS | 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. rTMS: Between time point M2 and M3, participant will receive 900 pulses of rTMS at 1Hz at 0.85 of M2 resting motor threshold. | 0 | 13 | 0 | 13 | 0 | 13 |
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