Healthy
Conditions
Keywords
Metaplasticity, Motor excitability, rTMS, tDCS
Brief 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.
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.
Interventions
DEVICErTMS
Between time point M2 and M3, participant will receive 900 pulses of rTMS at 1Hz at 0.85 of M2 resting motor threshold.
Sponsors
University of New Mexico
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DIAGNOSTIC
Masking
DOUBLE (Subject, Investigator)
Masking description
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.
Intervention model description
This is a randomized, sham-controlled, double blinded crossover trial.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 99 Years
Healthy volunteers
Yes
Inclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change in MEP Amplitude | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cortical Silent Period | tDCS + rTMS assessed and reported pre and post (approximately 10 minutes) | Change in length of CSP |
| Simple Reaction Time | The final outcome will be percent change in the reaction time from pre- to post- intervention. | 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. |
Countries
United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 4 |
| 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. | 5 |
| 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. | 4 |
| Total | 13 |
Baseline characteristics
| Characteristic | Cathodal tDCS + rTMS Then Anodal tDCS + rTMS Then Sham tDCS + rTMS | Total | Sham tDCS + rTMS Then Cathodal tDCS + rTMS Then Anodal tDCS + rTMS | Anodal tDCS + rTMS Then Sham tDCS + rTMS Then Cathodal tDCS + rTMS |
|---|---|---|---|---|
| Age, Continuous | 35.54 years | 35.54 years | 35.54 years | 35.54 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 8 Participants | 3 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 2 Participants | 5 Participants | 1 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 2 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 3 Participants | 9 Participants | 2 Participants | 4 Participants |
| Region of Enrollment United States | 4 participants | 13 participants | 4 participants | 5 participants |
| Sex: Female, Male Female | 2 Participants | 8 Participants | 2 Participants | 4 Participants |
| Sex: Female, Male Male | 2 Participants | 5 Participants | 2 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 13 | 0 / 13 | 0 / 13 |
| other Total, other adverse events | 0 / 13 | 0 / 13 | 0 / 13 |
| serious Total, serious adverse events | 0 / 13 | 0 / 13 | 0 / 13 |
Outcome results
Primary
Percent Change in MEP Amplitude
Percent Change in MEP amplitude over the first dorsal interosseous (FDI) muscle of the right hand
Time frame: assessed and reported throughout study completion pre- and post- intervention approximately 30 minutes
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Cathodal tDCS + rTMS | Percent Change in MEP Amplitude | 1.19 Percent Change |
| Anodal tDCS + rTMS | Percent Change in MEP Amplitude | 1.06 Percent Change |
| Sham tDCS + rTMS | Percent Change in MEP Amplitude | 1.38 Percent Change |
Secondary
Cortical Silent Period
Change in length of CSP
Time frame: tDCS + rTMS assessed and reported pre and post (approximately 10 minutes)
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Cathodal tDCS + rTMS | Cortical Silent Period | 1.02 Percent change |
| Anodal tDCS + rTMS | Cortical Silent Period | 1.01 Percent change |
| Sham tDCS + rTMS | Cortical Silent Period | 0.99 Percent change |
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.
Time frame: The final outcome will be percent change in the reaction time from pre- to post- intervention.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Cathodal tDCS + rTMS | Simple Reaction Time | 1.01 Percent change |
| Anodal tDCS + rTMS | Simple Reaction Time | 1.02 Percent change |
| Sham tDCS + rTMS | Simple Reaction Time | 1.02 Percent change |