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Mechanisms of Non-Invasive Neuromodulation Interventions: Influence on Human Neurochemistry and Functional Connectivity
NA trial testing Inhibitory rTMS (1 Hz) in Non-invasive Neuromodulation in Healthy Subjects in 8 participants. Completed in 19 March 2017.
| Lead sponsor | University of Minnesota |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | basic science |
| Enrollment | 8 |
| Start date | 29 August 2016 |
| Primary completion | 19 March 2017 |
| Estimated completion | 19 March 2017 |
| Sites | 1 location across United States |
University of Minnesota
Adults 21 to 40, male only, with Non-invasive Neuromodulation in Healthy Subjects. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
GABA concentration is quantified with MRS at 7 Tesla. Percent change of GABA concentration is calculated from baseline (i.e., pre-rTMS).
| Group | Value | 95% CI |
|---|---|---|
| Inhibitory rTMS (1 Hz) | 8 | ± 9 |
| Excitatory rTMS (5 Hz) | -27 | ± NA |
GABA concentration is quantified with MRS at 7 Tesla. Percent change of GABA concentration is calculated from baseline (i.e., pre-rTMS).
| Group | Value | 95% CI |
|---|---|---|
| Inhibitory rTMS (1 Hz) | -6 | ± 6 |
| Excitatory rTMS (5 Hz) | 4 | ± NA |
Functional connectivity is measured with MRI at 7 Tesla as a dimensionless fractional amplitude of low-frequency fluctuations (fALFF). This is an index which reflects the intensity of spontaneous regional brain activity. It is calculated as the ratio of power spectra of low frequency (0.01-0.08 Hz) to that of the entire frequency range. Percent change of functional connectivity is calculated from baseline (i.e., pre-rTMS).
| Group | Value | 95% CI |
|---|---|---|
| Inhibitory rTMS (1 Hz) | -2 | ± 11 |
| Excitatory rTMS (5 Hz) | 9 | ± NA |
Functional connectivity is measured with MRI at 7 Tesla as a dimensionless fractional amplitude of low-frequency fluctuations (fALFF). This is an index which reflects the intensity of spontaneous regional brain activity. It is calculated as the ratio of power spectra of low frequency (0.01-0.08 Hz) to that of the entire frequency range. Percent change of functional connectivity is calculated from baseline (i.e., pre-rTMS).
| Group | Value | 95% CI |
|---|---|---|
| Inhibitory rTMS (1 Hz) | -1 | ± 10 |
| Excitatory rTMS (5 Hz) | 17 | ± NA |
Time frame: approximately 4 hours. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Inhibitory rTMS (1 Hz) | Excitatory rTMS (5 Hz) |
|---|---|---|---|
| Sleepiness | General disorders | — | — |
| Anxiety/Worry/Nervousness | Psychiatric disorders | — | — |
| Warmth | General disorders | — | — |
| Metallic Taste | General disorders | — | — |
| Headache | General disorders | — | — |
| Tooth Pain | General disorders | — | — |
| Shoulder Pain | General disorders | — | — |
Data from ClinicalTrials.gov NCT02677740 adverse events section.
The aim of this project is to increase our understanding of how two different protocols of repetitive transcranial magnetic stimulation (rTMS), inhibitory (1 Hz) and excitatory (5 Hz), applied over the primary motor cortex of the presumed dominant hemisphere, affect functional connectivity and neurochemistry in the brain.
1 peer-reviewed publication reference this trial (live from Europe PMC):
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