N/A
N=8
Mechanisms of Non-Invasive Neuromodulation Interventions: Influence on Human Neurochemistry and Functional Connectivity
Non-invasive Neuromodulation in Healthy Subjects
Bottom Line
View on ClinicalTrials.gov: NCT02677740 ↗Enrolled (actual)
8
Serious AEs
0.0%
Results posted
Aug 2019
Primary outcome: Primary: Percent Change of GABA Concentration in a Voxel Encompassing the Left Motor Cortex, Measured at 30 Min After rTMS — 8; -27 percent change
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Inhibitory rTMS (1 Hz) (Device); Excitatory rTMS (5 Hz) (Device)
- Age
- Adult · 21+ yrs
- Sex
- Male
- Sponsor
- University of Minnesota
- Primary completion
- Mar 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change of GABA Concentration in a Voxel Encompassing the Left Motor Cortex, Measured at 30 Min After rTMS |
8; -27 | — |
| PRIMARY Percent Change of GABA Concentration in a Voxel Encompassing the Right Motor Cortex, Measured at 60 Min After rTMS |
-6; 4 | — |
| PRIMARY Percent Change of Functional Connectivity in Left Motor Cortex, Where Functional Connectivity is Measured as a Dimensionless Fractional Amplitude of Low-frequency Fluctuations (fALFF), at 80 Min After rTMS |
-2; 9 | — |
| PRIMARY Percent Change of Functional Connectivity in Right Motor Cortex, Where Functional Connectivity is Measured as a Dimensionless Fractional Amplitude of Low-frequency Fluctuations (fALFF), at 80 Min After rTMS |
-1; 17 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
Those volunteers who are evaluated as normal and not met exclusion criteria will be potential candidates for this study.
Exclusion Criteria
The following participants will be excluded from this study, including but not limited to:
- Females
- Left handed males
- Participants who never underwent MRI at 7 Tesla
Participants with:
- any type of bio-implant activated by mechanical, electronic, or magnetic means (e.g. cochlear implants, pacemakers, neurostimulators, bio stimulators, electronic infusion pumps.)
- any type of ferromagnetic bio-implant that could potentially be displaced or damaged, such as aneurysm clips, metallic skull plates, etc.
- non-removable piercing or permanent eyeliner
- retained metal in their body, either from a medical procedure or an injury
Participants who:
- have been diagnosed by a physician as having a psychiatric disorder, substance abuse, neurological and/or cardiovascular disease
- have cardiac or known circulatory impairment, and/or the inability to perspire (poor thermoregulatory function)
- have hyper- or hypotension or arrhythmias
- have known conditions which can lead to emergency medical care
- had a head injury that caused them to lose consciousness for more than 30 minutes or have amnesia for more than 24 hours
- had a brain tumor or stroke
- had one or more seizures, or been given a diagnosis of epilepsy
- have a history of sleep apnea or head trauma that may have caused Traumatic Brain Injury (TBI)
- have a history of anxiety, syncope, panic attacks and/or claustrophobia
- cannot adhere to the experimental protocol for any reason
- started taking chemotherapy or immunomodulatory agents, or had any radiation treatment that could affect the brain
- are currently on any medication
Data sourced from ClinicalTrials.gov (NCT02677740). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.