Healthy Clinical Trial
Official title:
Modeling TMS-induced Cortical Network Activity
This is a study of normal brain physiology in healthy human volunteers. The study aims to understand the physiology of connectivity between brain regions. To reach this aim, it delivers single-pulse transcranial magnetic stimulation (spTMS) to one or two brain areas at a time while electroencephalography (EEG) is measured. When only one brain area is stimulated (uni-focal TMS), the goal is to record how many milliseconds it takes for the activity to spread from the stimulated area to other brain regions (conduction delay). When two brain areas are stimulated (bi-focal TMS), the TMS pulses are separated by a short millisecond-level time interval ("asynchrony") in a so-called paired associative stimulation (PAS) design. The central hypothesis is that PAS may increase or decrease connectivity between the stimulated areas depending on the asynchrony value. All techniques in the study are non-invasive and considered safe.
Status | Not yet recruiting |
Enrollment | 80 |
Est. completion date | March 31, 2027 |
Est. primary completion date | March 31, 2027 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 64 Years |
Eligibility | Inclusion Criteria: - Healthy - Normal hearing and (corrected) vision - Able to understand and give informed consent Exclusion Criteria: - Metal in the body (rods, plates, screws, shrapnel, dentures, IUD) - Metallic particles in the eye - Surgical clips in the head or previous neurosurgery - Cardiac pacemaker or pacemaker wires - Neurostimulators - Implanted pumps - Any magnetic particles in the body - Cochlear implants - Prosthetic heart valves - Epilepsy or any other type of seizure history - Significant claustrophobia - Meniere's disease - Pregnancy or breast-feeding - Diagnoses or medications (neurological or psychiatric) influencing brain function - History of, or current, substance abuse - History of developmental disorders (e.g., dyslexia) - Failure to perform the behavioral tasks - Prisoners |
Country | Name | City | State |
---|---|---|---|
United States | Mass General Brigham | Charlestown | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Massachusetts General Hospital |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Cortico-cortical evoked potential (ccEP) latencies | EEG/EMG are recorded with a 64/16-channel TMS-compatible device (NeurOne, Bittium, Kuopio, Finland) while spTMS is delivered. Thereafter, the sensor-space evoked potentials (EPs) undergo EEG source analysis to produce source-space ccEPs. For sessions with uni-focal TMS, the ccEPs latencies are used for determining the inter-regional conduction delays. | Recorded in the uni-focal TMS session, on average on Day 14 (Session 2). The ccEPs are measured once for each TMS location and intensity. | |
Primary | Change in cortico-cortical evoked potential (ccEP) amplitudes | EEG/EMG are recorded with a 64/16-channel TMS-compatible device (NeurOne, Bittium, Kuopio, Finland) while spTMS is delivered. Thereafter, the sensor-space evoked potentials (EPs) undergo EEG source analysis to produce source-space ccEPs. For sessions with bi-focal TMS (PAS), the ccEPs amplitudes are used for determining the within-session effects of PAS by measuring the change in amplitudes before versus after the PAS modulation. | Recorded in each bi-focal TMS (PAS) session, on average on Days 28, 35, and 42 (Sessions 3, 4, and 5, respectively). | |
Secondary | MRI structural connectivity | Diffusion MRI will be used to assess structural connectivity strengths between the stimulated areas in bi-focal TMS (PAS). The structural connectivity strengths will be compared with EEG-derived connectivity strengths. | Once on Day 1 (Session 1, before first TMS session). | |
Secondary | MRI functional connectivity | Resting-state fMRI will be used to assess functional connectivity strengths between the stimulated areas in bi-focal TMS (PAS). The functional connectivity strengths will be compared with EEG-derived connectivity strengths. | Once on Day 1 (Session 1, before first TMS session). | |
Secondary | Change in bimanual coordination task (BCT) performance | Behavioral measures of inter-hemispheric communication between the left and right motor cortices will be recorded with the BCT. Change is measured by comparing performance before vs. after the PAS modulation. | Recorded in each bi-focal TMS (PAS) session, on average on Days 28, 35, and 42 (Sessions 3, 4, and 5, respectively). | |
Secondary | Change in resting-state EEG (rs-EEG) connectivity using phase slope index (PSI) | EEG/EMG are recorded with a 64/16-channel TMS-compatible device (NeurOne, Bittium, Kuopio, Finland) during rest. Thereafter, unaveraged source-space time courses are extracted from the sensor-space EEG using source analysis techniques. The source-space time courses from the stimulated areas are analyzed for signs of connectivity changes by comparing the within-session PSI values before versus after the PAS modulation. | Recorded in each bi-focal TMS (PAS) session, on average on Days 28, 35, and 42 (Sessions 3, 4, and 5, respectively). |
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