TMS-evoked Potentials During Repetitive Transcranial Magnetic Stimulation on the Primary Motor Cortex
rTMS-TMS-EEG
Effects of High-frequency RTMS on Brain Connectivity
1 other identifier
interventional
30
1 country
1
Brief Summary
This study investigates the modification of the local-to-global connectivity pattern in response to a session of repetitive transcranial magnetic stimulation (rTMS) applied to the primary motor cortex. Transcranial magnetic stimulation (TMS) will be applied to elicit electroencephalography (EEG) responses in healthy volunteers. The TMS-evoked potentials (TEPs) will be recorded and serve as a reflection of cortical reactivity to TMS.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Feb 2023
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 25, 2023
CompletedStudy Start
First participant enrolled
February 1, 2023
CompletedFirst Posted
Study publicly available on registry
February 6, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2024
CompletedFebruary 5, 2025
February 1, 2025
4 months
January 25, 2023
February 1, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Cortical connectivity
Global and local mean field amplitude
Cortical connectivity changes will be investigated before and after rTMS (1 hour)
Secondary Outcomes (1)
Cortical excitability
Cortical excitability changes will be investigated before and after rTMS (1 hour)
Study Arms (2)
Real rTMS
ACTIVE COMPARATORThe active rTMS protocol is a 15-minute 10Hz stimulation, 10 seconds on, 20 seconds off, at 90% RMT, for a total of 3000 pulses using a real TMS coil. The target is the primary motor cortex.
Sham rTMS
SHAM COMPARATORThe sham rTMS protocol is performed by a sham coil. The sham rTMS protocol is a 15-minute 10Hz stimulation, 10 seconds on, 20 seconds off, at 90% RMT, for a total of 3000 pulses. The target is the primary motor cortex.
Interventions
Repetitive transcranial magnetic stimulation (rTMS) is applied to the primary motor cortex. The protocol consists of 15 minutes of 10Hz stimulation, 10 seconds on, 20 seconds off, at 90% RMT, for a total of 3000 pulses.
A sham coil is also used to mimic the clicking sound of the transcranial magnetic coil and skin stimulation.
Eligibility Criteria
You may qualify if:
- Healthy men and women
- Speak and understand English
You may not qualify if:
- Drug addiction defined as the use of cannabis, opioids or other drugs
- Previous neurologic, musculoskeletal or mental illnesses
- Lack of ability to cooperate
- History of chronic pain or current acute pain
- Contraindications to rTMS application (history of epilepsy, metal in the head or jaw etc.).
- Failure to pass the "TASS questionnaire" (TASS = Transcranial Magnetic Stimulation Adult Safety Screen)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Aalborg University
Gistrup, North Denmark, 9260, Denmark
Study Officials
- PRINCIPAL INVESTIGATOR
Enrico De Martino, MD, PhD
Aalborg University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
January 25, 2023
First Posted
February 6, 2023
Study Start
February 1, 2023
Primary Completion
May 30, 2023
Study Completion
December 30, 2024
Last Updated
February 5, 2025
Record last verified: 2025-02