Cortical PlasticityCORTEX-4NCT07580989
Network Effects of Left M1 rTMS: A TMS-EEG Study
A study testing rTMS in people with Cortical Plasticity, run by Aalborg University at 1 site in Denmark.
Trial summary
This study investigates the modification of connectivity patterns in response to one session of active 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Cortical Plasticity
- What is being tested?
- rTMS
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteDenmark
- Study dates
- 1 May 2026to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy men and women
- Speak and understand English
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
Aalborg University
Gistrup, 9260
Enrico De Martino, 91811183, edm@hst.aau.dk
About this study
Official title: Effects of Left Primary Motor Cortex rTMS on Cortical Connectivity Assessed With TMS-EEG Across Left M1, Right M1, Premotor, and Occipital Cortices
This study investigates the modification of connectivity patterns in response to one session of active 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. TMS-evoked potentials (TEPs) will be recorded before and after the rTMS session and will serve as a reflection of cortical connectivity to TMS. Four cortical targets will be stimulated for TMS-EEG assessment: left primary motor cortex, right primary motor cortex, left premotor cortex, and right occipital cortex.
Read the detailed description
This study aims to investigate the effects of repetitive transcranial magnetic stimulation (rTMS) applied to the left primary motor cortex (left M1) on cortical reactivity and brain connectivity in healthy volunteers using combined transcranial magnetic stimulation and electroencephalography (TMS-EEG).
Brain function depends on the dynamic interaction of distributed neuronal networks that allow efficient communication between cortical regions. Alterations in these connectivity patterns have been associated with several neurological and neuropsychiatric disorders, including chronic pain, depression, and motor dysfunction. Non-invasive neuromodulation techniques such as repetitive transcranial magnetic stimulation (rTMS) can influence cortical excitability and modulate activity within interconnected brain networks.
rTMS is a safe and non-invasive technique that uses rapidly changing magnetic fields to induce electrical currents in targeted cortical areas. Depending on the stimulation parameters, rTMS may facilitate or inhibit neuronal activity locally and across connected brain regions. Despite its increasing clinical use, the neurophysiological mechanisms through which rTMS modifies large-scale brain connectivity remain incompletely understood.
In this study, healthy volunteers will undergo TMS-EEG recordings before and after one session of active rTMS delivered over the left primary motor cortex. TMS pulses will be applied to four cortical targets - left primary motor cortex (M1), right primary motor cortex (M1), left premotor cortex, and right occipital cortex - in order to assess local cortical reactivity and the propagation of neural activity across distinct brain regions. TMS-evoked potentials (TEPs) recorded with EEG will serve as electrophysiological markers of cortical excitability and connectivity.
The study seeks to characterise how stimulation of the left M1 modulates both local and distributed cortical responses. Specifically, it is hypothesised that one session of active rTMS over the left M1 will induce measurable changes in TEPs and alter connectivity patterns across motor and non-motor cortical networks. These findings may contribute to a better understanding of the neurophysiological mechanisms underlying rTMS-induced plasticity and network modulation.
- Conditions
- Cortical Plasticity
- Being tested
- rTMS
- Keywords
- Motor cortex, rTMS, TMS-EEG, Visual cortex, Premotor cortex
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rTMSOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Active Comparator : Classical rTMS to M1 | Experimental | Not described Receives: Other: rTMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cortical connectivity
Global and local mean field amplitude
Measured: Cortical connectivity changes will be investigated before and after rTMS (1 hour)
Secondary outcomes (1)
Cortical connectivity
TMS-evoked potentials
Measured: Cortical excitability changes will be investigated before and after rTMS (1 hour)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2026
- Study start1 May 2026
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cortical PlasticityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aalborg University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Enrico De Martino, Aalborg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07580989
- Sponsor's protocol ID
- r N-20210047-7
- Acronym
- CORTEX-4
- Status last verified
- May 2026
- First submitted
- 6 May 2026
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Left Primary Motor Cortex rTMS on Cortical Connectivity Assessed With TMS-EEG Across Left M1, Right M1, Premotor, and Occipital Cortices
- ClinicalTrials.gov ID
- NCT07580989
- Acronym / sponsor ID
- CORTEX-4 / r N-20210047-7
- Conditions
- Cortical Plasticity
- Keywords
- Motor cortex, rTMS, TMS-EEG, Visual cortex, Premotor cortex
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Aalborg UniversityUniversity, hospital or other
- Study start
- 1 May 2026 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 12 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study investigates the modification of connectivity patterns in response to one session of active 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. TMS-evoked potentials (TEPs) will be recorded before and after the rTMS session and will serve as a reflection of cortical connectivity to TMS. Four cortical targets will be stimulated for TMS-EEG assessment: left primary motor cortex, right primary motor cortex, left premotor cortex, and right occipital cortex.
Detailed description
This study aims to investigate the effects of repetitive transcranial magnetic stimulation (rTMS) applied to the left primary motor cortex (left M1) on cortical reactivity and brain connectivity in healthy volunteers using combined transcranial magnetic stimulation and electroencephalography (TMS-EEG).
Brain function depends on the dynamic interaction of distributed neuronal networks that allow efficient communication between cortical regions. Alterations in these connectivity patterns have been associated with several neurological and neuropsychiatric disorders, including chronic pain, depression, and motor dysfunction. Non-invasive neuromodulation techniques such as repetitive transcranial magnetic stimulation (rTMS) can influence cortical excitability and modulate activity within interconnected brain networks.
rTMS is a safe and non-invasive technique that uses rapidly changing magnetic fields to induce electrical currents in targeted cortical areas. Depending on the stimulation parameters, rTMS may facilitate or inhibit neuronal activity locally and across connected brain regions. Despite its increasing clinical use, the neurophysiological mechanisms through which rTMS modifies large-scale brain connectivity remain incompletely understood.
In this study, healthy volunteers will undergo TMS-EEG recordings before and after one session of active rTMS delivered over the left primary motor cortex. TMS pulses will be applied to four cortical targets - left primary motor cortex (M1), right primary motor cortex (M1), left premotor cortex, and right occipital cortex - in order to assess local cortical reactivity and the propagation of neural activity across distinct brain regions. TMS-evoked potentials (TEPs) recorded with EEG will serve as electrophysiological markers of cortical excitability and connectivity.
The study seeks to characterise how stimulation of the left M1 modulates both local and distributed cortical responses. Specifically, it is hypothesised that one session of active rTMS over the left M1 will induce measurable changes in TEPs and alter connectivity patterns across motor and non-motor cortical networks. These findings may contribute to a better understanding of the neurophysiological mechanisms underlying rTMS-induced plasticity and network modulation.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Active Comparator : Classical rTMS to M1 | Experimental | Other: rTMS |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy men and women
- Speak and understand English
Key exclusion criteria (6 listed)
- 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.).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| rTMSRepetitive 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. | Other | Active Comparator : Classical rTMS to M1 |
Primary outcome
Cortical connectivity
Time frame: Cortical connectivity changes will be investigated before and after rTMS (1 hour)
Global and local mean field amplitude
1 secondary outcome
Cortical connectivity
Time frame: Cortical excitability changes will be investigated before and after rTMS (1 hour)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing rTMS in people with Cortical Plasticity, run by Aalborg University at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Enrico De Martino (+4591811183, edm@hst.aau.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cortical connectivity (time frame: Cortical connectivity changes will be investigated before and after rTMS (1 hour)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2026.