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Repetitive Transcranial Magnetic StimulationrTMS-TMS-EEGNCT05714020

TMS-evoked Potentials During Repetitive Transcranial Magnetic Stimulation on the Primary Motor Cortex

A study testing Real rTMS in people with Repetitive Transcranial Magnetic Stimulation and Motor Cortex, run by Aalborg University at 1 site in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 60 yearsHealthy volunteers can take part
What is being tested?
Real rTMS
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
30 participants
Where
1 siteDenmark
Study dates
1 Feb 2023to 30 Dec 2024
Phase
Interventional
Are there results?
None posted in the registry

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.

Denmark1 site
  • Aalborg University

    Gistrup, North Denmark, 9260

Other trials in Denmark

About this study

Official title: Effects of High-frequency RTMS on Brain Connectivity

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.

Read the detailed description

Abnormal connectivity patterns interfere with the normal function of a given neuronal network, thus leading to circuit dysfunction and, subsequently, chronic pain. In the last few years, neuroscience has been heavily influenced by network science. This synergistic association provided a new framework for understanding brain function in health and how dysfunction in specific neuronal brain circuits can lead to symptoms. A network comprises nodes (e.g., areas of the brain) and edges (functional connections between nodes). An effective network can process and share large amounts of information while maintaining specificity and not allowing noise to contaminate the flow of information across the circuits. The network approach to brain functioning has been able to integrate what has been known for several decades as spatial structural anatomy with the time-varying streaming of information (connectivity) in a dynamic perspective. In this context, symptoms of diseases are seen as being correlated with specific network abnormalities, and therapeutic interventions as being associated with the normalisation of these abnormal patterns of connection. Non-invasive neuromodulatory approaches, such as repetitive transcranial magnetic stimulation (rTMS), have entered the guidelines for the management of major depression refractory to pharmacological treatment (FDA clearance in 2008 - K061053) and several chronic pain conditions, providing low-adverse event, rapid-to-perform and safe non-pharmacological treatment possibilities for neuropsychiatric disorders. rTMS is based on the induction of a high-intensity magnetic field on the scalp and on the subsequent creation of an induced electric current that penetrates the skull and influences neuronal firing over a very restricted volume of the brain. Depending on stimulation parameters, rTMS also acts by facilitating or depressing the activity of specific brain networks non-invasively. Despite important advances in the use of rTMS, and similar to what is also obtained from pharmacological treatments, up to 40% of patients remain symptomatic after treatment. This study aims to investigate the responses of specific neuronal brain circuits to repetitive transcranial magnetic stimulation (rTMS) applied to the primary motor cortex in healthy volunteers. It has been hypothesised that the local-to-global connectivity pattern obtained by the stimulation of different cortical hubs (primary motor cortex, dorsolateral prefrontal cortex, anterior cingulate cortex and posterior insula) will be described by TMS-EEG responses in healthy individuals. The modification in cortical connectivity in response to a repetitive transcranial magnetic stimulation (rTMS) applied to the primary motor cortex will be described and compared with a sham rTMS stimulation.

Being tested
Real rTMS, Sham rTMS

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Real 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.

  • Sham rTMSOther

    A sham coil is also used to mimic the clicking sound of the transcranial magnetic coil and skin stimulation.

Study groups in NCT05714020
Study groupRoleWhat they receive
Real rTMSActive 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.
Receives: Other: Real rTMS
Sham rTMSSham 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.
Receives: Other: Sham rTMS

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cortical connectivity

    Global and local mean field amplitude

    Measured: Cortical connectivity changes will be investigated before and after rTMS (1 hour)

Secondary outcomes (1)
  1. Cortical excitability

    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.

  1. First posted6 Feb 2023
  2. Study start1 Feb 2023
  3. Primary completion30 May 2023
  4. Study completion30 Dec 2024

Resources

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
Randomised
Intervention model
Crossover
Masking
Single blind
Who is masked
Participant
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05714020
Sponsor's protocol ID
N-20220018-1
Acronym
rTMS-TMS-EEG
Status last verified
Feb 2025
First submitted
25 Jan 2023
Last updated
5 Feb 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Real rTMS in people with Repetitive Transcranial Magnetic Stimulation and Motor Cortex, 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: finished, as of the sponsor's last update on 5 Feb 2025. 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. Some participants in this study may receive a placebo. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. 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 5 Feb 2025.

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