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

Sponsor
Aalborg University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05714020
Collaborator
(none)
30
1
2
22.9
1.3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Real rTMS
  • Other: Sham rTMS
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Single (Participant)
Primary Purpose:
Basic Science
Official Title:
Effects of High-frequency rTMS on Brain Connectivity
Actual Study Start Date :
Feb 1, 2023
Anticipated Primary Completion Date :
May 30, 2023
Anticipated Study Completion Date :
Dec 30, 2024

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Real rTMS

The 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.

Other: Real rTMS
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 Comparator: Sham rTMS

The 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.

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

Outcome Measures

Primary Outcome Measures

  1. Cortical connectivity [Cortical connectivity changes will be investigated before and after rTMS (1 hour)]

    Global and local mean field amplitude

Secondary Outcome Measures

  1. Cortical excitability [Cortical excitability changes will be investigated before and after rTMS (1 hour)]

    TMS-evoked potentials

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Healthy men and women

  • Speak and understand English

Exclusion Criteria:
  • 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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Aalborg University Aalborg Nordjylland Denmark 9000

Sponsors and Collaborators

  • Aalborg University

Investigators

  • Principal Investigator: Enrico De Martino, MD, PhD, Aalborg University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Enrico De Martino, Principal Investigator, Aalborg University
ClinicalTrials.gov Identifier:
NCT05714020
Other Study ID Numbers:
  • N-20220018-1
First Posted:
Feb 6, 2023
Last Update Posted:
Feb 6, 2023
Last Verified:
Feb 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Feb 6, 2023