Modulation of Sense of Agency With Non-invasive Brain Stimulation and Mindfulness-based Stress Reduction Therapy
NCT ID: NCT05086380
Last Updated: 2025-03-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
190 participants
INTERVENTIONAL
2021-12-10
2024-12-16
Brief Summary
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This study investigates the effects of transcranial magnetic stimulation (TMS) on the general well-being and symptoms of conversion disorder and other neurological disorders and in comparison to healthy subjects. The TMS method allows to target specific areas of the brain by means of magnetic fields. This technique is not painful and does not have long-lasting effects.
In addition, the study investigates the effects of mindfulness-based stress reduction on the general well-being and symptoms of conversion disorder and other neurological disorders and compared to healthy subjects. This technique is not painful and has no long-lasting effects.
Furthermore, the study examines movement patterns and symptoms of patients compared to healthy controls while they are in a virtual reality.
Finally, the study examines patients' brain activity while playing a game targeting the sense of agency in real time, which is recorded with an MRI scanner.
The study includes a maximum of twelve sessions in total (ten sessions of approximately 1.5-2 hours each and two sessions each overnight). The planned study methods include TMS, (real-time and normal) magnetic resonance tomography of the brain (MRI "tube"), virtual- and augmented reality (AR/VR), questionnaires, blood, saliva, and motion sensors (e.g., fitness bracelet), and participation in the 8-week mindfulness program.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
SINGLE
Study Groups
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FND Patients Experimental
Group of patients with functional neurological disorders
Mindfulness-based stress reduction therapy
MBSR Therapy is a structured 8-week program that employs mindfulness meditation to alleviate suffering associated with physical, psychosomatic and psychiatric disorders. The program is based upon a systematic procedure to develop enhanced awareness of moment-to-moment experience of perceptible mental processes.
Inhibitory TMS
The device will be used to neuromodulate the right TPJ of participants' brain using cTBS stimulation protocol for transcranial magnetic stimulation
TMS sham
The device will be used to neuromodulate the right TPJ of participants' brain using transcranial magnetic stimulation over the vertex
Excitatory TMS
The device will be used to neuromodulate the right TPJ of participants' brain using iTBS stimulation protocol for transcranial magnetic stimulation
Virtual Reality
The device will be used to manipulate the perception of symptoms of patients while they are playing a game in virtual/augmented reality.
Neurofeedback
Neurofeedback training will be applied in patients while laying in an MRI scanner. Patients will play a game, which targets the sense of agency, and will receive a real-time feedback about their performance and brain activity. They will learn to self-regulate their performance on the game in order to increase brain activity relevant for the sense of agency.
Organic controls
Group of patients with organic neurological disorders
Inhibitory TMS
The device will be used to neuromodulate the right TPJ of participants' brain using cTBS stimulation protocol for transcranial magnetic stimulation
TMS sham
The device will be used to neuromodulate the right TPJ of participants' brain using transcranial magnetic stimulation over the vertex
Excitatory TMS
The device will be used to neuromodulate the right TPJ of participants' brain using iTBS stimulation protocol for transcranial magnetic stimulation
Healthy controls
Group of healthy controls
Inhibitory TMS
The device will be used to neuromodulate the right TPJ of participants' brain using cTBS stimulation protocol for transcranial magnetic stimulation
TMS sham
The device will be used to neuromodulate the right TPJ of participants' brain using transcranial magnetic stimulation over the vertex
Excitatory TMS
The device will be used to neuromodulate the right TPJ of participants' brain using iTBS stimulation protocol for transcranial magnetic stimulation
Virtual Reality
The device will be used to manipulate the perception of symptoms of patients while they are playing a game in virtual/augmented reality.
FND Patients Comparator
Group of patients with functional neurological disorders
Inhibitory TMS
The device will be used to neuromodulate the right TPJ of participants' brain using cTBS stimulation protocol for transcranial magnetic stimulation
Psychoeducation
Participants will learn about the symptoms and how to cope with the symptoms
TMS sham
The device will be used to neuromodulate the right TPJ of participants' brain using transcranial magnetic stimulation over the vertex
Excitatory TMS
The device will be used to neuromodulate the right TPJ of participants' brain using iTBS stimulation protocol for transcranial magnetic stimulation
Neurofeedback
Neurofeedback training will be applied in patients while laying in an MRI scanner. Patients will play a game, which targets the sense of agency, and will receive a real-time feedback about their performance and brain activity. They will learn to self-regulate their performance on the game in order to increase brain activity relevant for the sense of agency.
Interventions
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Mindfulness-based stress reduction therapy
MBSR Therapy is a structured 8-week program that employs mindfulness meditation to alleviate suffering associated with physical, psychosomatic and psychiatric disorders. The program is based upon a systematic procedure to develop enhanced awareness of moment-to-moment experience of perceptible mental processes.
Inhibitory TMS
The device will be used to neuromodulate the right TPJ of participants' brain using cTBS stimulation protocol for transcranial magnetic stimulation
Psychoeducation
Participants will learn about the symptoms and how to cope with the symptoms
TMS sham
The device will be used to neuromodulate the right TPJ of participants' brain using transcranial magnetic stimulation over the vertex
Excitatory TMS
The device will be used to neuromodulate the right TPJ of participants' brain using iTBS stimulation protocol for transcranial magnetic stimulation
Virtual Reality
The device will be used to manipulate the perception of symptoms of patients while they are playing a game in virtual/augmented reality.
Neurofeedback
Neurofeedback training will be applied in patients while laying in an MRI scanner. Patients will play a game, which targets the sense of agency, and will receive a real-time feedback about their performance and brain activity. They will learn to self-regulate their performance on the game in order to increase brain activity relevant for the sense of agency.
Eligibility Criteria
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Inclusion Criteria
* A diagnosis of a functional disorder (such as FND, GTS, PPD, anxiety or depression or others) according to DSM-5 diagnostic and ICD-11 criteria, or
* A diagnosis of an organic neurological disorder such as stroke, multiple sclerosis (MS), neuromuscular, or movement disorder
* Aged \> 16 years old
* Willing to participate in the study (by signing the ICF)
* Capable of judgement
healthy controls:
* Aged \> 16 years old
* Willing to participate in the study (by signing the ICF)
* Capable of judgement
Exclusion Criteria
* Past surgery in the brain
* History of alcohol or drug abuse
* Botulinum toxin injection in last 3 month
* Inability to follow the procedure of the study, e.g., due to language problems
* For organic disorders only: Active severe aphasia, dementia, neglect and acute confusional state, severe pain
* For female participants: breastfeeding, pregnancy or intention to become pregnant (assessed with standard urine test prior to the enrolment in the experiment and before each visit)
* For MRI and TMS part only: Past surgery in the brain
* For MRI and TMS part only: Implanted medical devices not-compatible with MRI or TMS (e.g., cochlear implants, infusion pumps, neurostimulators, cardiac pacemakers)
* For TMS part only: History of actual or suspected epilepsy
* For TMS part only: Suspected or diagnosed labile or hypertensive blood pressure
* For Virtual Reality only: No cybersickness
17 Years
ALL
Yes
Sponsors
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Insel Gruppe AG, University Hospital Bern
OTHER
University of Fribourg
OTHER
Responsible Party
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Principal Investigators
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Selma Aybek, MD
Role: PRINCIPAL_INVESTIGATOR
University of Fribourg
Locations
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University of Fribourg
Fribourg, , Switzerland
Countries
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Other Identifiers
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2020-02283
Identifier Type: -
Identifier Source: org_study_id
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