NCT05086380

Modulation of Sense of Agency With Non-invasive Brain Stimulation and Mindfulness-based Stress Reduction Therapy

Modulation of the Sense of Agency Across Different Neurological Disorders Using Non-invasive Brain Stimulation and Mindfulness-based Stress Reduction Therapy

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 190 (actual)
• Sponsor: University of Fribourg · Academic / Other
• Sex: All
• Age: 17 Years
• Healthy volunteers: Accepted

Summary

A conversion disorder is a dysfunction of the nervous system in which no structural damage can be demonstrated. However, it must be distinguished from other psychiatric disorders such as psychosis or depression. There are a variety of signs of the disease, such as muscle paralysis, uncontrolled tremors or cramps. In rarer cases, blindness, deafness or numbness may occur. Diagnosing this complex disorder has always been a challenge for neurologists and psychiatrists. 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.

Conditions

• Functional Neurological Symptom Disorder
• Neurological Diseases or Conditions

Interventions

Type	Name	Description
BEHAVIORAL	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.
DEVICE	Inhibitory TMS	The device will be used to neuromodulate the right TPJ of participants' brain using cTBS stimulation protocol for transcranial magnetic stimulation
BEHAVIORAL	Psychoeducation	Participants will learn about the symptoms and how to cope with the symptoms
DEVICE	TMS sham	The device will be used to neuromodulate the right TPJ of participants' brain using transcranial magnetic stimulation over the vertex
DEVICE	Excitatory TMS	The device will be used to neuromodulate the right TPJ of participants' brain using iTBS stimulation protocol for transcranial magnetic stimulation
DEVICE	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.
BEHAVIORAL	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.

Timeline

• Start date: 2021-12-10
• Primary completion: 2024-12-16
• Completion: 2024-12-16
• First posted: 2021-10-20
• Last updated: 2025-03-04

Locations

1 site across 1 country: Switzerland