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

  • STATUS
    Recruiting
  • End date
    Sep 11, 2025
  • participants needed
    300
  • sponsor
    University Hospital Inselspital, Berne
Updated on 11 March 2022
Accepts healthy volunteers

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.

Details
Condition Functional Neurological Symptom Disorder, Neurological Diseases or Conditions
Treatment Psychoeducation, Virtual Reality, Neurofeedback, Mindfulness-based stress reduction therapy, Inhibitory TMS, TMS sham, Excitatory TMS
Clinical Study IdentifierNCT05086380
SponsorUniversity Hospital Inselspital, Berne
Last Modified on11 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Patients
A diagnosis of a neuropsychiatric disorder (such as FND, GTS, PPD, anxiety or depression or others) according to DSM-5 diagnostic 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

Presence of comorbid psychiatric disorders such as psychosis, current major and severe depression episode, autistic spectrum disorder
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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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