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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05086380
Recruitment Status : Not yet recruiting
First Posted : October 20, 2021
Last Update Posted : October 20, 2021
Sponsor:
Information provided by (Responsible Party):
University Hospital Inselspital, Berne

Brief Summary:

A conversion disorder is a dysfunction of the nervous system in which no structural or organic 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.

The study includes a maximum of seven sessions in total (five sessions of approximately 1.5-2 hours each and two sessions each overnight). The planned study methods include TMS, Magnetic resonance tomography of the brain (MRI "tube"), questionnaires, blood, saliva, and motion sensors (e.g., fitness bracelet), and participation in the 8-week mindfulness program.


Condition or disease Intervention/treatment Phase
Functional Neurological Symptom Disorder Neurological Diseases or Conditions Behavioral: Mindfulness-based stress reduction therapy Device: Inhibitory TMS Behavioral: Psychoeducation Device: TMS sham Device: Excitatory TMS Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Modulation of the Sense of Agency Across Different Neurological Disorders Using Non-invasive Brain Stimulation and Mindfulness-based Stress Reduction Therapy
Estimated Study Start Date : January 2022
Estimated Primary Completion Date : September 2025
Estimated Study Completion Date : September 2025

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: FND Patients Experimental
Group of patients with functional neurological disorders
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

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

Active Comparator: Organic controls
Group of patients with organic neurological disorders
Device: Inhibitory TMS
The device will be used to neuromodulate the right TPJ of participants' brain using cTBS stimulation protocol for transcranial magnetic stimulation

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

Active Comparator: Healthy controls
Group of healthy controls
Device: Inhibitory TMS
The device will be used to neuromodulate the right TPJ of participants' brain using cTBS stimulation protocol for transcranial magnetic stimulation

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

Active Comparator: FND Patients Comparator
Group of patients with functional neurological disorders
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




Primary Outcome Measures :
  1. Change in objective Performance Agency Task (TMS) [ Time Frame: Visit 1 (at baseline), visit 2 (one week after baseline), visit 3 (two weeks after baseline) ]
    The changes in objective performance on the behavioural tasks targeting the sense of agency using the score of an agency task played in the Magnetic Resonance Imaging (MRI) scanner, on a computer or in Virtual Reality before and after brain stimulation (transcranial magnetic stimulation, TMS). The performance is measured by counting the number of targets hit minus the number of obstacles hit during the computer game [-].

  2. Change in subjective Performance Agency Task (TMS) [ Time Frame: Visit 1 (at baseline), visit 2 (one week after baseline), visit 3 (two weeks after baseline) ]
    The changes in objective and subjective performance on the behavioural tasks targeting the sense of agency using questionnaires before and after brain stimulation. Participants rate their performance on a visual analog scale (VAS) from 0 to 10 [-].

  3. Change in objective Performance Agency Task (MBSR) [ Time Frame: Visit 4 (at least 1 week after visit 3), visit 5 (8 weeks after visit 4) ]
    The objective performance on the behavioural tasks targeting the sense of agency using the score of an agency task played in the MRI scanner, on a computer or in Virtual Reality before and after a therapeutic intervention (mindfulness-based stress reduction, MBSR).The performance is measured by counting the number of targets hit minus the number of obstacles hit during the computer game [-].

  4. Change in subjective Performance Agency Task (MBSR) [ Time Frame: Visit 4 (at least 1 week after visit 3), visit 5 (8 weeks after visit 4) ]
    The subjective performance on the behavioural tasks targeting the sense of agency using questionnaires before and after a therapeutic intervention (MBSR). Participants rate their performance on a visual analog scale (VAS) from 0 to 10 [-].


Secondary Outcome Measures :
  1. task-based fMRI measures TMS [ Time Frame: Visit 1 (at baseline), visit 2 (one week after baseline), visit 3 (two weeks after baseline) ]
    The functional magnetic resonance imaging (fMRI) measures of blood oxygenation signal (BOLD) in the whole brain during the behavioural task before and after excitatory, inhibitory or sham rTMS, in patients affected by a functional neuropsychiatric disorder (e.g., FND, Gilles de la Tourette Syndrome (GTS), Psychosomatic Pain Disorder (PPD)), in comparison to patients affected by an organic condition (e.g., Dystonia, Stroke) and healthy subjects. BOLD is measured in change in intensity between conditions with conditions being before and after rTMS [-].

  2. resting-state fMRI measures TMS [ Time Frame: Visit 1 (at baseline), visit 2 (one week after baseline), visit 3 (two weeks after baseline) ]
    The fMRI measures of blood oxygenation in the whole brain at rest, before and after excitatory, inhibitory or sham rTMS, in patients affected by a functional neuropsychiatric disorder (e.g., FND, GTS, PPD), in comparison to patients affected by an organic condition (e.g., Dystonia, Stroke) and healthy subjects. BOLD is measured in change in functional connectivity between conditions with conditions being before and after rTMS. Functional connectivity is calculated using Pearson's correlation coefficient between pairs of brain regions [-].

  3. DTI measures TMS [ Time Frame: Visit 1 (at baseline), visit 2 (one week after baseline), visit 3 (two weeks after baseline) ]
    The fMRI measures of blood oxygenation in the whole brain using diffusion tensor imaging (DTI), before and after excitatory, inhibitory or sham rTMS, in patients affected by a functional neuropsychiatric disorder (e.g., FND, GTS, PPD), in comparison to patients affected by an organic condition (e.g., Dystonia, Stroke) and healthy subjects. DTI measures the direction and strengths of white matter fibre tracts by measuring the diffusion of water molecules. The measured quantity is the diffusivity or diffusion coefficient, a proportionality constant that relates diffusive flux to a concentration gradient [mm2/s].

  4. task-based fMRI measures MBSR [ Time Frame: Visit 4 (at least 1 week after visit 3), visit 5 (8 weeks after visit 4) ]
    The fMRI measures of blood oxygenation in the whole brain during the behavioural task, before and after MBSR or psychoeducation, in patients affected by a functional neuropsychiatric disorder (e.g., FND, GTS, PPD), in comparison to patients affected by an organic condition (e.g., Dystonia, Stroke). BOLD is measured in change in intensity between conditions with conditions being before and after rTMS [-].

  5. resting-state fMRI measures MBSR [ Time Frame: Visit 4 (at least 1 week after visit 3), visit 5 (8 weeks after visit 4) ]
    The fMRI measures of blood oxygenation in the whole brain at rest before and after MBSR or psychoeducation, in patients affected by a functional neuropsychiatric disorder (e.g., FND, GTS, PPD), in comparison to patients affected by an organic condition (e.g., Dystonia, Stroke). BOLD is measured in change in functional connectivity between conditions with conditions being before and after rTMS. Functional connectivity is calculated using Pearson's correlation coefficient between pairs of brain regions [-].

  6. DTI measures MBSR [ Time Frame: Visit 4 (at least 1 week after visit 3), visit 5 (8 weeks after visit 4) ]
    The fMRI measures of blood oxygenation in the whole brain during DTI, before and after MBSR or psychoeducation, in patients affected by a functional neuropsychiatric disorder (e.g., FND, GTS, PPD), in comparison to patients affected by an organic condition (e.g., Dystonia, Stroke). DTI measures the direction and strengths of white matter fibre tracts by measuring the diffusion of water molecules. The measured quantity is the diffusivity or diffusion coefficient, a proportionality constant that relates diffusive flux to a concentration gradient [mm2/s].

  7. Subjective Agency TMS [ Time Frame: Visit 1 (at baseline), visit 2 (one week after baseline), visit 3 (two weeks after baseline) ]
    Subjective assessment of own agency during a behavioural task, before and after excitatory, inhibitory or sham rTMS, in patients affected by a functional neuropsychiatric disorder (e.g., FND, Gilles de la Tourette Syndrome (GTS), Psychosomatic Pain Disorder (PPD)), in comparison to patients affected by an organic condition (e.g., Dystonia, Stroke) and healthy subjects. Participants rate their performance on a visual analog scale (VAS) from 0 to 10 [-].

  8. Subjective Agency MBSR [ Time Frame: Visit 4 (at least 1 week after visit 3), visit 5 (8 weeks after visit 4) ]
    Subjective assessment of own agency during a behavioural task, before and after MBSR or psychoeducation, in patients affected by a functional neuropsychiatric disorder (e.g., FND, GTS, PPD), in comparison to patients affected by an organic condition (e.g., Dystonia, Stroke). Participants rate their performance on a visual analog scale (VAS) from 0 to 10 [-].

  9. Neurological Examination TMS [ Time Frame: Visit 1 (at baseline), visit 2 (one week after baseline), visit 3 (two weeks after baseline) ]
    The performance on an objective neurological examination, before and after excitatory, inhibitory or sham rTMS, in patients affected by a functional neuropsychiatric disorder (e.g., FND, Gilles de la Tourette Syndrome (GTS), Psychosomatic Pain Disorder (PPD)), in comparison to patients affected by an organic condition (e.g., Dystonia, Stroke). Patients will be examined according to standardized medical examination tests (e.g., positive signs & A Simplified Version of the Psychogenic Movement Disorders Scale (S-FMDRS) for FND).

  10. Neurological Examination MBSR [ Time Frame: Visit 4 (at least 1 week after visit 3), visit 5 (8 weeks after visit 4) ]
    The performance on an objective neurological examination, before and after MBSR or psychoeducation in patients affected by a functional neuropsychiatric disorder (e.g., FND, GTS, PPD), in comparison to patients affected by an organic condition (e.g., Dystonia, Stroke). Patients will be examined according to standardized medical examination tests (e.g., positive signs & A Simplified Version of the Psychogenic Movement Disorders Scale (S-FMDRS) for FND).

  11. Objective stress parameters pre/post [ Time Frame: Visit 4 (at least 1 week after visit 3), visit 5 (8 weeks after visit 4) ]
    The stress parameters assessed using salivary cortisol before and after MBSR Therapy compared to psychoeducation, in patients affected by a functional neuropsychiatric disorder, an organic condition or in healthy subjects. Cortisol levels are measured using Enzyme-linked Immunosorbent Assay (ELISA) [ng/ul].

  12. Subjective stress parameters pre/post [ Time Frame: Visit 4 (at least 1 week after visit 3), visit 5 (8 weeks after visit 4) ]
    Subjective stress before and after MBSR Therapy compared to psychoeducation, in patients affected by a functional neuropsychiatric disorder, an organic condition or in healthy subjects. Subjective stress is measured using a VAS from 0-100.

  13. Sleep [ Time Frame: Visit 4 (at least 1 week after visit 3), visit 5 (8 weeks after visit 4) ]
    The outcomes of ambient sensors (i.e., actigraphs) monitor non-invasively everyday life activity (ELA), including sleep, in patients affected by a functional neuropsychiatric disorder, an organic condition or in healthy subjects. Actigraphs measure light input and motion. A variety of outcome measures can be calculated such as Time in Bed, Time asleep,

  14. Neurofeedback [ Time Frame: Visit 1 (at baseline), visit 2 (one week after baseline), visit 3 (two weeks after baseline), visit 4 (at least 1 week after visit 3), visit 5 (8 weeks after visit 4) and follow up (6 month after visit 5) ]
    The real-time measures of blood oxygenation in the target areas (e.g., TPJ) in patients affected by a functional neuropsychiatric disorder (e.g., FND, GTS, PPD), in comparison to patients affected by an organic condition (e.g., Dystonia, Stroke) and healthy subjects. Participants will receive direct feedback on their performance in the scanner.

  15. Long-term effects on task-based fMRI measures MBSR [ Time Frame: At follow-up (6 month after visit 5) ]
    To measure the long-term (six months) effect of MBSR Therapy, the fMRI measures of blood oxygenation signal (BOLD) is measured in the whole brain during the behavioural task, in patients affected by a functional neuropsychiatric disorder (e.g., FND, Gilles de la Tourette Syndrome (GTS), Psychosomatic Pain Disorder (PPD)), in comparison to patients affected by an organic condition (e.g., Dystonia, Stroke) and healthy subjects. BOLD is measured in change in intensity between conditions with conditions being at follow-up compared to Visit 5 (after MBSR therapy)[-].

  16. Long-term effects on resting-state fMRI measures MBSR [ Time Frame: At follow-up (6 month after visit 5) ]
    To measure the long-term (six months) effect of MBSR Therapy, the fMRI measures of blood oxygenation signal (BOLD) is measured in the whole brain at rest, in patients affected by a functional neuropsychiatric disorder (e.g., FND, GTS, PPD), in comparison to patients affected by an organic condition (e.g., Dystonia, Stroke) and healthy subjects. BOLD is measured in change in functional connectivity between conditions with conditions being at follow-up compared to Visit 5 (after MBSR therapy). Functional connectivity is calculated using Pearson's correlation coefficient between pairs of brain regions [-]. .

  17. Long-term effects on DTI measures MBSR [ Time Frame: At follow-up (6 month after visit 5) ]
    To measure the long-term (six months) effect of MBSR Therapy, the fMRI measures of blood oxygenation signal (BOLD) is measured in the whole brain during DTI, in patients affected by a functional neuropsychiatric disorder (e.g., FND, GTS, PPD), in comparison to patients affected by an organic condition (e.g., Dystonia, Stroke) and healthy subjects. DTI measures the direction and strengths of white matter fibre tracts by measuring the diffusion of water molecules. The measured quantity is the diffusivity or diffusion coefficient, a proportionality constant that relates diffusive flux to a concentration gradient [mm2/s].

  18. Long-term effects on subjective agency MBSR [ Time Frame: At follow-up (6 month after visit 5) ]
    To measure the long-term (six months) effect of MBSR therapy, the subjective performance on the behavioural tasks targeting the sense of agency is used. Participants rate their agency on a visual analog scale (VAS) from 0 to 10 [-]. Subjective agency at follow-up will be compared to subjective agency at Visit 5 (after MBSR).

  19. Long-term effects on neurological examination MBSR [ Time Frame: At follow-up (6 month after visit 5) ]
    To measure the long-term (six months) effect of MBSR therapy, the performance on an objective neurological examination will be assessed, in patients affected by a functional neuropsychiatric disorder (e.g., FND, GTS, PPD), in comparison to patients affected by an organic condition (e.g., Dystonia, Stroke). Patients will be examined according to standardized medical examination tests (e.g., positive signs & A Simplified Version of the Psychogenic Movement Disorders Scale (S-FMDRS) for FND). Outcome of neurological assessment at follow-up will be compared to outcome of neurological assessment at Visit 5 (after MBSR).

  20. Long-term effects on objective performance [ Time Frame: At follow-up (6 month after visit 5) ]
    To measure the long-term (six months) effect of MBSR therapy, the objective performance on the behavioural tasks targeting the sense of agency is used. The performance is measured by counting the number of targets hit minus the number of obstacles hit during the computer game [-]. Objective performance at follow-up will be compared to objective performance at Visit 5 (after MBSR).

  21. Long-term effects on subjective performance [ Time Frame: At follow-up (6 month after visit 5) ]
    To measure the long-term (six months) effect of MBSR therapy, the subjective performance on the behavioural tasks targeting the sense of agency is used. Participants rate their performance on a visual analog scale (VAS) from 0 to 10 [-]. Objective performance at follow-up will be compared to objective performance at Visit 5 (after MBSR).

  22. Neurophysiological measures: MEP [ Time Frame: Visit 1 (at baseline), visit 2 (one week after baseline), visit 3 (two weeks after baseline), visit 4 (at least 1 week after visit 3), visit 5 (8 weeks after visit 4) and follow up (6 month after visit 5) ]
    Motor evoked potential (MEP) is measured by eliciting an action potential using non-invasive brain stimulation (TMS) over the motor cortex through the scalp [% TMS - max. intensity output]. Neurophysiological measures will be used to characterise movement disorders. We will compare MEPs in patients with a functional, or organic condition, to healthy subjects.

  23. Neurophysiological measures: MT [ Time Frame: Visit 1 (at baseline), visit 2 (one week after baseline), visit 3 (two weeks after baseline), visit 4 (at least 1 week after visit 3), visit 5 (8 weeks after visit 4) and follow up (6 month after visit 5) ]
    Motor threshold (MT) measures the intensity of a pulse which elicits a predefined MEP. Neurophysiological measures will be used to characterise movement disorders. We will compare MTs in patients with a functional, or organic condition, to healthy subjects.

  24. Neurophysiological measures: SICI [ Time Frame: Visit 1 (at baseline), visit 2 (one week after baseline), visit 3 (two weeks after baseline), visit 4 (at least 1 week after visit 3), visit 5 (8 weeks after visit 4) and follow up (6 month after visit 5) ]
    Short IntraCortical Inhibition (SICI) measures the reduction of the MEP occurring after weak (subthreshold) conditioning pulse followed by a supra-threshold test pulse at short interstimulus intervals (approximately 2 msec). Neurophysiological measures will be used to characterise movement disorders. We will compare SICIs in patients with a functional, or organic condition, to healthy subjects.

  25. Neurophysiological measures: LICI [ Time Frame: Visit 1 (at baseline), visit 2 (one week after baseline), visit 3 (two weeks after baseline), visit 4 (at least 1 week after visit 3), visit 5 (8 weeks after visit 4) and follow up (6 month after visit 5) ]
    Long IntraCortical Inhibition (LICI) measures the reduction of MEP, as described in Outcome 28, at long interstimulus intervals (between 50 and 200 msec), using supra-threshold paired stimulation. Neurophysiological measures will be used to characterise movement disorders. We will compare LICIs in patients with a functional, or organic condition, to healthy subjects.

  26. Neurophysiological measures CSP [ Time Frame: Visit 1 (at baseline), visit 2 (one week after baseline), visit 3 (two weeks after baseline), visit 4 (at least 1 week after visit 3), visit 5 (8 weeks after visit 4) and follow up (6 month after visit 5) ]
    Cortical Silent Period (CSP) measures the period of electromyography (EMG) silence before activity resumes baseline, following the MEP elicited by a pulse to the motor cortex during tonic contraction of a target muscle. Neurophysiological measures will be used to characterise movement disorders. We will compare CSPs in patients with a functional, or organic condition, to healthy subjects.

  27. Neurophysiological measures: PAS [ Time Frame: Visit 1 (at baseline), visit 2 (one week after baseline), visit 3 (two weeks after baseline), visit 4 (at least 1 week after visit 3), visit 5 (8 weeks after visit 4) and follow up (6 month after visit 5) ]
    Paired Associative Stimulation (PAS) measures the increase in the MEP amplitude following lowfrequency stimulation over the median nerve of the hand, paired with TMS over the motor cortex. This is an index for plasticity. Neurophysiological measures will be used to characterise movement disorders. We will compare CSPs in patients with a functional, or organic condition, to healthy subjects.

  28. Epigenetic profile [ Time Frame: 1st visit (baseline) ]
    Mean methylation rates of genes involved in the stress-pathway (i.e., Oxytocin, Serotonine, Dopamine, Glucocorticoid receptor) will be assessed in patients affected by a functional or organic disorder and healthy subjects using blood samples. Methylation profiles will be determined using the bisulfite - treatment method.

  29. Long-term fluctuations of objective stress parameters [ Time Frame: at follow-up (6 month after visit 5) ]
    To assess the long-term (six months) fluctuations of stress, salivary cortisol will be measured at follow-up in patients affected by a functional neuropsychiatric disorder, an organic condition or in healthy subjects. Cortisol levels are measured using Enzyme-linked Immunosorbent Assay (ELISA) [ng/ul].

  30. Long-term fluctuations of subjective stress parameters [ Time Frame: at follow-up (6 month after visit 5) ]
    To assess the long-term (six months) fluctuations of stress, subjective stress levels will be measured at follow-up in patients affected by a functional neuropsychiatric disorder, an organic condition or in healthy subjects. Subjective stress is measured using a VAS from 0-100.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   17 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05086380


Contacts
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Contact: Selma Aybek, MD +41 31 632 23 46 selma.aybek@insel.ch
Contact: Manuela Steinauer, BSc +41 31 632 83 62 manuela.steinauer@insel.ch

Locations
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Switzerland
Inselspital
Bern, Switzerland, 3010
Contact: Selma Aybek, MD       selma.aybek@insel.ch   
Contact: Manuela Steinauer, BSc       manuela.steinauer@insel.ch   
Sponsors and Collaborators
University Hospital Inselspital, Berne
Investigators
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Principal Investigator: Selma Aybek, MD University Hospital Inselspital, Berne
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Responsible Party: University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier: NCT05086380    
Other Study ID Numbers: 2020-02283
First Posted: October 20, 2021    Key Record Dates
Last Update Posted: October 20, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Nervous System Diseases
Conversion Disorder
Somatoform Disorders
Mental Disorders