An observational study in Functional Neurological Disorder, sponsored by Explorations Fonctionnelles Avicenne. Status unknown at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-12-12.
Sponsored by Explorations Fonctionnelles Avicenne · Observational
Functional neurological disorders (FND) are motor, sensory or cognitive symptoms without an identified lesion. This is a very common reason for consultation in neurology. Transcranial magnetic stimulation (TMS) may be performed in these patients both for diagnostic purposes (in the context of motor evoked potentials) and for therapeutic purposes. The main objective of the study is to evaluate tolerability of TMS in patients with FND, in particular the pain caused by stimulation and the possible modification of painful or non-painful symptoms generated by this TMS. The secondary objectives are to assess chronic pain symptoms of these patients quantitatively and qualitatively, to assess expectations of these patients with regard to the performed examinations and to assess their expectations regarding magnetic stimulation performed for therapeutic purposes.
The investigators have therefore developped a questionnaire that will be submitted to all consecutive patients who meet the inclusion criteria and who have given their consent to participate. This questionnaire will be performed in three phases: 1) a few minutes before the realization of evoked potentials and TMS 2) 10 minutes after evoked potentials and TMS 3) two weeks after evoked potentials and TMS (by telephone).
The data collected will be:
- Phase 1 (a few minutes before the explorations): Quantitative assessment of pain Brief Pain inventory Characteristics of pain Analgesic treatments already received and respective efficacy Expectation for diagnostic tests (confirmation/exclusion of diagnosis, …) Expectation for TMS performed for therapeutic purposes (partial/complete recovery, motor/pain symptoms, …)
- Phase 2 (10 minutes after diagnostic explorations and therapeutic TMS): Quantification of pain generated by TMS Quantification of discomfort generated by TMS Change in pain symptoms after TMS Change in motor, sensory or cognitive symptoms after TMS Other side effects of TMS
- Phase 3 (two weeks after TMS, by telephone): Quantitative assessment of pain Brief Pain inventory Quantification of pain generated by TMS Quantification of discomfort generated by TMS Change in pain symptoms after TMS Change in motor, sensory or cognitive symptoms after TMS Other side effects of TMS
102 studies on the registry are indexed under Conversion Disorder; 36 are open to participants now.
This study's planned enrollment of 30 is below the median of 60 across 42 observational studies indexed under Conversion Disorder.
Browse Conversion Disorder studies →This is the only study on the registry with Explorations Fonctionnelles Avicenne as lead sponsor.
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Patient referred to Avicenne hospital to explore a suspected functional neurological disorder
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Exclusion Criteria:
- Lack of consent
Pain intensity experienced during TMS on a 11-point numerical rating scale (NRS) ranging from 0 (no pain) to 10 (worst possible pain)
Pain intensity experienced during TMS on a 11-point numerical rating scale (NRS) ranging from 0 (no pain) to 10 (worst possible pain)
Time frame: 1 hour
Qualitative and quantitative Pain Assessment
Qualitative and quantitative Pain Assessment Brief Pain inventory Pain characteristics
Time frame: 1 hour and 14 days
Symptoms post-TMS
Change in pain after TMS. Change in Motor, sensory or cognitive symptoms after TMS. Occured side effects.
Time frame: 1 hour and 14 days
Plan to share: No
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This study is status unknown, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.
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