Pain Assessment and Transcranial Magnetic Stimulation Tolerability in Patients With a Functional Neurological Disorder

Functional Neurological Disorder Clinical Trial

Official title:

Pain Assessment and Transcranial Magnetic Stimulation Tolerability in Patients With a Functional Neurological Disorder

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06149728
• Other study ID #: CLEA-2023-n°338
• Status: Recruiting
• Start date: November 15, 2023
• Est. completion date: November 2024

Study information

• Verified date: December 2023
• Source: Explorations Fonctionnelles Avicenne
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: November 2024
• Est. primary completion date: April 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patient referred to Avicenne hospital to explore a suspected functional neurological disorder

• Patient able to complete the questionnaire

Exclusion Criteria:

• Lack of consent

Related Conditions & MeSH terms

• Conversion Disorder
• Functional Neurological Disorder
• Nervous System Diseases

Locations

Country	Name	City	State
France	HUPSSD	Bobigny

Sponsors (1)

Lead Sponsor	Collaborator
Explorations Fonctionnelles Avicenne

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	1 hour
Secondary	Qualitative and quantitative Pain Assessment	Qualitative and quantitative Pain Assessment Brief Pain inventory Pain characteristics	1 hour and 14 days
Secondary	Symptoms post-TMS	Change in pain after TMS. Change in Motor, sensory or cognitive symptoms after TMS. Occured side effects.	1 hour and 14 days