NCT06149728

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 15, 2023

Completed
Same day until next milestone

Study Start

First participant enrolled

November 15, 2023

Completed
14 days until next milestone

First Posted

Study publicly available on registry

November 29, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2024

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2024

Completed
Last Updated

December 12, 2023

Status Verified

December 1, 2023

Enrollment Period

5 months

First QC Date

November 15, 2023

Last Update Submit

December 5, 2023

Conditions

Functional Neurological Disorder

Keywords

Functional Neurological DisorderPainTMS

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Qualitative and quantitative Pain Assessment

    1 hour and 14 days

  • Symptoms post-TMS

    1 hour and 14 days

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Patient referred to Avicenne hospital to explore a suspected functional neurological disorder
  • Patient able to complete the questionnaire

You may not qualify if:

  • \- Lack of consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

HUPSSD

Bobigny, 93000, France

RECRUITING

MeSH Terms

Conditions

Conversion DisorderPain

Condition Hierarchy (Ancestors)

Somatoform DisordersMental DisordersNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
NETWORK
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD PhD

Study Record Dates

First Submitted

November 15, 2023

First Posted

November 29, 2023

Study Start

November 15, 2023

Primary Completion

April 1, 2024

Study Completion

November 1, 2024

Last Updated

December 12, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)