Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06149728
Other study ID # CLEA-2023-n°338
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


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
See also
  Status Clinical Trial Phase
Recruiting NCT04310670 - Integrated Treatment in FND (Functional Neurological Disorders) N/A
Not yet recruiting NCT06346873 - Demonstrating Efficacy of JOGO for the Treatment of Tremor N/A
Active, not recruiting NCT05941702 - Body Signal Integration Training: A Case Series N/A
Recruiting NCT06084325 - The Role of Oxytocin and Interoception in Functional Neurological Disorder
Active, not recruiting NCT05581810 - Rehabilitation for Functional Memory Symptoms After Concussion N/A
Completed NCT03325374 - BLB Study Back or Leg Pain and Bladder Symptoms Study
Terminated NCT02764476 - Embodied Virtual Reality Therapy for Functional Neurological Symptom/ Conversion Disorder N/A
Not yet recruiting NCT06362161 - Establishment of an Interdisciplinary Functional Neurological Disorder (FND) Treatment Program and Development of a Clinical Care Pathway for FND
Active, not recruiting NCT03857347 - Psychoeducation Group Intervention for FND N/A
Terminated NCT03731078 - Pilot Study of Cognitive Behavioral Therapy-Informed Physical Therapy Intervention in Functional Neurological Disorders
Not yet recruiting NCT05731648 - Role of Functional Neurosurgery in Management of Spasticity
Not yet recruiting NCT06422819 - Clinical Evaluation of HRV Biofeedback in Functional Neurological Disorders Compared to Placebo N/A
Completed NCT05634486 - Efficacy of the Multidisciplinary Treatment to the Quality of Life of With Functional Movement Disorders N/A
Not yet recruiting NCT05723276 - Psilocybin in Functional Neurological Disorder N/A
Recruiting NCT06257069 - Tremor Retrainer Software Application for Functional Tremor N/A
Completed NCT04942600 - Behavioural and Electrophysiological Effects of rTMS in Functional Neurological Disorders N/A
Recruiting NCT06105996 - ADIE-FS - Aligning Dimensions of Interoceptive Experience in Patients With Functional Seizures N/A