NCT07527403

Brief Summary

Functional neurological disorder (FND) is a condition that causes significant suffering and disability. It is defined by the presence of neurological symptoms that interfere with an individual's functioning and are not consistent with any known anatomical lesion but that causes significant functional impairment. The investigators are particularly interested in motor symptoms (abnormal movements or motor deficits). Repetitive transcranial magnetic stimulation (rTMS) is a non-invasive and acceptable treatment that has proven effective in certain chronic pain conditions, depression, and OCD. The investigators would like to evaluate the impact of rTMS on the patient's overall perception of change, particularly on the clinical symptoms of motor FND. Secondary objectives include evaluating the overall effect on symptoms from the clinician's perspective, the effect on quality of life, on depressive and anxiety symptoms and associated dissociation, as well as evaluating any changes in the sense of agency and identifying the side effects of rTMS treatment.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
22

participants targeted

Target at below P25 for all trials

Timeline
22mo left

Started Mar 2026

Geographic Reach
1 country

1 active site

Status
recruiting

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

Study Progress8%
Mar 2026Mar 2028

Study Start

First participant enrolled

March 13, 2026

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

April 7, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 14, 2026

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2028

Last Updated

April 20, 2026

Status Verified

January 1, 2026

Enrollment Period

2 years

First QC Date

April 7, 2026

Last Update Submit

April 15, 2026

Conditions

Functional Neurological DisorderMotor FND

Keywords

Functional Neurological DisorderMotor FNDRepetitive Transcranial Magnectic Stimulation (rTMS)Theta burst rTMS

Outcome Measures

Primary Outcomes (1)

  • Difference in PGIC (Patient Global Impression of Change) score before versus after treatment.

    The aim is to measure the impact of a course of thetaburst rTMS targeting the rTPJ on the patient's overall impression of change. 5 days before the treatment patients are assessed for all aspects of patients' health using the PGIC. Patients take the test again on the last day of the treatment and again one month after the end of treatment. Score ranges from 1 to 7, the bigger the score, the better the change is.

    From enrollment to the end of the data collecting process : 1 month and 3 weeks

Secondary Outcomes (11)

  • Difference in CGI-I (Clinical Global Impressions - Improvement) score before versus after treatment

    From enrollment to end of data collecting : 1 month and 3 weeks

  • Difference in CGI-Severity (CGI-S) score before versus after treatment.

    From enrollment to the end of the data collecting process : about three months

  • Difference in Simplified-functional movement disorder rating scale (S-FMDRS) score before versus after treatment

    From enrollment to the end of the data collecting process : about three months

  • Difference in MADRS (Montgomery-Asberg Depression Rating Scale) score before versus after treatment

    From enrollment to the end of the data collecting process : about three months

  • Difference in Fatigue Severity Scale (FSS) score before versus after treatment

    From enrollment to the end of the data collecting process : about three months

  • +6 more secondary outcomes

Interventions

theta-burst rTMS (repetitive transcranial magnetic stimulation)OTHER

Patients receive 40 sessions of intermittent theta burst stimulation of the right TPJ over 10 days (4 sessions per day). The right TPJ is located using neuronavigation.

Eligibility Criteria

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

Patients with Functional Neurological Disorder who have been referred by neurologist to have rTMS.

You may qualify if:

  • Patients over 18
  • Patients with FND, either deficits or abnormal movements, diagnosed by a neurologist.
  • Patients with an indication for validated neuronavigated rTMS treatment.
  • Patients who have indicated that they do not object to participating in the study.

You may not qualify if:

  • Patients subject to legal protection (legal guardianship, conservatorship, trusteeship)
  • Patients deprived of liberty

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier Guillaume Régnier

Rennes, 35000, France

RECRUITING

Related Publications (9)

  • Pick S, Anderson DG, Asadi-Pooya AA, Aybek S, Baslet G, Bloem BR, et al. Outcome measurement in functional neurological disorder: a systematic review and recommendations. J Neurol Neurosurg Psychiatry. juin 2020;91(6):638-49

    BACKGROUND

  • Bühler J, Weber S, Loukas S, Walther S, Aybek S. Non-invasive neuromodulation of the right temporoparietal junction using theta-burst stimulation in functional neurological disorder. BMJ Neurol Open. 14 févr 2024;6(1):e000525

    BACKGROUND

  • Peterson KT, Kosior R, Meek BP, Ng M, Perez DL, Modirrousta M. Right Temporoparietal Junction Transcranial Magnetic Stimulation in the Treatment of Psychogenic Nonepileptic Seizures: A Case Series. Psychosomatics. 1 nov 2018;59(6):601-6

    BACKGROUND

  • Zito GA, Wiest R, Aybek S. Neural correlates of sense of agency in motor control: A neuroimaging meta-analysis. PLoS One. 5 juin 2020;15(6):e0234321

    BACKGROUND

  • Voon V, Gallea C, Hattori N, Bruno M, Ekanayake V, Hallett M. The involuntary nature of conversion disorder. Neurology. 19 janv 2010;74(3):223-8

    BACKGROUND

  • Hallett M, Aybek S, Dworetzky BA, McWhirter L, Staab JP, Stone J. Functional neurological disorder: new subtypes and shared mechanisms. Lancet Neurol. juin 2022;21(6):537-50

    BACKGROUND

  • Gonsalvez I, Spagnolo P, Dworetzky B, Baslet G. Neurostimulation for the treatment of functional neurological disorder: A systematic review. Epilepsy & Behavior Reports. 1 janv 2021;16:100501

    BACKGROUND

  • Marder KG, Barbour T, Ferber S, Idowu O, Itzkoff A. Psychiatric Applications of Repetitive Transcranial Magnetic Stimulation. Focus (Am Psychiatr Publ). janv 2022;20(1):8-18.

    BACKGROUND

  • Stephen CD, Fung V, Lungu CI, Espay AJ. Assessment of Emergency Department and Inpatient Use and Costs in Adult and Pediatric Functional Neurological Disorders. JAMA Neurol. 1 janv 2021;78(1):88-101.

    BACKGROUND

MeSH Terms

Conditions

Conversion Disorder

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Somatoform DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Magnetic Field TherapyTherapeutics

Central Study Contacts

Dominique DRAPIER, PHD

CONTACT

+332 99 33 39 37d.drapier@ch-guillaumeregnier.fr

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 7, 2026

First Posted

April 14, 2026

Study Start

March 13, 2026

Primary Completion (Estimated)

March 1, 2028

Study Completion (Estimated)

March 1, 2028

Last Updated

April 20, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Data about study protocol and clinical information will be available on request from other researchers.

Locations

FR(1)