AzTrials
AzTrials

Functional Neurological DisorderThêta-mTNFNCT07527403

Impact of Theta Burst Repetitive Transcranial Magnetic Stimulation on the Patient's Self-reported Improvement in Their Motor Functional Neurological Disorder

An observational study of Functional Neurological Disorder and Motor FND, run by Hospital Center Guillaume Régnier at 1 site in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Functional Neurological Disorder, Motor FND
What is being tested?
theta-burst rTMS (repetitive transcranial magnetic stimulation)
How many people
22 participants
Where
1 siteFrance
Study dates
13 Mar 2026to Mar 2028
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Dominique DRAPIER, PHD contact

+332 99 33 39 37 ext. +33

d.drapier@ch-guillaumeregnier.fr

France1 site, 1 recruiting

  • Centre Hospitalier Guillaume Régnier

    Rennes, 35000

    Nathalie ALLETON, +332 22 51 41 21 ext. +33, driri@ch-guillaumeregnier.fr

    Recruiting

Other trials in France

About this study

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.

Read the detailed description

Functional neurological disorder (FND) is a condition that causes significant suffering and disability, as well as considerable cost to society. 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. Motor FNDs, i.e., those with motor neurological symptoms, are the best defined. In recent years, much progress has been made in terms of recognition, diagnosis, and medical care. However, in terms of treatment, the options remain limited.

Repetitive transcranial magnetic stimulation (rTMS) is a non-invasive and acceptable treatment that has proven effective in certain chronic pain conditions, depression, and OCD. It involves applying repeated magnetic pulses to a specific area of the brain in order to modify the electrical current in the concerned area and the connectivity of associated regions. Several studies have shown the effectiveness of this therapy in patients with FND, although discrepancies remain, particularly in the neuroanatomical target and evaluation criteria.

Recent advances in neuroimaging of FNDs have led to a better understanding of the pathophysiology of FNDs and have resulted in certain recommendations for the clinical evaluation of FNDs in research. The most widely shared theoretical model of motor FNDs is that of movement prediction. It suggests a predominant role for the right temporo-parietal junction (rTPJ) in FNDs.

From a neuroimaging perspective, Voon et al. demonstrated in 2010 that eight subjects with functional tremors exhibited hypoactivity in the rTPJ. This area of the brain appears to be strongly involved in the sense of agency, yet this function is impaired in subjects with FND. A study of seven patients with FND of the dissociative functional seizure type showed a reduction in the number of seizures per week following 30 sessions of rTMS targeting the rTPJ at an excitatory frequency.

More recently, S. Aybek's team demonstrated a change in brain activity in the rTPJ in a fMRI in patients with FND after a session of theta burst (tb) rTMS. Theta burst stimulation allows for more effective stimulation in a shorter time. The intermittent excitatory tb-rTMS protocol showed a tendency to increase the rTPJ activity. In this study, tolerance was evaluated as a secondary outcome measure. No adverse effects were reported other than asthenia and headaches, which are well-known and documented adverse effects of rTMS.

As part of its referral care program, the University Hospital Department of Adult Psychiatry at the Guillaume Regnier Hospital Center in Rennes receives patients suffering from FND who have been referred by their attending physicians and for whom rTMS treatment may be indicated. These patients undergo a course of 40 rTMS sessions in theta burst mode targeting the rTPJ. Taking into account the latest recommendations for the assessment of FNDs in research, the investigators wish to analyze the impact of this treatment on the overall impression of change perceived by the patient and the physician after one month (the date at which the effects of rTMS are supposed to be most apparent). Secondarily, the investigators wish to evaluate the impact of the rTMS treatment on the motor and non-motor symptoms of FNDs, such as agency, in order to better understand the pathophysiology, and also to evaluate the impact on quality of life.

Being tested
theta-burst rTMS (repetitive transcranial magnetic stimulation)
Keywords
Functional Neurological Disorder, Motor FND, Repetitive Transcranial Magnectic Stimulation (rTMS), Theta burst rTMS
Medical subject headings
Conversion Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (11)

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

    The aim is to assess the impact of rTMS on the clinician's overall impression of change (compared to the waiting period before rTMS).

    5 days before the treatment patients are assessed for all aspects of patients' health using the CGI-I. Patients take the test again on the last day of the treatment and again one month after the end of the treatment. Score ranges from 1 to 7. The lower the score, the better the change is.

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

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

    The aim is to assess whether any clinical changes occur after rTMS (compared to the waiting period before rTMS). During the 1st medical consultation for appeal patients are assessed for all aspects of patients' health using the CGI-S. Then patients retake the test 5 days before the treatment. Finally patients take the test again one month after the end of treatment. Score ranges from 1 to 7. The lower the score, the less ill the patient is.

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

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

    The aim is to assess whether any clinical changes occur after rTMS (compared to the waiting period before rTMS). During the 1st medical consultation for appeal patients are assessed using S-FMDRS. Then patients retake the test 5 days before the treatment. Finally patients take the test again one month after the end of treatment.

    It assesses the significance of Functional neurological disorder (FND) clinical symptoms in terms of severity and frequency.

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

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

    The aim is to assess whether any clinical changes occur after rTMS (compared to the waiting period before rTMS). During the 1st medical consultation for appeal patients are assessed for mood using the MADRS. Then patients retake the test 5 days before the treatment. Finally patients take the test again one month after the end of treatment.

    Score ranges from 0 to 60. The higher the score, the more severe the disorder is.

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

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

    The aim is to assess whether any clinical changes occur after rTMS (compared to the waiting period before rTMS). During the 1st medical consultation for appeal patients are assessed for fatigue using the FSS. Then patients retake the test 5 days before the treatment. Finally patients take the test again one month after the end of treatment.

    The lower the score the less likely the patient is to have excessive fatigue.

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

  6. Difference in the Dissociative Experience Scale score before versus after treatment.

    The aim is to assess the impact of rTMS on dissociation. 5 days before the treatment patients are assessed for dissociation using the DES. Patients take the test again one month after the end of treatment. Score rangers from 1 to 100. The lower the score the likely the patient is to have a dissociative disorder.

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

  7. Difference in Hospital Anxiety and Depression (HAD) score before versus after treatment.

    The aim is to assess the impact of rTMS on anxiety. 5 days before the treatment patients are assessed for anxiety and depression using the HAD scale. Patients take the test again one month after the end of treatment. The scale includes 14 items ranged from 0 to 3. Seven questions relate to anxiety (total A) and seven others to the depressive dimension (total D), thereby giving two scores (maximum score for each = 21). The lower the score the less likely the patient is to have anxiety and depression disorders.

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

  8. Difference in the French version of the Sense of Agency Scale (F-SoAS) score before versus after treatment.

    The aim is to assess the impact of rTMS on agency. 5 days before the treatment patients are assessed for their capacity to claim authorship over an action using the F-SoAS.The scale includes 7 items ranged from1 to 7. Score ranges from 7 to 49.The higher the score, the greater the person's sense of control over their actions. Patients take the test again one month after the end of treatment.

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

  9. Difference in the 36-Item Short Form Health Survey (SF-36) score before versus after treatment.

    The aim is to assess the impact of rTMS on quality of life. 5 days before the treatment patients are assessed for their quality of life using the SF-36. Patients take the test again one month after the end of treatment. Score ranges from 0 to 100. The higher the score the more favorable health state for the patient.

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

  10. Difference in PGIC (Patients' global impressions of change) score throughout the treatment process.

    The aim is to assess the kinetics of changes in the patient's overall perception of change. The patients are assessed for all aspects of patients' health using the PGIC score thoughout the process: 5 days before the start of the treatment, at the end of the last rTMS treatment, 15 days after the last rTMS and one month after the last rTMS tratment. Score ranges from 1 to 7, the smaller the score, the better the change is.

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

  11. Evaluation of the side effects of rTMS

    Calculation of the percentage of patients experiencing side effects

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Apr 2026
  2. Study start13 Mar 2026
  3. Primary completionMar 2028 (estimated)
  4. Study completionMar 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
22 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07527403
Sponsor's protocol ID
RNI25_01_DD
Other IDs
2025-A02101-48
Acronym
Thêta-mTNF
Status last verified
Jan 2026
First submitted
7 Apr 2026
Last updated
20 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Data about study protocol and clinical information will be available on request from other researchers.

Publications

  • Pick S, Anderson DG, Asadi-Pooya AA, Aybek S, Baslet G, Bloem BR, Bradley-Westguard A, Brown RJ, Carson AJ, Chalder T, Damianova M, David AS, Edwards MJ, Epstein SA, Espay AJ, Garcin B, Goldstein LH, Hallett M, Jankovic J, Joyce EM, Kanaan RA, Keynejad RC, Kozlowska K, LaFaver K, LaFrance WC Jr, Lang AE, Lehn A, Lidstone S, Maurer CW, Mildon B, Morgante F, Myers L, Nicholson C, Nielsen G, Perez DL, Popkirov S, Reuber M, Rommelfanger KS, Schwingenshuh P, Serranova T, Shotbolt P, Stebbins GT, Stone J, Tijssen MA, Tinazzi M, Nicholson TR. Outcome measurement in functional neurological disorder: a systematic review and recommendations. J Neurol Neurosurg Psychiatry. 2020 Jun;91(6):638-649. doi: 10.1136/jnnp-2019-322180. Epub 2020 Feb 28.

    PubMed 32111637

  • Buhler 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. 2024 Feb 14;6(1):e000525. doi: 10.1136/bmjno-2023-000525. eCollection 2024.

    PubMed 38361967

  • 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. 2018 Nov;59(6):601-606. doi: 10.1016/j.psym.2018.03.001. Epub 2018 Mar 7.

    PubMed 29628295

  • Zito GA, Wiest R, Aybek S. Neural correlates of sense of agency in motor control: A neuroimaging meta-analysis. PLoS One. 2020 Jun 5;15(6):e0234321. doi: 10.1371/journal.pone.0234321. eCollection 2020.

    PubMed 32502189

  • Voon V, Gallea C, Hattori N, Bruno M, Ekanayake V, Hallett M. The involuntary nature of conversion disorder. Neurology. 2010 Jan 19;74(3):223-8. doi: 10.1212/WNL.0b013e3181ca00e9.

    PubMed 20083798

  • Hallett M, Aybek S, Dworetzky BA, McWhirter L, Staab JP, Stone J. Functional neurological disorder: new subtypes and shared mechanisms. Lancet Neurol. 2022 Jun;21(6):537-550. doi: 10.1016/S1474-4422(21)00422-1. Epub 2022 Apr 14.

    PubMed 35430029

  • Gonsalvez I, Spagnolo P, Dworetzky B, Baslet G. Neurostimulation for the treatment of functional neurological disorder: A systematic review. Epilepsy Behav Rep. 2021 Nov 9;16:100501. doi: 10.1016/j.ebr.2021.100501. eCollection 2021.

    PubMed 34950864

  • Marder KG, Barbour T, Ferber S, Idowu O, Itzkoff A. Psychiatric Applications of Repetitive Transcranial Magnetic Stimulation. Focus (Am Psychiatr Publ). 2022 Jan;20(1):8-18. doi: 10.1176/appi.focus.20210021. Epub 2022 Jan 25.

    PubMed 35746935

  • 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. 2021 Jan 1;78(1):88-101. doi: 10.1001/jamaneurol.2020.3753.

    PubMed 33104173

Questions about this trial

What is this clinical trial studying?

An observational study of Functional Neurological Disorder and Motor FND, run by Hospital Center Guillaume Régnier at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 20 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Dominique DRAPIER, PHD (+332 99 33 39 37 ext. +33, d.drapier@ch-guillaumeregnier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Difference in PGIC (Patient Global Impression of Change) score before versus after treatment. (time frame: From enrollment to the end of the data collecting process : 1 month and 3 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07527403, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in