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NCT Number: NCT07527403

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

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.

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Key information

Conditions

Functional Neurological Disorder Conversion Disorder Mental Disorders Motor FND Somatoform Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre Hospitalier Guillaume Régnier

Rennes, 35000, France

Location status: Recruiting

Location contact

Nathalie ALLETON

CONTACT

[email protected]

+332 22 51 41 21 ext. +33

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

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

Treatment and study plan

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.

Primary outcomes

  1. 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

    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.

Secondary outcomes

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

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

    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.

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

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

    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.

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

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

    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.

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

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

    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.

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

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

    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.

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

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

    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.

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

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

    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.

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

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

    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.

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

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

    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.

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

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

    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.

  11. Evaluation of the side effects of rTMS

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

    Calculation of the percentage of patients experiencing side effects

Study contacts

Contact information is provided by the study sponsor or research team.

Dominique DRAPIER, PHD

CONTACT

[email protected]

+332 99 33 39 37 ext. +33

Sponsors and collaborators

Lead sponsor

Hospital Center Guillaume Régnier

Other

Registry information

Acronym: Thêta-mTNF

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Apr 14, 2026
Registry last updated
Apr 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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