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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorHospital Center Guillaume Régnier

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Patients subject to legal protection (legal guardianship, conservatorship, trusteeship)

Patients deprived of liberty

Trial population

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

Trial design

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

  • theta-burst rTMS (repetitive transcranial magnetic stimulation)

    Other intervention

    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.

Treatment groups

No treatment groups listed

Trial outcomes

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.

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

Secondary outcomes

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.

Time frame
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.

Time frame
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.

Time frame
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.

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

Other outcomes

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