Меню
Идёт набор NCT07527403

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

Наблюдательное Functional Neurological Disorder Motor FND

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: theta-burst rTMS (repetitive transcranial magnetic stimulation).
Кому может быть актуально
Состояния в реестре: Functional Neurological Disorder, Motor FND. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Франция
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Обзор

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.

Подробное описание

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.

Вмешательства

  • Другое theta-burst rTMS (repetitive transcranial magnetic stimulation)
    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.

Первичные конечные точки

  • Difference in PGIC (Patient Global Impression of Change) score before versus after treatment. [Срок оценки: From enrollment to the end of the data collecting process : 1 month and 3 weeks]
Вторичные конечные точки (11)
  • Difference in CGI-I (Clinical Global Impressions - Improvement) score before versus after treatment [Срок оценки: From enrollment to end of data collecting : 1 month and 3 weeks]
  • Difference in CGI-Severity (CGI-S) score before versus after treatment. [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: From enrollment to the end of the data collecting process : about three months]
  • Difference in Fatigue Severity Scale (FSS) score before versus after treatment [Срок оценки: From enrollment to the end of the data collecting process : about three months]
  • Difference in the Dissociative Experience Scale score before versus after treatment. [Срок оценки: From enrollment to the end of the data collecting process : 1 month and 3 weeks]
  • Difference in Hospital Anxiety and Depression (HAD) score before versus after treatment. [Срок оценки: From enrollment to the end of the data collecting process : 1 month and 3 weeks]
  • Difference in the French version of the Sense of Agency Scale (F-SoAS) score before versus after treatment. [Срок оценки: From enrollment to the end of the data collecting process : 1 month and 3 weeks]
  • Difference in the 36-Item Short Form Health Survey (SF-36) score before versus after treatment. [Срок оценки: From enrollment to the end of the data collecting process : 1 month and 3 weeks]
  • Difference in PGIC (Patients' global impressions of change) score throughout the treatment process. [Срок оценки: From enrollment to the end of the data collecting process : 1 month and 3 weeks]
  • Evaluation of the side effects of rTMS [Срок оценки: From enrollment to the end of the data collecting process : 1 month and 3 weeks]

Критерии участия

Критерии включения

  • 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.

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Только случаи

Центры проведения

Франция · 1 центр
  • Centre Hospitalier Guillaume Régnier — Rennes

Публикации

  • 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 PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 35746935

Идентификаторы

NCT: NCT07527403 · RNI25_01_DD · 2025-A02101-48

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗