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Individualized Transcranial Magnetic Stimulation in Parkinsonian Disorders

29 aprile 2026 aggiornato da: Peking University First Hospital

Exploration of the Efficacy of Individualized Transcranial Magnetic Stimulation in the Treatment of Parkinsonian Disorders

This clinical trial aims to evaluate whether individualized targeted repetitive transcranial magnetic stimulation (rTMS) can improve motor and non-motor symptoms in patients with parkinsonian disorders. The main question it aims to answer is:

  • Does individualized targeted rTMS alleviate symptoms of parkinsonian disorders?
  • Which clinical manifestations of parkinsonian syndromes are responsive to individualized targeted rTMS, and to what degree?

Procedures:

  • Preparation (Screening) Participants will undergo clinical assessments, MRI, and EEG before the treatment.
  • Treatment (2 Weeks) Participants will receive a 10-day TMS treatment (once daily, Monday-Friday). Each treatment day takes approximately 3-4 hours. Participants need to keep stable medications and rehabilitation routines during this time.
  • Follow-up (10 Weeks) Participants will undergo follow-up assessments at the end of treatment and 10 weeks after treatment. Assessments include clinical scales, MRI, and EEG.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Stimato)

50

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Backup dei contatti dello studio

Luoghi di studio

  • Cina
    • Beijing Municipality
      • Beijing, Beijing Municipality, Cina, 100034
        • Reclutamento
        • Peking University First Hospital
        • Contatto:
        • Sub-investigatore:
          • Luhua Wei, M.D.
        • Investigatore principale:
          • Zhaoxia Wang, M.D.

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

Inclusion Criteria:

  1. Diagnostic Criteria Clinically established or clinically probable Parkinson's Disease (PD) according to the 2015 International Parkinson and Movement Disorder Society (MDS) diagnostic criteria; Clinically established or clinically probable Multiple System Atrophy (MSA) according to the 2022 MDS diagnostic criteria; Clinically probable or clinically possible Progressive Supranuclear Palsy (PSP) according to the 2017 MDS diagnostic criteria.
  2. Demographics Aged 30 to 80 years, inclusive; no gender restrictions.
  3. Disease Severity and Staging PD: Modified Hoehn and Yahr (H-Y) stage 2-4; MSA: Unified Multiple System Atrophy Rating Scale (UMSARS) Part IV stage 1-4; PSP: Modified Rankin Scale (mRS) grade 2-4.
  4. Informed Consent and Compliance Ability to understand and comply with the study requirements and provide written informed consent.

Exclusion Criteria:

  1. Contraindications to TMS Presence of intracranial metallic implants or other foreign bodies, including but not limited to cochlear implants, cardiac pacemakers, or internal metallic/magnetic fragments.
  2. Contraindications to EEG and MRI EEG: Known allergy to conductive paste or other EEG-related contraindications. MRI: History of claustrophobia, presence of MRI-incompatible implants, or extensive tattoos.
  3. Concurrent Physical Therapies Currently receiving Transcranial Magnetic Stimulation (TMS) or other therapeutic physical modalities, such as Transcranial Direct Current Stimulation (tDCS).
  4. Unstable Medical Conditions Presence of unstable systemic diseases requiring urgent pharmacological or surgical intervention.
  5. Neurological and Psychiatric History Personal or family history of epilepsy; History of moderate-to-severe psychiatric or psychological disorders; Chronic insomnia or regular use of sedative-hypnotics; Current use of medications that significantly alter central nervous system excitability.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: N / A
  • Modello interventistico: Assegnazione di gruppo singolo
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: individualized rTMS
Dispositivo: TMS
Intermittent theta burst stimulation (iTBS) will be delivered using a figure-of-eight coil targeting the individualized somato-cognitive action network sites (involving superior and central region) in the left hemisphere. Stimulation intensity will be set at 100% of the resting motor threshold. The iTBS protocol will consist of bursts of 3 pulses at 50 Hz, repeated at 5 Hz. Each stimulation train include 10 bursts, with an inter-train interval of 8 seconds. A total of 60 trains will be delivered, resulting in 1800 pulses per session, with four consecutive sessions and a 50-minute interval between sessions, yielding 7200 pulses per target, and a total of 14,400 pulses per day, over ten consecutive working days.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in motor symptoms measured by MDS-UPDRS Part III
Lasso di tempo: Baseline to post-treatment and 10 weeks after treatment
Motor symptoms will be assessed using the Movement Disorder Society-sponsored Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III. The total score ranges from 0 to 132, with higher scores indicating more severe motor impairment and a worse outcome. Change from baseline will be calculated at the specified follow-up visit.
Baseline to post-treatment and 10 weeks after treatment
Change in mobility measured by the 5-meter Timed Up and Go test
Lasso di tempo: Baseline to post-treatment and 10 weeks after treatment
Mobility will be assessed using the 5-meter Timed Up and Go test. The result is recorded as the time in seconds required to stand up from a chair, walk 5 meters, turn around, walk back, and sit down. The theoretical minimum value is 0 seconds, and there is no fixed maximum value. A longer time indicates poorer mobility and a worse outcome. Change from baseline will be calculated at the specified follow-up visit.
Baseline to post-treatment and 10 weeks after treatment
Change in non-motor symptoms measured by the Non-Motor Symptoms Questionnaire
Lasso di tempo: Baseline to post-treatment and 10 weeks after treatment
Non-motor symptoms will be assessed using the Non-Motor Symptoms Questionnaire. The total score ranges from 0 to 30, with higher scores indicating a greater burden of non-motor symptoms and a worse outcome. Change from baseline will be calculated at the specified follow-up visit.
Baseline to post-treatment and 10 weeks after treatment

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in motor symptoms measured by UMSARS Part II
Lasso di tempo: Baseline to post-treatment and 10 weeks after treatment
Motor impairment in patients with multiple system atrophy will be assessed using the Unified Multiple System Atrophy Rating Scale (UMSARS) Part II. The total score ranges from 0 to 56, with higher scores indicating more severe motor impairment and a worse outcome. Change from baseline will be calculated at the specified follow-up visit.
Baseline to post-treatment and 10 weeks after treatment
Change in disease severity measured by PSPRS
Lasso di tempo: Baseline to post-treatment and 10 weeks after treatment
Disease severity in patients with progressive supranuclear palsy will be assessed using the Progressive Supranuclear Palsy Rating Scale (PSPRS). The total score ranges from 0 to 100, with higher scores indicating greater disease severity and a worse outcome. Change from baseline will be calculated at the specified follow-up visit.
Baseline to post-treatment and 10 weeks after treatment
Change in balance measured by the Berg Balance Scale
Lasso di tempo: Baseline to post-treatment and 10 weeks after treatment
Balance function will be assessed using the Berg Balance Scale. The total score ranges from 0 to 56, with higher scores indicating better balance performance and a better outcome. Change from baseline will be calculated at the specified follow-up visit.
Baseline to post-treatment and 10 weeks after treatment
Change in ataxia severity measured by SARA
Lasso di tempo: Baseline to post-treatment and 10 weeks after treatment
Ataxia severity will be assessed using the Scale for the Assessment and Rating of Ataxia (SARA). The total score ranges from 0 to 40, with higher scores indicating more severe ataxia and a worse outcome. Change from baseline will be calculated at the specified follow-up visit.
Baseline to post-treatment and 10 weeks after treatment
Change in autonomic symptoms measured by the COMPASS-31
Lasso di tempo: Baseline to post-treatment and 10 weeks after treatment
Autonomic symptoms will be assessed using the Composite Autonomic Symptom Score 31 (COMPASS-31). The total weighted score ranges from 0 to 100, with higher scores indicating more severe autonomic symptoms and a worse outcome. Change from baseline will be calculated at the specified follow-up visit.
Baseline to post-treatment and 10 weeks after treatment
Change in maximal systolic blood pressure drop during active standing
Lasso di tempo: Baseline to post-treatment and 10 weeks after treatment
Orthostatic blood pressure regulation will be assessed using the maximal drop in systolic blood pressure during the active standing test. The value is measured in mmHg. There is no fixed maximum value; larger systolic blood pressure drops indicate more severe orthostatic blood pressure dysregulation and a worse outcome. Change from baseline will be calculated at the specified follow-up visit.
Baseline to post-treatment and 10 weeks after treatment
Change in post-void residual volume
Lasso di tempo: Baseline to post-treatment and 10 weeks after treatment
Urinary dysfunction will be assessed using post-void residual volume. The value is measured in milliliters. The minimum value is 0 mL, and there is no fixed maximum value. Higher post-void residual volume indicates greater urinary retention and a worse outcome. Change from baseline will be calculated at the specified follow-up visit.
Baseline to post-treatment and 10 weeks after treatment

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Peking University First Hospital

Collaboratori

Changping Laboratory

Investigatori

  • Investigatore principale: Zhaoxia Wang, M.D., Peking University First Hospital

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

22 dicembre 2025

Completamento primario (Stimato)

22 settembre 2027

Completamento dello studio (Stimato)

22 dicembre 2027

Date di iscrizione allo studio

Primo inviato

16 aprile 2026

Primo inviato che soddisfa i criteri di controllo qualità

29 aprile 2026

Primo Inserito (Effettivo)

6 maggio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

6 maggio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

29 aprile 2026

Ultimo verificato

1 aprile 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • PKUFH-2026-TMS-001

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Descrizione del piano IPD

Individual participant data will not be shared due to privacy concerns and institutional regulations.

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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