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Individualized Transcranial Magnetic Stimulation in Parkinsonian Disorders

29. April 2026 aktualisiert von: 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.

Studienübersicht

Status

Rekrutierung

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Geschätzt)

50

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studieren Sie die Kontaktsicherung

Studienorte

  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100034
        • Rekrutierung
        • Peking University First Hospital
        • Kontakt:
        • Unterermittler:
          • Luhua Wei, M.D.
        • Hauptermittler:
          • Zhaoxia Wang, M.D.

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: N / A
  • Interventionsmodell: Einzelgruppenzuweisung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: individualized rTMS
Gerät: 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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change in motor symptoms measured by MDS-UPDRS Part III
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change in motor symptoms measured by UMSARS Part II
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Peking University First Hospital

Mitarbeiter

Changping Laboratory

Ermittler

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

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

22. Dezember 2025

Primärer Abschluss (Geschätzt)

22. September 2027

Studienabschluss (Geschätzt)

22. Dezember 2027

Studienanmeldedaten

Zuerst eingereicht

16. April 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

29. April 2026

Zuerst gepostet (Tatsächlich)

6. Mai 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

6. Mai 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

29. April 2026

Zuletzt verifiziert

1. April 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • PKUFH-2026-TMS-001

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Beschreibung des IPD-Plans

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

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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