Temporal Interference Stimulation for Motor and Non-motor Symptoms in Parkinson's Disease
A Prospective Observational Cohort Study of Temporal Interference Stimulation Treatment for Improving Motor and Non-motor Symptoms in Patients With Parkinson's Disease
This study aims to evaluate the efficacy of tTIS treatment in improving motor function in patients with Parkinson's disease (PD), as well as its effects on mood, activities of daily living, sleep, cognition, and other functional domains. It also seeks to assess differences in treatment response among PD subtypes (tremor-dominant, rigidity-dominant, and mixed) and across disease stages (early stage, Hoehn and Yahr [H&Y] stages 1-2, and mid-to-late stage, H&Y stages 2.5-3). The study will enroll eligible PD patients and evaluate their condition using the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS), the 39-item Parkinson's Disease Questionnaire (PDQ-39), the Pittsburgh Sleep Quality Index (PSQI), the Hamilton Anxiety Rating Scale (HAMA), the Hamilton Depression Rating Scale (HAMD), and a visual analog scale (VAS) for fatigue. Assessments will be performed before routine tTIS treatment, immediately after treatment, and at two and four weeks post-treatment, in order to analyze the therapeutic effect of tTIS in PD. This is an observational study without any intervention; all enrolled participants will receive standard medical care and health education.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Studientyp
Einschreibung (Geschätzt)
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Probenahmeverfahren
Studienpopulation
Patients with a confirmed diagnosis of Parkinson's disease who are scheduled to undergo routine tTIS treatment and fulfill the study's inclusion and exclusion criteria.
Beschreibung
Inclusion Criteria:
- Age ≥18 years, any gender.
- Diagnosis of idiopathic Parkinson's disease according to the Movement Disorder Society (MDS) clinical diagnostic criteria: the patient must (a) exhibit parkinsonism (bradykinesia plus rest tremor and/or rigidity); (b) not meet any of the MDS absolute exclusion criteria; and (c) have at least two MDS supportive criteria.
- Disease duration ≥1 year, with stable clinical status.
- Hoehn and Yahr stage 1.5-3; on a stable dose of levodopa or other dopaminergic medications, with a documented response to levodopa; treatment regimen remains unchanged throughout the study period.
- The patient is scheduled to receive tTIS treatment.
- The subject or legally authorized representative is able to provide written informed consent.
Exclusion Criteria:
- Severe cognitive impairment, defined as a Mini-Mental State Examination (MMSE) score ≤17 for illiterate individuals, ≤20 for those with primary school education, and ≤24 for those with junior high school education or above; poor compliance due to dementia and/or inability to provide informed consent.
- History of severe psychiatric disorder, or a Hamilton Depression Rating Scale (HAMD) score >24.
- History of use of antipsychotics, antidepressants, or other medications that may affect dopamine levels.
- History of seizures within the past 1 year, or a family history of epilepsy.
- Inability to complete follow-up visits as required during the study.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Beobachtungsmodelle: COHORT
- Zeitperspektiven: PROSPECTIVE
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Change in Score on Part III (Motor Examination) of the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
Zeitfenster: at baseline(before treatment), immediately after the patient receives tTIS treatment, and and at the two-week and four-week follow-ups after the completion of treatment.
|
The motor function of patients was assessed using Part III of the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS-III), which has a total score range of 0 to 132. In this scale, a higher score indicates greater severity of motor symptoms and therefore a worse outcome, with 0 representing no impairment and 132 representing the most severe impairment. Changes in the score reflect the degree of improvement in motor function. |
at baseline(before treatment), immediately after the patient receives tTIS treatment, and and at the two-week and four-week follow-ups after the completion of treatment.
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
MDS-UPDRS Scale Part I Non-Motor Function Score Changes
Zeitfenster: at baseline(before treatment), immediately after the patient receives tTIS treatment, and at the two-week and four-week follow-ups after the completion of treatment.
|
The MDS-UPDRS Scale Part I Non-Motor Function score was used to assess the patient's Cognitive impairment, hallucinations and psychiatric symptoms, depression, apathy, impulse control disorders/dopamine dysregulation syndrome, sleep disorders, pain and other sensory symptoms, and urinary symptoms, with changes in the score reflecting the degree of improvement in those functions. The score for Part I ranges from 0 to 52 points. A higher score indicates greater impairment or more severe non-motor symptoms. |
at baseline(before treatment), immediately after the patient receives tTIS treatment, and at the two-week and four-week follow-ups after the completion of treatment.
|
|
MDS-UPDRS Scale Part II: Activities of Daily Living Score Changes
Zeitfenster: at baseline(before treatment), immediately after the patient receives tTIS treatment, and at the two-week and four-week follow-ups after the completion of treatment.
|
The MDS-UPDRS Scale Part II score was used to assess the patient's Activities of Daily Living, with changes in the score reflecting the degree of improvement in daily functions. The score for Part II ranges from 0 to 52 points. A higher score indicates greater impairment in daily activities. |
at baseline(before treatment), immediately after the patient receives tTIS treatment, and at the two-week and four-week follow-ups after the completion of treatment.
|
|
MDS-UPDRS Scale Part IV: Motor Fluctuations, Dyskinesias, and Dystonia Score Changes
Zeitfenster: at baseline(before treatment), immediately after the patient receives tTIS treatment, and at the two-week and four-week follow-ups after the completion of treatment.
|
The MDS-UPDRS Scale Part IV score was used to assess the patient's Motor Fluctuations, Dyskinesias, and Dystonia. The score for Part IV ranges from 0 to 24 points. A higher score indicates more severe motor complications caused by long-term levodopa therapy. |
at baseline(before treatment), immediately after the patient receives tTIS treatment, and at the two-week and four-week follow-ups after the completion of treatment.
|
|
Change in Score on the 39-item Parkinson's Disease Questionnaire (PDQ-39)
Zeitfenster: at baseline(before treatment), immediately after the patient receives tTIS treatment, and at the two-week and four-week follow-ups after the completion of treatment.
|
The 39-item Parkinson's Disease Questionnaire (PDQ-39) is used to assess the disease-specific health-related quality of life in patients with Parkinson's disease. The summary index score ranges from 0 to 100 points. A higher score indicates a poorer quality of life. |
at baseline(before treatment), immediately after the patient receives tTIS treatment, and at the two-week and four-week follow-ups after the completion of treatment.
|
|
Change in Score on the Hamilton Depression Rating Scale (HAMD)
Zeitfenster: at baseline(before treatment), immediately after the patient receives tTIS treatment, and at the two-week and four-week follow-ups after the completion of treatment.
|
Change in Score on the Hamilton Depression Rating Scale (HAMD) is used to evaluate the severity of depressive symptoms. This assessment consists of 17 items with a total score range from 0 to 54 points; a higher score indicates a worse outcome. With common clinical thresholds (e.g., 0-7 = Normal, 8-16 = Mild Depression, 17-23 = Moderate Depression, ≥24 = Severe Depression). |
at baseline(before treatment), immediately after the patient receives tTIS treatment, and at the two-week and four-week follow-ups after the completion of treatment.
|
|
Change in Score on the Hamilton Anxiety Rating Scale (HAMA)
Zeitfenster: at baseline(before treatment), immediately after the patient receives tTIS treatment, and at the two-week and four-week follow-ups after the completion of treatment.
|
The Hamilton Anxiety Rating Scale (HAMA) is a 14-item scale to evaluate the severity of anxiety symptoms, where each item is rated on a scale from 0 to 4. The HAMA total score ranges from 0 to 56, with lower scores indicating fewer anxiety symptoms. |
at baseline(before treatment), immediately after the patient receives tTIS treatment, and at the two-week and four-week follow-ups after the completion of treatment.
|
|
Change in Score on the Pittsburgh Sleep Quality Index (PSQI)
Zeitfenster: at baseline(before treatment), immediately after the patient receives tTIS treatment, and at the two-week and four-week follow-ups after the completion of treatment.
|
the Pittsburgh Sleep Quality Index (PSQI) is used to assess sleep quality and disturbances over the past month. With changes in the score reflecting the multiple factors of daily function. Each component is scored from 0 to 3. The global PSQI score is the sum of the 7 component scores, ranging from 0 to 21 points. A higher total score indicates poorer sleep quality |
at baseline(before treatment), immediately after the patient receives tTIS treatment, and at the two-week and four-week follow-ups after the completion of treatment.
|
Mitarbeiter und Ermittler
Sponsor
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Geschätzt)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 20260597
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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 .