Cette page a été traduite automatiquement et l'exactitude de la traduction n'est pas garantie. Veuillez vous référer au version anglaise pour un texte source.

Stimulation Interférentielle Transcrânienne Temporale à Domicile Supervisée à Distance sur les Symptômes Moteurs de la Maladie de Parkinson

20 septembre 2026 mis à jour par: Yu Liu, Shanghai University of Sport

Stimulation par Interférence Temporelle Transcrânienne Supervisée à Distance à Domicile sur les Symptômes Moteurs de la Maladie de Parkinson : Protocole pour un Essai Contrôlé Randomisé en Double Aveugle

The goal of this clinical trial is to learn if home-based temporal interference stimulation (TIS) works to improve motor symptoms in people with Parkinson's disease (PD). It will also learn about the safety of this treatment. The main questions it aims to answer are:

  1. Does home-based TIS improve movement problems such as slow movement, stiffness, and walking difficulty?
  2. Are the effects maintained after the treatment ends?
  3. What medical problems (adverse events) occur during treatment? Researchers will compare active TIS to a sham treatment (a look-alike procedure that does not deliver active stimulation) to see if TIS works.

Participants will:

  1. Receive active TIS or sham stimulation once a day for 4 weeks at home under remote supervision
  2. Visit the clinic at specific time points for movement assessments
  3. Complete online questionnaires about symptoms and quality of life

Aperçu de l'étude

Type d'étude

Interventionnel

Inscription (Estimé)

98

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

  • Nom: Yu Liu, Prof.
  • Numéro de téléphone: +86 21 65507351
  • E-mail: yuliu@sus.edu.cn

Sauvegarde des contacts de l'étude

Lieux d'étude

    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, Chine, 200438
        • Recrutement
        • Shanghai University of Sport
        • Contact:
      • Shanghai, Shanghai Municipality, Chine, 200438
        • Pas encore de recrutement
        • Shanghai University of Sport
        • Contact:

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

40 ans à 80 ans (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

Inclusion Criteria:

  • Diagnosis of Parkinson's disease according to established clinical criteria
  • Mild-to-moderate disease severity, defined as Hoehn and Yahr stage 1.5-3;
  • Age between 40 and 80 years;
  • Stable anti-parkinsonian medication regimen;
  • Ability to walk unaided for at least 2 minutes.

Exclusion Criteria:

  • contraindications to TIs (e.g., metal implantation, pacemakers, etc.);
  • the use of DBS;
  • significant cognitive impairment as defined by the diagnosis of Alzheimer's disease or dementia, or Montreal Cognitive Assessment (MoCA) total score<21, a recommended threshold for dementia in PD;
  • diagnosis of other neurological conditions such as multiple sclerosis, previous stroke;
  • report of severe lower-extremity arthritis, pain, or orthopedic problems significantly affecting gait;
  • physician-diagnosis of schizophrenia or other psychiatric illness;
  • an unwillingness to cooperate or participate in the study protocol. Eligible and interested participants will then be enrolled and complete baseline assessments before the randomization.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Tripler

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: TIs-Group

Participants in this arm will receive active transcranial temporal interference stimulation targeting the internal globus pallidus over a four-week intervention period.

Transcranial temporal interference stimulation (TIS) is a noninvasive brain stimulation technique that delivers two high-frequency alternating currents through scalp electrodes to generate a low-frequency interference field in deep brain regions. In this study, TIS targets the internal globus pallidus (GPi) to modulate neural activity in people with Parkinson's disease. Participants will receive one stimulation session per day, seven days per week, for four weeks in a home-based setting under real-time remote supervision.

The electrode placement is based on a standard 10-10 electroencephalography (EEG) system. For stimulation targeting the right GPi, electrode pairs will be positioned at CP3-CP6 and F3-F6; for stimulation targeting the left GPi, electrode pairs will be positioned at CP4-CP5 and F4-F5.

The sham TIS condition uses the same setup and procedures but does not deliver effective stimulation, thereby maintaining blinding.

Comparateur factice: Sham-TIs Group

Participants in this arm will receive sham transcranial temporal interference stimulation using the same electrode placement and experimental setup as the active intervention. The sham procedure consists of 28 sessions delivered over a four-week period, without therapeutic stimulation.

Transcranial temporal interference stimulation (TIS) is a noninvasive brain stimulation technique that delivers two high-frequency alternating currents through scalp electrodes to generate a low-frequency interference field in deep brain regions. In this study, TIS targets the internal globus pallidus (GPi) to modulate neural activity in people with Parkinson's disease. Participants will receive one stimulation session per day, seven days per week, for four weeks in a home-based setting under real-time remote supervision.

The electrode placement is based on a standard 10-10 electroencephalography (EEG) system. For stimulation targeting the right GPi, electrode pairs will be positioned at CP3-CP6 and F3-F6; for stimulation targeting the left GPi, electrode pairs will be positioned at CP4-CP5 and F4-F5.

The sham TIS condition uses the same setup and procedures but does not deliver effective stimulation, thereby maintaining blinding.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Movement Disorder Society-Unified Parkinson's Disease Rating Scale-III (MDS-UPDRS III)
Délai: Baseline, immediately after 1 and 4 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention

Change in motor symptoms assessed using the Movement Disorder Society-Unified Parkinson's Disease Rating Scale-III (MDS-UPDRS III). The total score ranges from 0 to 132, with higher scores indicating more severe motor impairment (worse outcome).

Baseline, immediately after 1 and 4 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention
The time to complete 3-meter instrumented Timed Up and Go (iTUG) test
Délai: Baseline, immediately after 1 and 4 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention

Participants will wear six wearable sensors of Mobility Lab system (Clario, Philadelphia, PA) to measure the kinematic data when performing iTUG test. In each trial, participants will be asked to stand up from a chair, walk straightforward for 3 meters, make a 180-degree turn, walk back straightly to the chair and sit down.

Baseline, immediately after 1 and 4 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
The time to complete sit-to-stand and stand-to-sit transitions in 3m-iTUG
Délai: Baseline, immediately after 1 and 4 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention.

Time (in seconds) required to stand up from a seated position and return to sitting during the 3m-iTUG test, in which participants stand up from a chair, walk 3 meters, perform a 180-degree turn, walk back, and sit down. Lower values indicate better performance.

Baseline, immediately after 1 and 4 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention.
Turning time during 3m-iTUG
Délai: Baseline, immediately after 1 and 4 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention

Time (in seconds) required to complete the 180-degree turn during the 3m-iTUG test, which includes standing up from a seated position, walking 3 meters, turning, walking back, and sitting down. Lower values indicate better performance.

Baseline, immediately after 1 and 4 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention
Response rate of MDS-UPDRS-III and gait speed
Délai: Baseline, immediately after 1 and 4 weeks of intervention

The number of participants who had a clinically meaningful improvement after the stimulation within each group. Clinically meaningful improvement will be defined as a reduction of ≥ 5 points in the MDS-UPDRS-III total score. For gait outcomes, an increase in gait speed of ≥ 0.10 m/s or ≥ 10% improvement from baseline will be considered meaningful

Baseline, immediately after 1 and 4 weeks of intervention
MDS-UPDRS-III sub scores
Délai: Baseline, immediately after 1 and 4 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention

Absolute change from baseline in four prespecified MDS-UPDRS-III sub scores in medication- "ON" and- "OFF" states, including rigidity, bradykinesia, tremor, and axial symptoms, with higher scores indicating more severe motor impairment (worse outcome).

Baseline, immediately after 1 and 4 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention
Geriatric Anxiety Inventory (GAI)
Délai: Baseline, after 2 weeks and 4 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention

A 20-item self-report scale (range: 0-20), with higher scores indicating greater anxiety severity; scores ≥8-10 suggest clinically relevant anxiety.

Baseline, after 2 weeks and 4 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention
Geriatric Depression Scale (GDS)
Délai: Baseline, after 2 weeks and 4 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention

A 15-item self-report scale (range: 0-15), with higher scores indicating greater depressive symptom severity; categorized as normal (0-4), mild (5-8), moderate (9-11), and severe (12-15).

Baseline, after 2 weeks and 4 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention
Scales for Outcomes in Parkinson's Disease-Autonomic (SCOPA-AUT)
Délai: Baseline, after 2 weeks and 4 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention

a 25-item self-report scale assessing autonomic dysfunction in Parkinson's disease (range: 0-69), with higher scores indicating more severe autonomic symptoms.

Baseline, after 2 weeks and 4 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention
Montreal Cognitive Assessment (MOCA)
Délai: Baseline, after 4 weeks of intervention

a 30-point screening tool (range: 0-30), with lower scores indicating worse global cognitive function.

Baseline, after 4 weeks of intervention
Trail Making Test (Part A/B)
Délai: Baseline, after 4 weeks of intervention

The Trail Making Test assesses processing speed (Part A) and executive function (Part B), with longer completion times indicating poorer cognitive performance.

Baseline, after 4 weeks of intervention
The Digit Span Test evaluates (DST)
Délai: Baseline, after 4 weeks of intervention

The Digit Span Test evaluates (DST) attention and working memory, with higher scores indicating better cognitive performance.

Baseline, after 4 weeks of intervention
Parkinson's Disease Sleep Scale-2 (PDSS-II)
Délai: Baseline, after 2 weeks and 4 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention

a 15-item scale (range: 0-60), with higher scores indicating more severe sleep disturbances.

Baseline, after 2 weeks and 4 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention
Epworth Sleeping Scale (ESS)
Délai: Baseline, after 2 weeks and 4 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention

an 8-item scale (range: 0-24), with higher scores indicating greater daytime sleepiness; scores ≥10 suggest excessive daytime sleepiness.

Baseline, after 2 weeks and 4 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention
Parkinson's Disease Questionnaire-39 (PDQ-39)
Délai: Baseline, after 2 weeks and 4 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention

a 39-item questionnaire (range: 0-100, scaled), with higher scores indicating poorer quality of life.

Baseline, after 2 weeks and 4 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention
Home Diary Assessment of Motor States
Délai: Baseline, immediately after 1, 2, 3, 4 weeks of intervention

Participants will record daily information including perceived medication- "ON" and- "OFF" periods [ref], time to medication onset, daily physical activity, sleep duration, and the occurrence of any adverse events.

Baseline, immediately after 1, 2, 3, 4 weeks of intervention
Safety related outcomes
Délai: After each intervention session (28 sessions over 4 weeks).
  1. Adverse events: The incidence and severity of adverse events recorded throughout the intervention and follow-up period, with higher frequency and severity indicating lower safety.
  2. Attrition rate: The proportion of participants who withdraw before completing the intervention, with higher attrition indicating lower tolerability and acceptability.
  3. Adherence rate: The proportion of completed stimulation sessions relative to the total prescribed sessions, with higher adherence indicating better feasibility and tolerability.
After each intervention session (28 sessions over 4 weeks).

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

4 avril 2026

Achèvement primaire (Estimé)

30 janvier 2028

Achèvement de l'étude (Estimé)

30 mars 2028

Dates d'inscription aux études

Première soumission

30 mars 2026

Première soumission répondant aux critères de contrôle qualité

4 avril 2026

Première publication (Réel)

8 avril 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

22 septembre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

20 septembre 2026

Dernière vérification

1 septembre 2026

Plus d'information

Termes liés à cette étude

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

S'abonner