- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT07625540
Subthalamic Nucleus-Targeted Transcranial Temporal Interference Stimulation for Motor and Non-Motor Symptoms in Parkinson's Disease (STN-tTIS-PD)
2 juni 2026 uppdaterad av: Xiaoying Zhu, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Study on the Efficacy and Safety of Subthalamic Nucleus (STN)-Targeted Transcranial Temporal Interference Stimulation (tTIS) for Motor and Non-Motor Symptoms in Parkinson's Disease (PD): A Randomized, Double-Blind, Controlled Exploratory Trial
Transcranial temporal interference stimulation (tTIS) is a non-invasive deep brain stimulation method.
This study aims to comprehensively explore the efficacy and safety of bilateral subthalamic nucleus (STN) tTIS on motor and non-motor symptoms in patients with Parkinson's disease (PD).
Studieöversikt
Status
Rekrytering
Betingelser
Detaljerad beskrivning
This is a single-center, randomized, double-blind, sham-controlled trial for Parkinson's disease (PD).
The transcranial temporal interference stimulation (tTIS) intervention period is 5 days, with follow-up assessments conducted immediately after the intervention, 10 days post-intervention, and 30 days post-intervention.
The real stimulation group receives bilateral subthalamic nucleus (STN) -targeted tTIS once daily for 5 days.
Stimulation parameters: carrier frequencies of 2000/2130 Hz (Δf = 130 Hz), with stimulation lasting 20 minutes on each side.
Before the intervention, T1-weighted structural images are acquired for each subject, and computational modeling based on an individual head model is performed to optimize electrode placement, individually focusing on the target side STN region.
The sham group follows the same procedure but does not receive effective stimulation.
The sham stimulation group receives only 30 seconds of fade-in/fade-out current at the beginning and end of the stimulation period to ensure blinding.
Studietyp
Interventionell
Inskrivning (Beräknad)
32
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Xiaoying Zhu, MD
- Telefonnummer: 86-13817659260
- E-post: docxiaoying@163.com
Studera Kontakt Backup
- Namn: Jingtao Feng, MD
- Telefonnummer: 86-18651285832
- E-post: fengjt0919@163.com
Studieorter
-
-
Shanghai Municipality
-
Shanghai, Shanghai Municipality, Kina, 200080
- Rekrytering
- Shanghai General Hospital
-
Kontakt:
- Xiaoying Zhu, MD
- Telefonnummer: 86-13817659260
- E-post: docxiaoying@163.com
-
Kontakt:
- Jingtao Feng, MD
- Telefonnummer: 86-18651285832
- E-post: fengjt0919@163.com
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Beskrivning
Inclusion Criteria:
- Aged 50-85 years, male or female.
- Diagnosed with "clinically established" or "clinically probable" Parkinson's disease according to the 2015 MDS Clinical Diagnostic Criteria for Parkinson's Disease.
- Hoehn-Yahr stage ≥ 2, and judged by the investigator to be able to cooperate in completing scale-based assessments and MRI examinations.
- Stable regimen of anti-Parkinsonian medication for at least 4 weeks before enrollment, and agreement to maintain a stable regimen during the main study phase unless medically necessary to change.
- Written informed consent signed by the study participant.
Exclusion Criteria:
- Non-primary Parkinson's disease or other parkinsonism / atypical parkinsonism.
- Previous receipt of invasive neuromodulation therapies such as deep brain stimulation (DBS) or other intracranial implantation/stereotactic brain surgery.
- Presence of contraindications or high-risk conditions for transcranial electrical stimulation (e.g., incompatible metal implants/implantable electrical stimulation devices, etc.), or judged by the investigator as unsuitable to receive transcranial electrical stimulation.
- Receipt of non-invasive neuromodulation interventions such as transcranial magnetic stimulation or transcranial electrical stimulation within the past six months.
- Presence of contraindications to MRI or inability to tolerate MRI examination.
- Significant cognitive impairment or severe psychiatric symptoms that prevent completion of assessments or result in poor compliance.
- New initiation or dose adjustment of medications or treatments that significantly affect sleep architecture/consciousness status within the past 4 weeks.
- History of epilepsy.
- Pregnancy or breastfeeding.
- Any other condition judged by the investigator as unsuitable for participation in the study.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Fyrdubbla
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: the experimental group
real stimulation
|
tTIS was targeted at the bilateral STN, with stimulation delivered once daily for 20 minutes per session, for a total of five consecutive days.
|
|
Sham Comparator: the control group
sham stimulation
|
The sham stimulation is administered using the same procedure as the real tTIS.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Changes of motor function in PD
Tidsram: Changes from baseline after 5 days of intervention (Day 5)
|
the scores of UPDRS III [OFF])
|
Changes from baseline after 5 days of intervention (Day 5)
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Changes of motor function in PD
Tidsram: Day 15, Day 35 (UPDRS III [OFF] ); Day 5, Day 15, Day 35 (UPDRS III [ON])
|
the scores of UPDRS III [OFF] and [ON]
|
Day 15, Day 35 (UPDRS III [OFF] ); Day 5, Day 15, Day 35 (UPDRS III [ON])
|
|
Changes of Motor Complications in PD
Tidsram: Day 5, Day 15, Day 35
|
the scores of UPDRS IV
|
Day 5, Day 15, Day 35
|
|
Assessment of changes in cognition
Tidsram: Day 5, Day 15, Day 35
|
the scores of MoCA
|
Day 5, Day 15, Day 35
|
|
Assessment of changes in anxiety
Tidsram: Day 5, Day 15, Day 35
|
the scores of HAMA
|
Day 5, Day 15, Day 35
|
|
Assessment of changes in depression
Tidsram: Day 5, Day 15, Day 35
|
the scores of HAMD
|
Day 5, Day 15, Day 35
|
|
Assessment of changes in sleep
Tidsram: Day 5, Day 15, Day 35
|
the scores of PSQI
|
Day 5, Day 15, Day 35
|
|
Assessment of changes in daytime sleepiness
Tidsram: Day 5, Day 15, Day 35
|
the scores of ESS
|
Day 5, Day 15, Day 35
|
|
Assessment of changes in RBD
Tidsram: Day 5, Day 15, Day 35
|
the scores of RBDSQ
|
Day 5, Day 15, Day 35
|
|
Assessment of changes in RLS
Tidsram: Day 5, Day 15, Day 35
|
the scores of IRLSRS
|
Day 5, Day 15, Day 35
|
|
Assessment of changes in Non-Motor Aspects of Experiences of Daily Living
Tidsram: Day 5, Day 15, Day 35
|
the scores of UPDRS I
|
Day 5, Day 15, Day 35
|
|
Assessment of changes in Motor Aspects of Experiences of Daily Living
Tidsram: Time Frame: Day 5, Day 15, Day 35
|
the scores of UPDRS II
|
Time Frame: Day 5, Day 15, Day 35
|
Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Changs of brain connectivity in the PD brain
Tidsram: After 5 days of intervention relative to baseline
|
functional magnetic resonance imaging (fMRI)
|
After 5 days of intervention relative to baseline
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
20 maj 2026
Primärt slutförande (Beräknad)
1 april 2027
Avslutad studie (Beräknad)
1 april 2027
Studieregistreringsdatum
Först inskickad
17 maj 2026
Först inskickad som uppfyllde QC-kriterierna
2 juni 2026
Första postat (Faktisk)
4 juni 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
4 juni 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
2 juni 2026
Senast verifierad
1 juni 2026
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- Shanghai1st-2026-tTIS
- No. 02.06.02.26.19 (Annat bidrag/finansieringsnummer: Basic and Clinical Collaborative Research Program of Shanghai General Hospital)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
JA
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
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Nej
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