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Parkinson's Disease (PD)NCT07774312

STN-tTIS With Different Intervention Intervals Versus Standard Medical Treatment for Parkinson's Disease

A study testing STN-tTIS Once Weekly, STN-tTIS Twice Weekly and STN-tTIS Five Times Weekly in people with Parkinson's Disease (PD), run by Ruijin Hospital at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The goal of this clinical trial is to compare the efficacy and safety of different Intervention Intervals of subthalamic nucleus-targeted transcranial temporal interference stimulation (STN-tTIS) in patients with Parkinson disease. Read more about this study

Who is it for?
Ages 50 to 85 years
Conditions the study is for
Parkinson's Disease (PD)
What is being tested?
STN-tTIS Once Weekly, STN-tTIS Twice Weekly and STN-tTIS Five Times Weekly
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteChina
Study dates
27 Jul 2026to 15 Apr 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 1.Aged 50-85 years, male or female.
  • 2.Diagnosed with idiopathic Parkinson disease (PD) in accordance with the Chinese Guidelines for the Diagnosis and Treatment of Parkinson's Disease (4th Edition), with a confirmed diagnosis for at least 6 months and a stable condition, defined as no significant deterioration or major medication adjustment within the past month.
  • 3.Receiving stable doses of antiparkinsonian medication (e.g., levodopa or dopamine agonists) and willing to maintain the medication regimen during the study.
  • 4.Hoehn and Yahr stage 1-3 in the medication ON state.
  • 5.Baseline MDS-UPDRS Part III total score ≥20 in the medication ON state.
  • 6.No history of non-invasive neuromodulation therapy, or discontinuation of such therapy for at least 3 months before enrollment if previously received.
  • 7.Normal cognitive function (MoCA score ≥24) and able to cooperate with tTIS intervention, clinical scale assessments, and basic smartphone- and smartwatch-assisted home-based motor self-assessments.
  • 8.Able and willing to provide written informed consent and complete all required study procedures and follow-up assessments.

Who cannot join

  • 1.Other neurological disorders that may affect motor or cognitive function.
  • 2.Contraindications to magnetic resonance imaging (MRI), such as claustrophobia.
  • 3.History of taking antipsychotics, antidepressants, or other medications affecting dopamine levels.
  • 4.Psychiatric disorders (e.g., depression or schizophrenia), substance abuse, or alcohol dependence.
  • 5.Implanted medical devices (e.g., pacemaker or defibrillator), metal implants in the cranium or spine, a personal or family history of epilepsy, or severe skull defects.
  • 6.Previous deep brain stimulation (DBS) or other intracranial implantation surgery, or participation in another Parkinson disease clinical trial within the past 3 months.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Chencheng Zhang, MD, PHD contact

13381827024

i@cchang.org

China1 site, 1 recruiting
  • Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

    Shanghai, Shanghai Municipality, 200025

    Chencheng Zhang, MD, PHD, 13381827024, i@cchang.org

    Recruiting

Other trials in China

About this study

Official title: STN-targeted Temporal Interference Stimulation With Different Intervention Intervals Versus Standard Medical Treatment for Parkinson's Disease: A Multicenter, Randomized, Controlled Trial

The goal of this clinical trial is to compare the efficacy and safety of different Intervention Intervals of subthalamic nucleus-targeted transcranial temporal interference stimulation (STN-tTIS) in patients with Parkinson disease.

Previous studies suggest that STN-tTIS may improve motor symptoms in people with Parkinson disease. However, most previous studies evaluated only one stimulation session. It remains unclear how often STN-tTIS should be administered during a repeated treatment course and whether shorter intervention intervals stimulation produces greater or longer-lasting improvement without increasing adverse events.

Read more

The main questions this study aims to answer are:

  1. Does STN-tTIS administered five times weekly improve motor symptoms more than standard medication treatment alone at the end of the 2-week treatment period?
  2. Do once-weekly, twice-weekly, and five-times-weekly STN-tTIS produce different changes in motor symptoms?
  3. Does the STN-tTIS intervention intervals influence how long its effects persist after treatment?
  4. Do the different intervention intervals have different effects on non-motor symptoms, quality of life, cognitive function, and safety?

Participants will be randomly assigned to receive STN-tTIS once weekly, twice weekly, or five times weekly for 2 weeks, or to continue standard antiparkinsonian medication without additional stimulation. All participants will maintain a stable medication regimen during the study. Their motor and non-motor symptoms will be assessed during the treatment period and during a subsequent 2-week follow-up period.

Read the detailed description

Parkinson disease (PD) is a progressive neurodegenerative disorder characterized by both motor and non-motor symptoms that substantially impair quality of life. Although pharmacological therapy remains the standard treatment, long-term medication use is frequently associated with motor fluctuations and treatment-related complications. Transcranial temporal interference stimulation (tTIS) is a novel noninvasive neuromodulation technique capable of selectively modulating deep brain structures without surgery. Previous pilot studies have demonstrated that subthalamic nucleus-targeted tTIS (STN-tTIS) may improve motor symptoms in patients with PD. However, existing studies have primarily evaluated the immediate effects of single-session stimulation, and the optimal intervention interval for repeated STN-tTIS has not yet been established.

The objective of this multicenter clinical trial is to evaluate whether different intervention intervals, defined as once-weekly, twice-weekly, and five-times-weekly STN-tTIS administration, result in different therapeutic effects in patients with PD and to compare their efficacy and safety. The study will also investigate whether the intervention interval influences the durability of clinical improvement following completion of the intervention.

Approximately 60 participants with PD will be enrolled and randomly assigned to one of three active STN-tTIS treatment groups with different intervention intervals or to a control group receiving standard medical therapy alone. All participants will continue a stable antiparkinsonian medication regimen throughout the study. The treatment period will last 2 weeks, followed by a 2-week follow-up period. Clinical efficacy will be evaluated primarily by changes in motor symptoms, while additional assessments will evaluate non-motor symptoms, sleep, quality of life, cognitive function, and safety. This study will provide information regarding the influence of intervention intervals on the efficacy and safety of repeated STN-tTIS in patients with Parkinson disease and may help inform future treatment strategies.

Being tested
STN-tTIS Once Weekly, STN-tTIS Twice Weekly, STN-tTIS Five Times Weekly, Standard Antiparkinsonian Medication
Keywords
Subthalamic nucleus, Transcranial Temporal Interference Stimulation, Intervention Intervals
Medical subject headings
Parkinson Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • STN-tTIS Once WeeklyDevice

    Also called Transcranial Temporal Interference Stimulation

    Participants receive subthalamic nucleus-targeted transcranial temporal interference stimulation (STN-tTIS) once weekly for 2 weeks. Each stimulation session lasts 20 minutes. Two high-frequency alternating currents at 2000 Hz and 2130 Hz are delivered through two pairs of scalp electrodes, generating a 130-Hz temporal interference envelope targeting the subthalamic nucleus. Stable antiparkinsonian medication is maintained throughout the intervention period.

  • STN-tTIS Twice WeeklyDevice

    Also called Transcranial Temporal Interference Stimulation

    Participants receive subthalamic nucleus-targeted transcranial temporal interference stimulation (STN-tTIS) twice weekly for 2 weeks. Each stimulation session lasts 20 minutes. Two high-frequency alternating currents at 2000 Hz and 2130 Hz are delivered through two pairs of scalp electrodes, generating a 130-Hz temporal interference envelope targeting the subthalamic nucleus. Stable antiparkinsonian medication is maintained throughout the intervention period.

  • STN-tTIS Five Times WeeklyDevice

    Also called Transcranial Temporal Interference Stimulation

    Participants receive subthalamic nucleus-targeted transcranial temporal interference stimulation (STN-tTIS) five times weekly for 2 weeks. Each stimulation session lasts 20 minutes. Two high-frequency alternating currents at 2000 Hz and 2130 Hz are delivered through two pairs of scalp electrodes, generating a 130-Hz temporal interference envelope targeting the subthalamic nucleus. Stable antiparkinsonian medication is maintained throughout the intervention period.

  • Standard Antiparkinsonian MedicationDrug

    Participants continue their stable antiparkinsonian medication regimen throughout the 2-week study intervention period. No additional STN-tTIS is administered.

Study groups in NCT07774312
Study groupRoleWhat they receive
STN-tTIS Once WeeklyExperimentalParticipants receive STN-targeted transcranial temporal interference stimulation (STN-tTIS) once weekly for 2 weeks in addition to stable antiparkinsonian medication.
Receives: Device: STN-tTIS Once Weekly; Drug: Standard Antiparkinsonian Medication
STN-tTIS Twice WeeklyExperimentalParticipants receive STN-targeted transcranial temporal interference stimulation (STN-tTIS) twice weekly for 2 weeks in addition to stable antiparkinsonian medication.
Receives: Device: STN-tTIS Twice Weekly; Drug: Standard Antiparkinsonian Medication
STN-tTIS Five Times WeeklyExperimentalParticipants receive STN-targeted transcranial temporal interference stimulation (STN-tTIS) five times weekly for 2 weeks in addition to stable antiparkinsonian medication.
Receives: Device: STN-tTIS Five Times Weekly; Drug: Standard Antiparkinsonian Medication
Standard Medical Therapy AloneActive comparatorParticipants continue their stable antiparkinsonian medication regimen for 2 weeks without additional STN-tTIS.
Receives: Drug: Standard Antiparkinsonian Medication

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change From Baseline in MDS-UPDRS Part III Total Score at the End of the Intervention Period

    The Movement Disorder Society-Unified Parkinson's Disease Rating Scale Part III (MDS-UPDRS Part III) is used to assess the severity of motor symptoms in Parkinson disease. The total score ranges from 0 to 132, with higher scores indicating greater motor impairment. The primary outcome is the change in MDS-UPDRS Part III total score from baseline to Day 12, corresponding to the end of the 2-week intervention period. Assessments are performed during the ON medication state. A greater reduction from baseline indicates greater improvement in motor symptoms.

    Measured: Baseline to Day 12

Secondary outcomes (6)
  1. Change From Baseline in MDS-UPDRS Part I Score

    The Movement Disorder Society-Unified Parkinson's Disease Rating Scale Part I (MDS-UPDRS Part I) assesses non-motor aspects of experiences of daily living in Parkinson disease. Scores will be assessed at baseline, Day 12, and Day 27. Higher scores indicate greater impairment. Changes from baseline will be compared among the study groups.

    Measured: Baseline to Day 12 and Day 27

  2. Change From Baseline in MDS-UPDRS Part II Score

    The MDS-UPDRS Part II assesses motor aspects of experiences of daily living in Parkinson disease. Scores will be assessed at baseline, Day 12, and Day 27. Higher scores indicate greater impairment. Changes from baseline will be compared among the study groups.

    Measured: Baseline to Day 12 and Day 27

  3. Change From Baseline in MDS-UPDRS Part IV Score

    The MDS-UPDRS Part IV assesses motor complications associated with Parkinson disease, including motor fluctuations and dyskinesias. Scores will be assessed at baseline, Day 12, and Day 27. Higher scores indicate greater motor complications. Changes from baseline will be compared among the study groups

    Measured: Baseline to Day 12 and Day 27

  4. Change From Baseline in Non-Motor Symptoms Scale (NMSS) Score

    The Non-Motor Symptoms Scale (NMSS) is used to assess the severity and frequency of non-motor symptoms associated with Parkinson disease. Higher scores indicate a greater burden of non-motor symptoms. NMSS scores will be assessed at baseline, Day 12, and Day 27, and changes from baseline will be compared among the study groups.

    Measured: Baseline to Day 12 and Day 27

  5. Change From Baseline in Parkinson's Disease Questionnaire-39 (PDQ-39) Score

    The Parkinson's Disease Questionnaire-39 (PDQ-39) is a patient-reported measure of Parkinson disease-related quality of life. Higher scores indicate poorer health-related quality of life. PDQ-39 scores will be assessed at baseline, Day 12, and Day 27, and changes from baseline will be compared among the study groups.

    Measured: Baseline to Day 12 and Day 27

  6. Change From Baseline in Parkinson's Disease Sleep Scale (PDSS) Score

    The Parkinson's Disease Sleep Scale (PDSS) is used to assess sleep-related symptoms in patients with Parkinson disease. PDSS scores will be assessed at baseline, Day 12, and Day 27, and changes from baseline will be compared among the study groups.

    Measured: Baseline to Day 12 and Day 27

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Aug 2026
  2. Study start27 Jul 2026
  3. Primary completion15 Mar 2027 (estimated)
  4. Study completion15 Apr 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Participants will be randomly assigned in a 1:1:1:1 ratio to one of three STN-tTIS groups with different intervention intervals or to a control group receiving standard medical therapy alone. Each participant will remain in the assigned group throughout the study.
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07774312
Sponsor's protocol ID
2026380
Status last verified
Jul 2026
First submitted
17 Aug 2026
Last updated
21 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing STN-tTIS Once Weekly, STN-tTIS Twice Weekly and STN-tTIS Five Times Weekly in people with Parkinson's Disease (PD), run by Ruijin Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 21 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Chencheng Zhang, MD, PHD (13381827024, i@cchang.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in MDS-UPDRS Part III Total Score at the End of the Intervention Period (time frame: Baseline to Day 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2026.

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