Parkinson s DiseaseNCT07857824
Temporal Interference Stimulation for Motor and Non-motor Symptoms in Parkinson's Disease
An observational study of Parkinson s Disease, run by Tongji Hospital.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson s Disease
- What is being tested?
- transcranial temporal interference stimulation (tTIS)
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 10 Oct 2026to 10 Jun 2027
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official title: 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.
- Conditions
- Parkinson s Disease
- Being tested
- transcranial temporal interference stimulation (tTIS)
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcranial temporal interference stimulation (tTIS)Device
Participants in this group will receive transcranial temporal interference stimulation targeting the subthalamic nucleus using a frequency pair of 2000 Hz and 2130 Hz. Stimulation will be delivered twice daily at the same time for 30 minutes per session over five consecutive days（only once on the 5th day）. Stimulation intensity will be individually titrated starting from a low level and gradually increased to the maximum tolerable level. All treatments will be administered during the participant's medication "on" state.
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Score on Part III (Motor Examination) of the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
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.
Measured: 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.
Secondary outcomes (7)
MDS-UPDRS Scale Part I Non-Motor Function Score Changes
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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)
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.
Measured: 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)
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).
Measured: 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)
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.
Measured: 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)
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
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2026
- Study start10 Oct 2026 (estimated)
- Primary completion10 Jun 2027 (estimated)
- Study completion10 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson s DiseaseStudies of the same condition, open and under way.
- More trials run by Tongji HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tongji Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tang Zhouping, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07857824
- Sponsor's protocol ID
- 20260597
- Status last verified
- Sep 2026
- First submitted
- 29 Sep 2026
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Observational Cohort Study of Temporal Interference Stimulation Treatment for Improving Motor and Non-motor Symptoms in Patients With Parkinson's Disease
- ClinicalTrials.gov ID
- NCT07857824
- Acronym / sponsor ID
- 20260597
- Conditions
- Parkinson s Disease
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Tongji HospitalUniversity, hospital or other
- Study start
- 10 Oct 2026 (estimated)
- Primary completion
- 10 Jun 2027 (estimated)
- Study completion
- 10 Jun 2027 (estimated)
- First posted
- 5 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| transcranial temporal interference stimulation (tTIS)Participants in this group will receive transcranial temporal interference stimulation targeting the subthalamic nucleus using a frequency pair of 2000 Hz and 2130 Hz. Stimulation will be delivered twice daily at the same time for 30 minutes per session over five consecutive days（only once on the 5th day）. Stimulation intensity will be individually titrated starting from a low level and gradually increased to the maximum tolerable level. All treatments will be administered during the participant's medication "on" state. | Device | – |
Primary outcome
Change in Score on Part III (Motor Examination) of the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
Time frame: 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.
7 secondary outcomes
MDS-UPDRS Scale Part I Non-Motor Function Score Changes
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson s Disease, run by Tongji Hospital.
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 6 inclusion and 5 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: opening soon, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Score on Part III (Motor Examination) of the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) (time frame: 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.). 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 5 Oct 2026; AzTrials last refreshed its copy on 6 Nov 2026.