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Parkinson's DiseaseNCT07698236

Temporal Interference Noninvasive Deep Brain Stimulation for Idiopathic Parkinson's Disease and Parkinsonian Syndromes: Effects and Target Exploration

A study testing AB Temporal Interference Stimulation and BA Temporal Interference Stimulation in people with Parkinson's Disease and Parkinsonian Syndromes, run by Ruijin Hospital at 1 site in China.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial summary

This study aims to explore the therapeutic effects of noninvasive deep brain electrical stimulation using temporal interference principles (Temporal Interference Stimulation, TIS) on both motor and non-motor symptoms in patients with idiopathic Parkinson's disease and Parkinsonian syndromes, and to investigate… Read more about this study

Who is it for?
Ages 40 to 80 years
Conditions the study is for
Parkinson's Disease, Parkinsonian Syndromes
What is being tested?
AB Temporal Interference Stimulation and BA Temporal Interference Stimulation
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteChina
Study dates
3 Jul 2026to 30 Sep 2026
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 40 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Aged 40 to 80 years, diagnosed with idiopathic Parkinson's disease or Parkinsonian syndromes according to the Movement Disorder Society (MDS) diagnostic criteria.
  • Receiving stable doses of levodopa or other dopaminergic medications for at least 4 weeks prior to enrollment, with a documented response to levodopa; medication regimen must remain unchanged during the study.
  • Hoehn and Yahr (H\&Y) stage ≤ 3 in the "ON" medication state.
  • Normal cognitive function, defined as a Mini-Mental State Examination (MMSE) score ≥ 24.
  • Able to maintain and cooperate with Parkinson's disease symptom diaries.
  • Signed written informed consent.

Who cannot join

  • Presence of other neurological or psychiatric disorders that may interfere with study participation or outcomes.
  • Previous treatment with deep brain stimulation (DBS) or other invasive brain stimulation therapies.
  • Orthopedic or other medical conditions that could affect gait or balance.
  • Contraindications to MRI, such as claustrophobia or other factors making MRI unsuitable.
  • History of taking antipsychotic, antidepressant, or other medications that may affect dopamine levels.
  • Contraindications to electrical stimulation, such as implanted cardiac pacemakers or a history of epilepsy.
  • History of electroconvulsive therapy (ECT).
  • Severe comorbidities, including cardiovascular disease, respiratory disease, or hepatic/renal dysfunction.

Trial locations and contacts

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

China1 site
  • Shanghai Jiao Tong University School of Medicine Affiliated Ruijin Hospital

    Shanghai

Other trials in China

About this study

Official title: A Study on the Therapeutic Effects and Target Exploration of Temporal Interference-Based Noninvasive Deep Brain Stimulation in Patients With Idiopathic Parkinson's Disease and Parkinsonian Syndromes

This study aims to explore the therapeutic effects of noninvasive deep brain electrical stimulation using temporal interference principles (Temporal Interference Stimulation, TIS) on both motor and non-motor symptoms in patients with idiopathic Parkinson's disease and Parkinsonian syndromes, and to investigate strategies for optimal stimulation target selection. A prospective, single-center, double-blind, randomized, crossover design will be implemented. Participants will be recruited from outpatient and inpatient departments of Ruijin Hospital, Shanghai Jiao Tong University School of Medicine. The primary hypothesis is that TIS will significantly improve motor symptoms in patients with Parkinson's disease and Parkinsonian syndromes. The primary outcome measure will be the change in the MDS-UPDRS Part III score from baseline to post-stimulation.

This study is expected to provide direct evidence supporting the clinical application and target selection strategies of noninvasive deep brain stimulation for the treatment of Parkinson's disease and Parkinsonian syndromes.

Being tested
AB Temporal Interference Stimulation, BA Temporal Interference Stimulation
Keywords
Parkinson's Disease and Parkinsonian Syndromes, Temporal Interference Noninvasive Deep Brain Stimulation
Medical subject headings
Parkinson Disease, Parkinsonian Disorders

What participants receive

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

  • AB Temporal Interference StimulationDevice

    Participants with PD or PDS receive TIS. Each session lasts 30 minutes for 3 consecutive days. The study uses a crossover design with AB sequence (Active → Sham). Active stimulation: current 1.5-4 mA (patient's maximum tolerated), carrier frequency 2000 Hz, frequency offset 130 Hz; Sham stimulation: current 1.5-4 mA, carrier frequency 2000 Hz, frequency offset 0 Hz.

  • BA Temporal Interference StimulationDevice

    Participants with PD or PDS receive TIS. Each session lasts 30 minutes for 3 consecutive days. The study uses a crossover design with BA sequence (Sham → Active). Sham stimulation: current 1.5-4 mA, carrier frequency 2000 Hz, frequency offset 0 Hz. Active stimulation: current 1.5-4 mA (patient's maximum tolerated), carrier frequency 2000 Hz, frequency offset 130 Hz;

Study groups in NCT07698236
Study groupRoleWhat they receive
GPi TISExperimentalParticipants with PD or PDS receive TIS targeting the contralateral globus pallidus internus (GPi). Each group consists of 10 patients with PD and 10 patients with PDS.
Receives: Device: AB Temporal Interference Stimulation; Device: BA Temporal Interference Stimulation
STN TISExperimentalParticipants with PD or PDS receive TIS targeting the contralateral subthalamic nucleus (STN). Each group consists of 10 patients with PD and 10 patients with Parkinsonian syndromes.
Receives: Device: AB Temporal Interference Stimulation; Device: BA Temporal Interference Stimulation
Putamen TISExperimentalParticipants with PD or PDS receive TIS targeting the contralateral putamen. Each group consists of 10 patients with PD and 10 patients with Parkinsonian syndromes.
Receives: Device: AB Temporal Interference Stimulation; Device: BA Temporal Interference Stimulation
LHA TISExperimentalParticipants with PD or PDS receive TIS targeting the contralateral lateral hypothalamic area (LHA). Each group consists of 10 patients with PD and 10 patients with Parkinsonian syndromes.
Receives: Device: AB Temporal Interference Stimulation; Device: BA Temporal Interference Stimulation
Dentate TISExperimentalParticipants with PD or PDS receive TIS targeting the ipsilateral cerebellar dentate nucleus. Each group consists of 10 patients with PD and 10 patients with Parkinsonian syndromes.
Receives: Device: AB Temporal Interference Stimulation; Device: BA Temporal Interference Stimulation

What is being measured

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

  1. Efficacy of temporal interference stimulation (TIS) on motor symptoms in patients with idiopathic Parkinson's disease and Parkinsonian syndromes

    The MDS-UPDRS Part III is a rater-administered motor examination used to evaluate the severity of motor impairment in patients with idiopathic Parkinson's disease and Parkinsonian syndromes. The total score ranges from 0 to 132, with lower scores indicating less severe motor symptoms. Changes from baseline after real or sham stimulation will be analyzed and compared between groups.

    Measured: Baseline, 3 days after sham stimulation, and 3 days after active stimulation.

Secondary outcomes (15)
  1. Secondary motor outcome

    The UMSARS is a rater-administered scale used to assess disease severity in patients with Parkinsonian syndromes, particularly multiple system atrophy. The total score ranges from 0 to 104, with a higher score indicating greater disease severity. The change in UMSARS score from baseline to after stimulation will be compared between the real and sham stimulation groups.

    Measured: Baseline, 3 days after sham stimulation, and 3 days after active stimulation.

  2. Secondary motor outcome

    The Freezing of Gait Questionnaire is used to assess the severity and frequency of freezing of gait in patients with idiopathic Parkinson's disease and Parkinsonian syndromes. The total score ranges from 0 to 24, with a higher score indicating more severe freezing of gait. The change in FOGQ score from baseline to after stimulation will be compared between the real and sham stimulation groups.

    Measured: Baseline, 3 days after sham stimulation, and 3 days after active stimulation.

  3. Secondary motor outcome

    The Berg Balance Scale is a rater-administered scale used to assess balance function and fall risk. The total score ranges from 0 to 56, with a higher score indicating better balance function. The change in Berg Balance Scale score from baseline to after stimulation will be compared between the real and sham stimulation groups.

    Measured: Baseline, 3 days after sham stimulation, and 3 days after active stimulation.

  4. Efficacy of TIS on non-motor symptoms in patients with idiopathic Parkinson's disease and Parkinsonian syndromes

    The Hamilton Anxiety Rating Scale-14(HAMA-14)is a rater-administered scale used to assess the severity of anxiety symptoms. The total score ranges from 0 to 56, with a higher score indicating more severe anxiety. The change in HAMA-14 score from baseline to after stimulation will be compared between the real and sham stimulation groups.

    Measured: Baseline, 3 days after sham stimulation, and 3 days after active stimulation.

  5. Efficacy of TIS on non-motor symptoms in patients with idiopathic Parkinson's disease and Parkinsonian syndromes

    The Hamilton Depression Rating Scale-17(HAMD-17)is a rater-administered scale used to assess the severity of depressive symptoms. The total score ranges from 0 to 52, with a higher score indicating more severe depression. The change in HAMD-17 score from baseline to after stimulation will be compared between the real and sham stimulation groups.

    Measured: Baseline, 3 days after sham stimulation, and 3 days after active stimulation.

  6. Efficacy of TIS on non-motor symptoms in patients with idiopathic Parkinson's disease and Parkinsonian syndromes

    The Mini-Mental State Examination(MMSE)is a brief cognitive screening scale used to assess global cognitive function. The total score ranges from 0 to 30, with a higher score indicating better cognitive function. The change in MMSE score from baseline to after stimulation will be compared between the real and sham stimulation groups.

    Measured: Baseline, 3 days after sham stimulation, and 3 days after active stimulation.

  7. Efficacy of TIS on non-motor symptoms in patients with idiopathic Parkinson's disease and Parkinsonian syndromes

    The Montreal Cognitive Assessment(MoCA)is a brief cognitive screening scale used to assess global cognitive function, particularly mild cognitive impairment. The total score ranges from 0 to 30, with a higher score indicating better cognitive function. The change in MoCA score from baseline to after stimulation will be compared between the real and sham stimulation groups.

    Measured: Baseline, 3 days after sham stimulation, and 3 days after active stimulation.

  8. Efficacy of TIS on non-motor symptoms in patients with idiopathic Parkinson's disease and Parkinsonian syndromes

    The Non-Motor Symptoms Scale(NMSS)is a rater-administered scale used to assess the severity and frequency of non-motor symptoms in patients with Parkinson's disease and Parkinsonian syndromes. The total score ranges from 0 to 360, with a higher score indicating a greater non-motor symptom burden. The change in NMSS score from baseline to after stimulation will be compared between the real and sham stimulation groups.

    Measured: Baseline, 3 days after sham stimulation, and 3 days after active stimulation.

  9. Efficacy of TIS on non-motor symptoms in patients with idiopathic Parkinson's disease and Parkinsonian syndromes

    The Scales for Outcomes in Parkinson's Disease-Autonomic Dysfunction(SCOPA-AUT)is a patient-reported scale used to assess autonomic symptoms in patients with Parkinson's disease and Parkinsonian syndromes. The total score ranges from 0 to 69, with a higher score indicating more severe autonomic dysfunction. The change in SCOPA-AUT score from baseline to after stimulation will be compared between the real and sham stimulation groups.

    Measured: Baseline, 3 days after sham stimulation, and 3 days after active stimulation.

  10. Efficacy of TIS on quality of life in patients with idiopathic Parkinson's disease and Parkinsonian syndromes

    The Parkinson's Disease Questionnaire-39 Summary Index(PDQ-39 SI)is a patient-reported scale used to assess health-related quality of life in patients with Parkinson's disease and Parkinsonian syndromes. The total score ranges from 0 to 100, with a higher score indicating poorer quality of life. The change in PDQ-39 SI score from baseline to after stimulation will be compared between the real and sham stimulation groups.

    Measured: Baseline, 3 days after sham stimulation, and 3 days after active stimulation.

  11. Efficacy of TIS on quality of life in patients with idiopathic Parkinson's disease and Parkinsonian syndromes

    The MDS-UPDRS Part I is used to assess non-motor experiences of daily living in patients with idiopathic Parkinson's disease and Parkinsonian syndromes. The total score ranges from 0 to 52, with a higher score indicating more severe non-motor symptom burden. The change in MDS-UPDRS Part I score from baseline to after stimulation will be compared between the real and sham stimulation groups.

    Measured: Baseline, 3 days after sham stimulation, and 3 days after active stimulation.

  12. Efficacy of TIS on quality of life in patients with idiopathic Parkinson's disease and Parkinsonian syndromes

    The MDS-UPDRS Part II is used to assess motor experiences of daily living in patients with idiopathic Parkinson's disease and Parkinsonian syndromes. The total score ranges from 0 to 52, with a higher score indicating greater motor-related impairment in daily living. The change in MDS-UPDRS Part II score from baseline to after stimulation will be compared between the real and sham stimulation groups.

    Measured: Baseline, 3 days after sham stimulation, and 3 days after active stimulation.

  13. Potential mechanisms underlying the therapeutic effects of TIS in patients with idiopathic Parkinson's disease and Parkinsonian syndromes

    Changes in resting-state EEG β-band oscillation power before and after stimulation

    Measured: Baseline, 3 days after sham stimulation, and 3 days after active stimulation.

  14. Potential mechanisms underlying the therapeutic effects of TIS in patients with idiopathic Parkinson's disease and Parkinsonian syndromes

    Changes in whole-brain resting-state fMRI functional connectivity strength, with exploratory analyses focusing on the sensorimotor and basal ganglia networks, before and after stimulation

    Measured: Baseline, 3 days after sham stimulation, and 3 days after active stimulation.

  15. Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)

    The number and severity of all AEs and SAEs will be collected and monitored throughout the study to evaluate the safety and tolerability of the intervention.

    Measured: From baseline through study completion (up to 3 weeks)

Timeline

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

  1. First posted13 Jul 2026
  2. Study start3 Jul 2026
  3. Primary completion30 Sep 2026 (estimated)
  4. Study completion30 Sep 2026 (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
Crossover
Masking
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07698236
Sponsor's protocol ID
2025-622
Status last verified
Jul 2026
First submitted
8 Dec 2025
Last updated
13 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing AB Temporal Interference Stimulation and BA Temporal Interference Stimulation in people with Parkinson's Disease and Parkinsonian Syndromes, 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 6 inclusion and 8 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: enrolling by invitation, as of the sponsor's last update on 13 Jul 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?

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?

Efficacy of temporal interference stimulation (TIS) on motor symptoms in patients with idiopathic Parkinson's disease and Parkinsonian syndromes (time frame: Baseline, 3 days after sham stimulation, and 3 days after active stimulation.). 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 13 Jul 2026.

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