Parkinson's Disease (PD)STN-tTIS-PDNCT07625540
Subthalamic Nucleus-Targeted Transcranial Temporal Interference Stimulation for Motor and Non-Motor Symptoms in Parkinson's Disease
A study testing real transcranial temporal interference stimulation in people with Parkinson's Disease (PD), run by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial summary
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). 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?
- real transcranial temporal interference stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteChina
- Study dates
- 20 May 2026to 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
- 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.
Who cannot join
- 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.
Show all 10Show fewer
- 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.
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, 1 recruiting
- Recruiting
Shanghai General Hospital
Shanghai, Shanghai Municipality, 200080
Xiaoying Zhu, MD, 86-13817659260, docxiaoying@163.com
Jingtao Feng, MD, 86-18651285832, fengjt0919@163.com
About this study
Official title: 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).
Read the detailed description
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.
- Conditions
- Parkinson's Disease (PD)
- Being tested
- real transcranial temporal interference stimulation, sham transcranial temporal interference stimulation
- Keywords
- Parkinson's disease, transcranial Temporal Interference Stimulation, subthalamic nucleus, motor symptoms, non-motor symptoms
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
real transcranial temporal interference stimulationDevice
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 transcranial temporal interference stimulationDevice
The sham stimulation is administered using the same procedure as the real tTIS.
| Study group | Role | What they receive |
|---|---|---|
| the experimental group | Experimental | real stimulation Receives: Device: real transcranial temporal interference stimulation |
| the control group | Sham comparator | sham stimulation Receives: Device: sham transcranial temporal interference stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of motor function in PD
the scores of UPDRS III [OFF])
Measured: Changes from baseline after 5 days of intervention (Day 5)
Secondary outcomes (11)
Changes of motor function in PD
the scores of UPDRS III [OFF] and [ON]
Measured: Day 15, Day 35 （UPDRS III [OFF] ); Day 5, Day 15, Day 35 （UPDRS III [ON])
Changes of Motor Complications in PD
the scores of UPDRS IV
Measured: Day 5, Day 15, Day 35
Assessment of changes in cognition
the scores of MoCA
Measured: Day 5, Day 15, Day 35
Assessment of changes in anxiety
the scores of HAMA
Measured: Day 5, Day 15, Day 35
Assessment of changes in depression
the scores of HAMD
Measured: Day 5, Day 15, Day 35
Assessment of changes in sleep
the scores of PSQI
Measured: Day 5, Day 15, Day 35
Assessment of changes in daytime sleepiness
the scores of ESS
Measured: Day 5, Day 15, Day 35
Assessment of changes in RBD
the scores of RBDSQ
Measured: Day 5, Day 15, Day 35
Assessment of changes in RLS
the scores of IRLSRS
Measured: Day 5, Day 15, Day 35
Assessment of changes in Non-Motor Aspects of Experiences of Daily Living
the scores of UPDRS I
Measured: Day 5, Day 15, Day 35
Assessment of changes in Motor Aspects of Experiences of Daily Living
the scores of UPDRS II
Measured: Time Frame: Day 5, Day 15, Day 35
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2026
- Study start20 May 2026
- Primary completionApr 2027 (estimated)
- Study completionApr 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 Disease (PD)Studies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiaoying Zhu, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07625540
- Sponsor's protocol ID
- Shanghai1st-2026-tTIS
- Other IDs
- No. 02.06.02.26.19
- Acronym
- STN-tTIS-PD
- Status last verified
- Jun 2026
- First submitted
- 17 May 2026
- Last updated
- 4 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07625540
- Acronym / sponsor ID
- STN-tTIS-PD / Shanghai1st-2026-tTIS
- Conditions
- Parkinson's Disease (PD)
- Keywords
- Parkinson's disease, transcranial Temporal Interference Stimulation, subthalamic nucleus, motor symptoms, non-motor symptoms
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Shanghai General Hospital, Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- 20 May 2026 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 4 Jun 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.
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).
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| the experimental group | Experimental | Device: real transcranial temporal interference stimulationreal stimulation |
| the control group | Sham comparator | Device: sham transcranial temporal interference stimulationsham stimulation |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
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 |
|---|---|---|
| real transcranial temporal interference stimulationtTIS was targeted at the bilateral STN, with stimulation delivered once daily for 20 minutes per session, for a total of five consecutive days. | Device | the experimental group |
| sham transcranial temporal interference stimulationThe sham stimulation is administered using the same procedure as the real tTIS. | Device | the control group |
Primary outcome
Changes of motor function in PD
Time frame: Changes from baseline after 5 days of intervention (Day 5)
the scores of UPDRS III [OFF])
11 secondary outcomes
Changes of motor function in PD
Time frame: Day 15, Day 35 （UPDRS III [OFF] ); Day 5, Day 15, Day 35 （UPDRS III [ON])
Changes of Motor Complications in PD
Time frame: Day 5, Day 15, Day 35
Assessment of changes in cognition
Time frame: Day 5, Day 15, Day 35
Assessment of changes in anxiety
Time frame: Day 5, Day 15, Day 35
Assessment of changes in depression
Time frame: Day 5, Day 15, Day 35
Assessment of changes in sleep
Time frame: Day 5, Day 15, Day 35
Assessment of changes in daytime sleepiness
Time frame: Day 5, Day 15, Day 35
Assessment of changes in RBD
Time frame: Day 5, Day 15, Day 35
Assessment of changes in RLS
Time frame: Day 5, Day 15, Day 35
Assessment of changes in Non-Motor Aspects of Experiences of Daily Living
Time frame: Day 5, Day 15, Day 35
Assessment of changes in Motor Aspects of Experiences of Daily Living
Time frame: Time Frame: Day 5, Day 15, Day 35
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 4 Jun 2026.
- Individual participant dataSharing planned: Yes
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing real transcranial temporal interference stimulation in people with Parkinson's Disease (PD), run by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine 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 5 inclusion and 10 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 4 Jun 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. Some participants in this study may receive a placebo. 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 Xiaoying Zhu, MD (86-13817659260, docxiaoying@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes of motor function in PD (time frame: Changes from baseline after 5 days of intervention (Day 5)). 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 4 Jun 2026.