PARKINSON DISEASE (Disorder)PD TISNCT07480317
TIS for Brain Network Modulation and Clinical Efficacy in Parkinson's Disease
A study testing Temporal Interference Stimulation (130 Hz) and Temporal Interference Stimulation (40 Hz) in people with PARKINSON DISEASE (Disorder), run by Jiangsu Province Nanjing Brain Hospital at 1 site in China.
Trial summary
Parkinson's disease (PD) is a neurodegenerative disorder characterized by motor dysfunction. While deep brain stimulation (DBS) is effective, its invasive nature limits its application in early-stage patients. Read more about this study
- Who is it for?
- Ages 45 to 65 years
- Conditions the study is for
- PARKINSON DISEASE (Disorder)
- What is being tested?
- Temporal Interference Stimulation (130 Hz) and Temporal Interference Stimulation (40 Hz)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 1 siteChina
- Study dates
- 20 Mar 2026to 31 Mar 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 45 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with Parkinson's Disease according to the Movement Disorder Society (MDS) clinical diagnostic criteria.
- Hoehn \& Yahr Stage I-III (mild to moderate severity).
- Aged 45 to 65 years.
- Right-handed. Stable medication regimen for at least 1 hour before Phase A fMRI sessions and agreement to maintain a stable dosage during the 2-week Phase B intervention (unless clinically necessary).
- Able to provide informed consent by the participant or a legal guardian.
Who cannot join
- MRI contraindications, such as implanted DBS electrodes, cardiac pacemakers, or other metal implants.
- Significant cognitive impairment (MoCA score < 24) or severe psychiatric symptoms.
- History of epilepsy or structural brain lesions, including severe cerebral atrophy or cerebrovascular disease.
- Severe head tremors that would interfere with MRI scanning quality.
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
Nanjing Brain Hospital (Affiliated Brain Hospital of Nanjing Medical University)
Nanjing, Jiangsu, 210029
About this study
Official title: Mechanism of Temporal Interference Stimulation on Brain Networks and Its Long-term Clinical Efficacy in Parkinson's Disease
Parkinson's disease (PD) is a neurodegenerative disorder characterized by motor dysfunction. While deep brain stimulation (DBS) is effective, its invasive nature limits its application in early-stage patients. Temporal interference stimulation (TIS) is a novel non-invasive technique that can target deep brain structures like the globus pallidus internus (GPi) by using high-frequency electric fields.
This study aims to evaluate the clinical value and underlying mechanisms of TIS in PD patients. The research is divided into two phases: Phase A investigates the immediate regulatory effects of 130 Hz and 40 Hz TIS on brain networks using concurrent fMRI-TIS. Phase B is a randomized, double-blind, sham-controlled trial to assess the long-term efficacy and safety of a 2-week TIS intervention on both motor and non-motor symptoms. The results will help clarify how TIS modulates deep brain networks and its potential as a non-invasive therapy for PD.
Read the detailed description
This study employs a two-phase design to systematically investigate the effects of Temporal Interference Stimulation (TIS) on Parkinson's Disease (PD).
Phase A: Acute fMRI Mechanism Study (n=15) In this crossover study, participants will undergo concurrent fMRI-TIS sessions. Two frequency envelopes will be tested: 130 Hz (to mimic DBS inhibitory effects) and 40 Hz (for gamma entrainment). The fMRI protocol follows an 8-20-8 minute design: 8 minutes of baseline, 20 minutes of concurrent stimulation, and 8 minutes of post-stimulation scan . Individualized electric field modeling based on high-resolution 3D-T1 MRI will be used to target the right GPi. Acute motor changes will be assessed using the MDS-UPDRS-III scale.
Phase B: Long-term Efficacy RCT (n=60) Participants will be randomly assigned to one of three parallel groups: 130 Hz TIS, 40 Hz TIS, or Sham stimulation. The intervention consists of 30-minute daily sessions for 2 weeks (10 sessions total).
Active Groups: TIS targeting the right GPi with individualized electrode configurations.
Sham Group: 20-second ramp-up and ramp-down to mimic skin sensation without continuous stimulation.
Clinical assessments including motor function (MDS-UPDRS), cognition (MoCA), mood (HAMD/HAMA), and sleep (PDSS-2) will be conducted at baseline, after the 2-week intervention, and at a 1-month follow-up . Long-term neuroplasticity will also be evaluated using multi-modal MRI post-intervention.
- Conditions
- PARKINSON DISEASE (Disorder)
- Being tested
- Temporal Interference Stimulation (130 Hz), Temporal Interference Stimulation (40 Hz), Sham Temporal Interference Stimulation
- Keywords
- Temporal Interference Stimulation (TIS), Functional Magnetic Resonance Imaging (fMRI), Non-invasive Brain Stimulation (NIBS), Neuromodulation
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Temporal Interference Stimulation (130 Hz)Device
High-frequency sinewave currents (carrier frequency: 2000 Hz and 2130 Hz) are delivered via two pairs of scalp electrodes. The current intensity is 2-4 mA (individualized). In Phase B, stimulation lasts 30 minutes daily for 2 weeks (10 sessions).
Temporal Interference Stimulation (40 Hz)Device
High-frequency sinewave currents (carrier frequency: 2000 Hz and 2040 Hz) are delivered via two pairs of scalp electrodes. Parameters are identical to the 130 Hz group except for the envelope frequency.
Sham Temporal Interference StimulationDevice
The device provides only a 20-second ramp-up and 20-second ramp-down of current to mimic the skin sensation of active stimulation, without continuous therapeutic stimulation.
| Study group | Role | What they receive |
|---|---|---|
| 130 Hz TIS Group | Experimental | Participants receive active Temporal Interference Stimulation (TIS) with a 130 Hz envelope frequency targeting the right globus pallidus internus (GPi). Receives: Device: Temporal Interference Stimulation (130 Hz) |
| 40 Hz TIS Group | Experimental | Participants receive active TIS with a 40 Hz envelope frequency targeting the right GPi. Receives: Device: Temporal Interference Stimulation (40 Hz) |
| Sham Group | Sham comparator | Participants receive sham stimulation targeting the right GPi. Receives: Device: Sham Temporal Interference Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Movement Disorder Society-Unified Parkinson's Disease Rating Scale Part III (MDS-UPDRS-III) total score.
The MDS-UPDRS Part III is a clinician-rated scale used to assess the motor signs of Parkinson's disease. It includes 18 items (33 scores total), with each item ranging from 0 (normal) to 4 (severe). The total score ranges from 0 to 132, where higher scores represent greater motor impairment.
Measured: Baseline, 2 weeks (immediately after the 10th intervention session), and 1 month (follow-up).
Secondary outcomes (1)
Changes in Brain Network Functional Connectivity and Amplitude of Low-frequency Fluctuations (ALFF).
Assessed using resting-state fMRI to quantify the acute and long-term regulatory effects of TIS on the basal ganglia-thalamus-cortical circuit.
Measured: Baseline, 20 minutes (during concurrent TIS), and 8 minutes (immediately post-stimulation) for Phase A ; Baseline and 2 weeks for Phase B.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2026
- Study start20 Mar 2026 (estimated)
- Primary completion31 Aug 2026 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PARKINSON DISEASE (Disorder)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
- Model description
- This study follows a two-phase design: Phase A is a randomized crossover mechanism study (n=15). Phase B is a 3-arm parallel-group, randomized, double-blind efficacy study (n=60).
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu Province Nanjing Brain Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Weiguo Liu, Jiangsu Province Nanjing Brain Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07480317
- Sponsor's protocol ID
- 2026-KY020-01
- Acronym
- PD TIS
- Status last verified
- Mar 2026
- First submitted
- 14 Mar 2026
- Last updated
- 24 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared to protect the privacy of the patients and because the data is currently being used for institutional research and future academic publications.
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanism of Temporal Interference Stimulation on Brain Networks and Its Long-term Clinical Efficacy in Parkinson's Disease
- ClinicalTrials.gov ID
- NCT07480317
- Acronym / sponsor ID
- PD TIS / 2026-KY020-01
- Conditions
- PARKINSON DISEASE (Disorder)
- Keywords
- Temporal Interference Stimulation (TIS), Functional Magnetic Resonance Imaging (fMRI), Non-invasive Brain Stimulation (NIBS), Neuromodulation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Jiangsu Province Nanjing Brain HospitalUniversity, hospital or other
- Study start
- 20 Mar 2026 (estimated)
- Primary completion
- 31 Aug 2026 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 18 Mar 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.
Parkinson's disease (PD) is a neurodegenerative disorder characterized by motor dysfunction. While deep brain stimulation (DBS) is effective, its invasive nature limits its application in early-stage patients. Temporal interference stimulation (TIS) is a novel non-invasive technique that can target deep brain structures like the globus pallidus internus (GPi) by using high-frequency electric fields.
This study aims to evaluate the clinical value and underlying mechanisms of TIS in PD patients. The research is divided into two phases: Phase A investigates the immediate regulatory effects of 130 Hz and 40 Hz TIS on brain networks using concurrent fMRI-TIS. Phase B is a randomized, double-blind, sham-controlled trial to assess the long-term efficacy and safety of a 2-week TIS intervention on both motor and non-motor symptoms. The results will help clarify how TIS modulates deep brain networks and its potential as a non-invasive therapy for PD.
Detailed description
This study employs a two-phase design to systematically investigate the effects of Temporal Interference Stimulation (TIS) on Parkinson's Disease (PD).
Phase A: Acute fMRI Mechanism Study (n=15) In this crossover study, participants will undergo concurrent fMRI-TIS sessions. Two frequency envelopes will be tested: 130 Hz (to mimic DBS inhibitory effects) and 40 Hz (for gamma entrainment). The fMRI protocol follows an 8-20-8 minute design: 8 minutes of baseline, 20 minutes of concurrent stimulation, and 8 minutes of post-stimulation scan . Individualized electric field modeling based on high-resolution 3D-T1 MRI will be used to target the right GPi. Acute motor changes will be assessed using the MDS-UPDRS-III scale.
Phase B: Long-term Efficacy RCT (n=60) Participants will be randomly assigned to one of three parallel groups: 130 Hz TIS, 40 Hz TIS, or Sham stimulation. The intervention consists of 30-minute daily sessions for 2 weeks (10 sessions total).
Active Groups: TIS targeting the right GPi with individualized electrode configurations.
Sham Group: 20-second ramp-up and ramp-down to mimic skin sensation without continuous stimulation.
Clinical assessments including motor function (MDS-UPDRS), cognition (MoCA), mood (HAMD/HAMA), and sleep (PDSS-2) will be conducted at baseline, after the 2-week intervention, and at a 1-month follow-up . Long-term neuroplasticity will also be evaluated using multi-modal MRI post-intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- This study follows a two-phase design: Phase A is a randomized crossover mechanism study (n=15). Phase B is a 3-arm parallel-group, randomized, double-blind efficacy study (n=60).
| Arm | Type | Receives |
|---|---|---|
| 130 Hz TIS Group | Experimental | Device: Temporal Interference Stimulation (130 Hz)Participants receive active Temporal Interference Stimulation (TIS) with a 130 Hz envelope frequency targeting the right globus pallidus internus (GPi). |
| 40 Hz TIS Group | Experimental | Device: Temporal Interference Stimulation (40 Hz)Participants receive active TIS with a 40 Hz envelope frequency targeting the right GPi. |
| Sham Group | Sham comparator | Device: Sham Temporal Interference StimulationParticipants receive sham stimulation targeting the right GPi. |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosed with Parkinson's Disease according to the Movement Disorder Society (MDS) clinical diagnostic criteria.
- Hoehn \& Yahr Stage I-III (mild to moderate severity).
- Aged 45 to 65 years.
- Right-handed. Stable medication regimen for at least 1 hour before Phase A fMRI sessions and agreement to maintain a stable dosage during the 2-week Phase B intervention (unless clinically necessary).
- Able to provide informed consent by the participant or a legal guardian.
Key exclusion criteria (4 listed)
- MRI contraindications, such as implanted DBS electrodes, cardiac pacemakers, or other metal implants.
- Significant cognitive impairment (MoCA score < 24) or severe psychiatric symptoms.
- History of epilepsy or structural brain lesions, including severe cerebral atrophy or cerebrovascular disease.
- Severe head tremors that would interfere with MRI scanning quality.
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 |
|---|---|---|
| Temporal Interference Stimulation (130 Hz)High-frequency sinewave currents (carrier frequency: 2000 Hz and 2130 Hz) are delivered via two pairs of scalp electrodes. The current intensity is 2-4 mA (individualized). In Phase B, stimulation lasts 30 minutes daily for 2 weeks (10 sessions). | Device | 130 Hz TIS Group |
| Temporal Interference Stimulation (40 Hz)High-frequency sinewave currents (carrier frequency: 2000 Hz and 2040 Hz) are delivered via two pairs of scalp electrodes. Parameters are identical to the 130 Hz group except for the envelope frequency. | Device | 40 Hz TIS Group |
| Sham Temporal Interference StimulationThe device provides only a 20-second ramp-up and 20-second ramp-down of current to mimic the skin sensation of active stimulation, without continuous therapeutic stimulation. | Device | Sham Group |
Primary outcome
Change from Baseline in Movement Disorder Society-Unified Parkinson's Disease Rating Scale Part III (MDS-UPDRS-III) total score.
Time frame: Baseline, 2 weeks (immediately after the 10th intervention session), and 1 month (follow-up).
The MDS-UPDRS Part III is a clinician-rated scale used to assess the motor signs of Parkinson's disease. It includes 18 items (33 scores total), with each item ranging from 0 (normal) to 4 (severe). The total score ranges from 0 to 132, where higher scores represent greater motor impairment.
1 secondary outcome
Changes in Brain Network Functional Connectivity and Amplitude of Low-frequency Fluctuations (ALFF).
Time frame: Baseline, 20 minutes (during concurrent TIS), and 8 minutes (immediately post-stimulation) for Phase A ; Baseline and 2 weeks for Phase B.
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 24 Mar 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared to protect the privacy of the patients and because the data is currently being used for institutional research and future academic publications.
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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 Temporal Interference Stimulation (130 Hz) and Temporal Interference Stimulation (40 Hz) in people with PARKINSON DISEASE (Disorder), run by Jiangsu Province Nanjing Brain 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 5 inclusion and 4 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 24 Mar 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 Weiguo Liu, MD, PhD (86-13914725569, wgliunbh@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in Movement Disorder Society-Unified Parkinson's Disease Rating Scale Part III (MDS-UPDRS-III) total score. (time frame: Baseline, 2 weeks (immediately after the 10th intervention session), and 1 month (follow-up).). 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 24 Mar 2026.