Parkinson s DiseaseNCT07572903
The Efficacy and Safety of Temporal Interference Stimulation on Motor Symptoms of Parkinson's Disease
A study testing Temporal Interference Stimulation in people with Parkinson s Disease, run by The First Affiliated Hospital of Anhui Medical University at 1 site in China.
Trial summary
This study aimed to evaluate the clinical efficacy and safety of temporal interference stimulation (TIS) targeting different targets in patients with Parkinson's disease (PD), and to investigate the associated neurophysiological mechanisms. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Parkinson s Disease
- What is being tested?
- Temporal Interference Stimulation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 96 participants
- Where
- 1 siteChina
- Study dates
- 6 May 2026to 1 Aug 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >= 40 years;
- Meet the diagnostic criteria for primary Parkinson's disease (MDS Parkinson's Disease Diagnostic Criteria (2015 Edition));
- No medication adjustment in the 4 weeks before and during each stimulation;
- MDS-UPDRS III score >= 8 points, Hoehn-Yahr score 1-4 points
Who cannot join
- Focal brain injury or severe leukoencephalopathy (Fazekas grade 3 or above) on previous head MRI/CT scans;
- Various secondary Parkinson's syndromes (vascular Parkinson's syndrome, drug-induced Parkinson's syndrome, etc.);
- Severe craniocerebral trauma, cranial surgery or deep brain stimulation treatment;
- Ferromagnetic implants in the body, such as cochlear implants, cardiac pacemakers, etc.;
- A history of epilepsy, unexplained loss of consciousness, or taking anticonvulsant drugs for epileptic seizures;
- Diagnosed with neuropsychiatric diseases other than Parkinson's disease;
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- A history of drug abuse or drug use;
- Participated in any clinical trial in the past 3 months;
- Pregnant/lactating women or subjects (including men) who plan to have children within 6 months;
- Other situations that the researchers consider unsuitable for inclusion.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui
About this study
Official title: The Efficacy and Safety of Temporal Interference Stimulation on Motor Symptoms of Parkinson's Disease: A Three-arm, Randomized, Double-blind, Parallel-controlled Study
This study aimed to evaluate the clinical efficacy and safety of temporal interference stimulation (TIS) targeting different targets in patients with Parkinson's disease (PD), and to investigate the associated neurophysiological mechanisms. A three-arm, randomised, double-blind, parallel-group design was employed, consisting of a right globus pallidus internus (GPi) stimulation group, a right subthalamic nucleus (STN) stimulation group, and a sham stimulation group. PD patients in the OFF-medication state (≥12 hours after the last dopaminergic dose) were randomly assigned to receive either active TIS targeting the GPi or STN, or sham stimulation, with each session lasting 30 minutes. Clinical symptom assessments were conducted before and immediately after the intervention, and safety was monitored throughout by the research team.
- Conditions
- Parkinson s Disease
- Being tested
- Temporal Interference Stimulation
- Keywords
- Parkinson s Disease, Temporal Interference Stimulation
- 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 StimulationOther
Temporal Interference Stimulation
| Study group | Role | What they receive |
|---|---|---|
| GPi group | Experimental | Not described Receives: Other: Temporal Interference Stimulation |
| STN group | Experimental | Not described Receives: Other: Temporal Interference Stimulation |
| Sham group | Sham comparator | Not described Receives: Other: Temporal Interference Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
The part III of MDS-Unified Parkinson's Disease Rating Scale
Measured: Baseline，Immediately after a single stimulation
Secondary outcomes (7)
Hoehn-Yahr Stage Scale
Measured: Baseline，Immediately after a single stimulation
3-Meter Timed Up and Go Test
Measured: Baseline，Immediately after a single stimulation
10-meter walking test
Measured: Baseline，Immediately after a single stimulation
Upper and lower limb alternation
Measured: Baseline，Immediately after a single stimulation
Clinical Global Impression
CGI comprehensively quantifies the severity of a patient's illness and the net benefit of treatment by assessing disease severity (CGI-S), overall improvement (CGI-I), and the balance between efficacy and side effects (Efficacy Index EI).
Measured: Baseline，Immediately after a single stimulation
Resting-state electroencephalogram（rsEEG）
Measured: Baseline，Immediately after a single stimulation
Transcranial Magnetic Stimulation-Electroencephalography（TMS-EEG）
Transcranial magnetic stimulation (TMS) combined with electroencephalography (EEG) is a technique used to assess cortical excitability and causal network connectivity.
Measured: Baseline，Immediately after a single stimulation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2026
- Study start6 May 2026
- Primary completion16 Jul 2026
- Study completion1 Aug 2026
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.
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital of Anhui Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Panpan Hu, MD, The First Affiliated Hospital of Anhui Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07572903
- Sponsor's protocol ID
- AHMU-single TIS-PD
- Status last verified
- Jul 2026
- First submitted
- 27 Apr 2026
- Last updated
- 11 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety of Temporal Interference Stimulation on Motor Symptoms of Parkinson's Disease: A Three-arm, Randomized, Double-blind, Parallel-controlled Study
- ClinicalTrials.gov ID
- NCT07572903
- Acronym / sponsor ID
- AHMU-single TIS-PD
- Conditions
- Parkinson s Disease
- Keywords
- Parkinson s Disease, Temporal Interference Stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- The First Affiliated Hospital of Anhui Medical UniversityUniversity, hospital or other
- Study start
- 6 May 2026 (actual)
- Primary completion
- 16 Jul 2026 (actual)
- Study completion
- 1 Aug 2026 (actual)
- First posted
- 7 May 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 aimed to evaluate the clinical efficacy and safety of temporal interference stimulation (TIS) targeting different targets in patients with Parkinson's disease (PD), and to investigate the associated neurophysiological mechanisms. A three-arm, randomised, double-blind, parallel-group design was employed, consisting of a right globus pallidus internus (GPi) stimulation group, a right subthalamic nucleus (STN) stimulation group, and a sham stimulation group. PD patients in the OFF-medication state (≥12 hours after the last dopaminergic dose) were randomly assigned to receive either active TIS targeting the GPi or STN, or sham stimulation, with each session lasting 30 minutes. Clinical symptom assessments were conducted before and immediately after the intervention, and safety was monitored throughout by the research team.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| GPi group | Experimental | Other: Temporal Interference Stimulation |
| STN group | Experimental | Other: Temporal Interference Stimulation |
| Sham group | Sham comparator | Other: Temporal Interference Stimulation |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age >= 40 years;
- Meet the diagnostic criteria for primary Parkinson's disease (MDS Parkinson's Disease Diagnostic Criteria (2015 Edition));
- No medication adjustment in the 4 weeks before and during each stimulation;
- MDS-UPDRS III score >= 8 points, Hoehn-Yahr score 1-4 points
Key exclusion criteria (10 listed)
- Focal brain injury or severe leukoencephalopathy (Fazekas grade 3 or above) on previous head MRI/CT scans;
- Various secondary Parkinson's syndromes (vascular Parkinson's syndrome, drug-induced Parkinson's syndrome, etc.);
- Severe craniocerebral trauma, cranial surgery or deep brain stimulation treatment;
- Ferromagnetic implants in the body, such as cochlear implants, cardiac pacemakers, etc.;
- A history of epilepsy, unexplained loss of consciousness, or taking anticonvulsant drugs for epileptic seizures;
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 StimulationTemporal Interference Stimulation | Other | GPi group, STN group, Sham group |
Primary outcome
The part III of MDS-Unified Parkinson's Disease Rating Scale
Time frame: Baseline，Immediately after a single stimulation
7 secondary outcomes
Hoehn-Yahr Stage Scale
Time frame: Baseline，Immediately after a single stimulation
3-Meter Timed Up and Go Test
Time frame: Baseline，Immediately after a single stimulation
10-meter walking test
Time frame: Baseline，Immediately after a single stimulation
Upper and lower limb alternation
Time frame: Baseline，Immediately after a single stimulation
Clinical Global Impression
Time frame: Baseline，Immediately after a single stimulation
Resting-state electroencephalogram（rsEEG）
Time frame: Baseline，Immediately after a single stimulation
Transcranial Magnetic Stimulation-Electroencephalography（TMS-EEG）
Time frame: Baseline，Immediately after a single stimulation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2026.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 in people with Parkinson s Disease, run by The First Affiliated Hospital of Anhui Medical University 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 4 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: finished, as of the sponsor's last update on 11 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The part III of MDS-Unified Parkinson's Disease Rating Scale (time frame: Baseline，Immediately after a single 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 11 Aug 2026.