Temporal Interference StimulationNCT06931483
The Efficacy and Safety of Transcranial Temporal Interference Stimulation (tTIS) Targeting the Right Globus Pallidus Internus (GPi) for Motor Symptoms in Patients With PD
A study testing Transcranial temporal interference stimulation (tTIS) in people with Temporal Interference Stimulation and Parkinson's Disease, run by Yanghua Tian at 1 site in China.
Trial summary
To demonstrate that intervention targeting the right globus pallidus internus (GPi) using transcranial temporal interference stimulation can improve motor symptoms in patients with Parkinson's disease. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Temporal Interference Stimulation, Parkinson's Disease, the Right Globus Pallidus Internus
- What is being tested?
- Transcranial temporal interference stimulation (tTIS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2024to 31 Dec 2025
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Meeting the diagnostic criteria for Parkinson's disease in China (2016 version), diagnosed as PD by two neurologists;
- Hoehn-Yahr stage 1.5-4;
- Age > 50 years old;
- No signs of moderate to severe depression: Beck Depression Inventory-II (BDI-II) score < 20;
- No signs of dementia: Mini-Mental State Examination (MMSE) score > 21;
- No change in medication regimen in the four weeks prior to enrollment;
- Right-handed.
Who cannot join
- History of other neuropsychiatric disorders;
- History of alcohol or drug abuse;
- Previous history of TMS or traditional TES treatment;
- Presence of non-MRI compatible metal implants in the body, such as deep brain stimulation devices, pacemakers or stents.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
To demonstrate that intervention targeting the right globus pallidus internus (GPi) using transcranial temporal interference stimulation can improve motor symptoms in patients with Parkinson's disease.
Read the detailed description
Each of patients received either 30-minute or sham tTIS of the right GPi. Before and immediately after the stimulation, participants completed the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS-III) in the "medication-on" state to assess the motor symptoms. MDS-UPDRS, HAMA and HAMD were assessed on intervention Day 1, Day 10 and 1-month follow-up and clinical efficacy was evaluated by comparing the scale scores before and after the intervention.
- Conditions
- Temporal Interference Stimulation, Parkinson's Disease, the Right Globus Pallidus Internus, Motor Symptoms
- Being tested
- Transcranial temporal interference stimulation (tTIS), Sham transcranial temporal interference stimulation (tTIS)
- Keywords
- temporal interference stimulation, Parkinson's Disease, motor symptoms, the right globus pallidus internus
- 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
The total stimulation duration was 30 minutes, including a 30-second current ramp-up at the beginning and a 30-second ramp-down at the end.
Sham transcranial temporal interference stimulation (tTIS)Device
Sham stimulation had only 30 seconds of current ramping-up and ramping-down at the beginning and end of the stimulation, respectively, to simulate the sensation of actual stimulation.
| Study group | Role | What they receive |
|---|---|---|
| real stimulation | Active comparator | Participants will receive active tTIS for 10 days. Receives: Device: Transcranial temporal interference stimulation (tTIS) |
| sham stimulation | Sham comparator | Participants will receive sham tTIS for 10 days. Receives: Device: Sham transcranial temporal interference stimulation (tTIS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
To assess the motor symptoms, participants completed the official Chinese version of MDS-UPDRS.The MDS-UPDRS-III includes 33 items, with scores ranging from 0 to 132. The subscores of MDS-UPDRS-III, including (1) rigidity (item 3.3), (2) bradykinesia (items 3.2, 3.4, 3.8, and 3.14), (3) tremor (items 3.15-3.18), and (4) axial signs (items 3.9-3.13), were also used as the secondary outcomes in the following analyses.
Measured: On intervention Day 1, Day 10 and 1-month follow-up.
Secondary outcomes (2)
emotional symptoms assessed by the HAMA
The HAMA is a 14-item scale to measure 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 less anxiety symptoms.
Measured: on intervention Day 1, Day 10 and 1-month follow-up
emotional symptoms assessed by the HAMD
The HAMD is a clinic ian-administered depression assessment and consists of 17 items with a total score range from 0 to 54. A higher score indicates a worse outcome.
Measured: On intervention Day 1, Day 10 and 1-month follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2025
- Study start1 Sep 2024
- Primary completion30 Sep 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Temporal Interference StimulationStudies 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yanghua Tian
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yanghua Tian, The Second Hospital of Anhui Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06931483
- Sponsor's protocol ID
- AHMU-tTIS-PD
- Status last verified
- Apr 2025
- First submitted
- 9 Apr 2025
- Last updated
- 17 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety of Transcranial Temporal Interference Stimulation (tTIS) Targeting the Right Globus Pallidus Internus (GPi) for Motor Symptoms in Patients With PD
- ClinicalTrials.gov ID
- NCT06931483
- Acronym / sponsor ID
- AHMU-tTIS-PD
- Conditions
- Temporal Interference Stimulation, Parkinson's Disease, the Right Globus Pallidus Internus, Motor Symptoms
- Keywords
- temporal interference stimulation, Parkinson's Disease, motor symptoms, the right globus pallidus internus
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Yanghua TianUniversity, hospital or other
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 17 Apr 2025 (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.
To demonstrate that intervention targeting the right globus pallidus internus (GPi) using transcranial temporal interference stimulation can improve motor symptoms in patients with Parkinson's disease.
Detailed description
Each of patients received either 30-minute or sham tTIS of the right GPi. Before and immediately after the stimulation, participants completed the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS-III) in the "medication-on" state to assess the motor symptoms. MDS-UPDRS, HAMA and HAMD were assessed on intervention Day 1, Day 10 and 1-month follow-up and clinical efficacy was evaluated by comparing the scale scores before and after the intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| real stimulation | Active comparator | Device: Transcranial temporal interference stimulation (tTIS)Participants will receive active tTIS for 10 days. |
| sham stimulation | Sham comparator | Device: Sham transcranial temporal interference stimulation (tTIS)Participants will receive sham tTIS for 10 days. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Meeting the diagnostic criteria for Parkinson's disease in China (2016 version), diagnosed as PD by two neurologists;
- Hoehn-Yahr stage 1.5-4;
- Age > 50 years old;
- No signs of moderate to severe depression: Beck Depression Inventory-II (BDI-II) score < 20;
- No signs of dementia: Mini-Mental State Examination (MMSE) score > 21;
Key exclusion criteria (4 listed)
- History of other neuropsychiatric disorders;
- History of alcohol or drug abuse;
- Previous history of TMS or traditional TES treatment;
- Presence of non-MRI compatible metal implants in the body, such as deep brain stimulation devices, pacemakers or stents.
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)The total stimulation duration was 30 minutes, including a 30-second current ramp-up at the beginning and a 30-second ramp-down at the end. | Device | real stimulation |
| Sham transcranial temporal interference stimulation (tTIS)Sham stimulation had only 30 seconds of current ramping-up and ramping-down at the beginning and end of the stimulation, respectively, to simulate the sensation of actual stimulation. | Device | sham stimulation |
Primary outcome
Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
Time frame: On intervention Day 1, Day 10 and 1-month follow-up.
To assess the motor symptoms, participants completed the official Chinese version of MDS-UPDRS.The MDS-UPDRS-III includes 33 items, with scores ranging from 0 to 132. The subscores of MDS-UPDRS-III, including (1) rigidity (item 3.3), (2) bradykinesia (items 3.2, 3.4, 3.8, and 3.14), (3) tremor (items 3.15-3.18), and (4) axial signs (items 3.9-3.13), were also used as the secondary outcomes in the following analyses.
2 secondary outcomes
emotional symptoms assessed by the HAMA
Time frame: on intervention Day 1, Day 10 and 1-month follow-up
emotional symptoms assessed by the HAMD
Time frame: On intervention Day 1, Day 10 and 1-month follow-up.
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 17 Apr 2025.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial temporal interference stimulation (tTIS) in people with Temporal Interference Stimulation and Parkinson's Disease, run by Yanghua Tian 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 7 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: enrolling by invitation, as of the sponsor's last update on 17 Apr 2025. 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?
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?
Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) (time frame: On intervention Day 1, Day 10 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 17 Apr 2025.