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ParkinsonismNCT07176091

Clinical Efficacy of Intermittent Theta Burst Transcranial Magnetic Stimulation With Different Modes on Parkinson's Disease

A study testing High-dose iTBS treatment group and Low-dose iTBS treatment group in people with Parkinsonism and Transcranial Magnetic Stimilation, run by Second Affiliated Hospital of Soochow University 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

TMS regulates cortical excitability through electromagnetic induction, with low-frequency stimulation suppressing and high-frequency stimulation enhancing excitability. Building on theta-gamma coupling, iTBS induces broader improvements in functional brain connectivity within a shorter stimulation period, particularly… Read more about this study

Who is it for?
Ages 40 to 80 years
What is being tested?
High-dose iTBS treatment group and Low-dose iTBS treatment group
Type of treatment
Surgery or procedure
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
90 participants
Where
1 siteChina
Study dates
1 Jan 2025to 1 Jun 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 40 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Aged 40-80 years; ② Diagnosis of idiopathic Parkinson's disease meeting the MDS Clinical Diagnostic Criteria for Parkinson's disease (2015 edition), with a disease duration of at least 3 years and Hoehn \& Yahr stage < 4;
  • Stable use of anti-parkinsonian medication for 2 weeks prior to the study and throughout the entire study period, with no dosage adjustments; ④ Concurrently meeting the diagnostic criteria for Parkinson's disease-related pain, with a frequency of at least 3 times per week and duration of at least 3 months; Numerical Rating Scale (NRS) score ≥ 3; ⑤ Passing the TMS Safety Screening Questionnaire (TSSQ);
  • Passing the MRI Safety Screening Questionnaire (MSSQ); Exclusion Criteria
  • Patients with other diseases that may affect peripheral nerve sensation, including but not limited to diabetes, herpes infection, stroke, or spinal cord disorders;
  • Patients with comorbid severe depression or psychiatric disorders;
  • Presence of severe cognitive impairment, defined as a Mini-Mental State Examination (MMSE) score ≤ 9;
  • Patients with concurrent intracranial organic lesions or a history of traumatic brain injury; ⑤ Patients with severe organic diseases involving the heart, liver, kidneys, or other vital organs; ⑥ Patients unable to undergo cranial MRI examination or TMS treatment due to claustrophobia, presence of implanted devices such as pacemakers, history of epilepsy, or other contraindications.
  • Providing written informed consent.

Who cannot join

None listed.

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

  • The Second Affiliated Hospital of Soochow University

    Suzhou, Jiangsu, 215000

Other trials in China

About this study

TMS regulates cortical excitability through electromagnetic induction, with low-frequency stimulation suppressing and high-frequency stimulation enhancing excitability. Building on theta-gamma coupling, iTBS induces broader improvements in functional brain connectivity within a shorter stimulation period, particularly by significantly reducing abnormal variability in the prefrontal and parietal regions, demonstrating superior neuromodulatory efficiency and network remodeling capacity. This study aims to compare the symptomatic effects of different iTBS protocols on Parkinson's disease, optimize stimulation parameters, and evaluate safety, while also analyzing the time-dependent trends of therapeutic efficacy through 1- and 3-month follow-ups.

Read the detailed description

Transcranial magnetic stimulation, as a neuromodulatory strategy, has received increasing attention in the treatment of Parkinson's disease, demonstrating the ability to improve both motor and non-motor symptoms. Its mechanism is based on electromagnetic induction, using time-varying magnetic fields to modulate cortical neuronal activity. The effects of TMS are frequency-dependent: low-frequency stimulation (≤1 Hz) typically inhibits cortical excitability, resembling long-term depression, while high-frequency stimulation (≥10 Hz) enhances cortical excitability, analogous to long-term potentiation. Building on the mechanism of theta-gamma coupling, theta burst stimulation was developed by embedding high-frequency bursts within a theta rhythm, enabling efficient induction of LTP- and LTD-like effects. Among TBS protocols, intermittent TBS has been shown to exert clear modulatory effects on the motor cortex. Compared with 10 Hz repetitive TMS, iTBS induces broader improvements in functional connectivity across brain regions within a shorter stimulation period, particularly by significantly reducing abnormal variability in the prefrontal and parietal regions, indicating greater neuromodulatory efficiency and network remodeling capacity.

In this study, the iTBS protocol is applied based on the "Stanford Accelerated Intelligent Neuromodulation Therapy" (SAINT) approach. Patients are randomly assigned to one of three groups: a high-dose treatment group, a low-dose treatment group, or a sham stimulation group. Clinical scales are used to evaluate whether different modes of intermittent theta-burst transcranial magnetic stimulation improve motor and non-motor symptoms (particularly pain) in patients with Parkinson's disease. In addition, functional magnetic resonance imaging and electroencephalography are performed before and after treatment to explore the effects of different iTBS protocols on brain network activity and functional connectivity.

Being tested
High-dose iTBS treatment group, Low-dose iTBS treatment group, Sham stimulation group
Medical subject headings
Parkinsonian Disorders

What participants receive

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

  • High-dose iTBS treatment groupProcedure or surgery

    Also called The group treated with tDCS, The group treated with rTMS

    The stimulation intensity is 80% of the resting motor threshold (RMT), with an intra-burst frequency of 50 Hz and an inter-burst frequency of 5 Hz. Each train lasts 2 seconds, followed by an 8-second inter-train interval, delivering 1,800 pulses per session. The session is repeated after a 30-minute interval, with a total of 5 sessions per day (amounting to 9,000 pulses daily). Stimulation is administered for 5 consecutive days, resulting in a total of 45,000 pulses.

  • Low-dose iTBS treatment groupProcedure or surgery

    The stimulation intensity is 80% of the resting motor threshold (RMT), with an intra-burst frequency of 50 Hz and an inter-burst frequency of 5 Hz. Each train lasts 2 seconds, followed by an 8-second inter-train interval, delivering 1,800 pulses per session. Stimulation is administered once daily (1,800 pulses per day) for 5 consecutive days, resulting in a total of 9,000 pulses.

  • Sham stimulation groupProcedure or surgery

    The intervention procedure is identical to that of active stimulation, with the sole difference being the use of a specific sham coil. This sham coil has the same appearance as the active coil but is specially modified to produce no magnetic field, generating only vibration and sound.

Study groups in NCT07176091
Study groupRoleWhat they receive
High-dose iTBS treatment groupExperimentalHigh-dose iTBS, 5 sessions per day for 5 consecutive days.
Receives: Procedure: High-dose iTBS treatment group
Low-dose iTBS treatment groupExperimentalConventional-dose iTBS, once daily for 5 consecutive days.
Receives: Procedure: Low-dose iTBS treatment group
Sham stimulation groupSham comparatorAdminister sham stimulation
Receives: Procedure: Sham stimulation group

What is being measured

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

  1. Assessment with the KPPS

    King's PD Pain Scale (KPPS) includes 14 items rating the severity and frequency of pain, each item scored by severity (0-3) multiplied by frequency (0-4), resulting in a subscore of 0 to 12, with a total possible score range from 0 to 168. Higher scores indicate greater symptom severities and more serious influence.

    Measured: at baseline, on day 1 after treatment, and at 1 month and 3 months after treatment

  2. Assessment with the MKPPS

    Modified King's PD Pain Scale (MKPPS)，the modified version which is more suitable for Chinese people, combined with Ford's pain subtypes basing on the original. It covers five main domains, including 16 items, each item scored by severity (0-3) multiplied by frequency (0-4), resulting in a total possible score range from 0 to 192. Higher scores indicate greater symptom severities and more serious influence.

    Measured: at baseline, on day 1 after treatment, and at 1 month and 3 months after treatment

  3. Change in Pain Intensity Scores (VAS)

    VAS, a 0-10 numeric rating scale with 0= no pain and 10=maximal pain. Higher scores indicate greater symptom severities and more serious influence.

    Measured: at baseline, on day 1 after treatment, and at 1 month and 3 months after treatment

Secondary outcomes (11)

  1. Changes in MDS-UPDRS I

    The participants will be evaluated in their "ON" medication states. The scales used to assess non-motor symptoms included parts I (ranging from 0 to 52) and II (ranging from 0 to 52) of the MDS-UPDRS, with higher scores indicating more severe symptoms

    Measured: at baseline, on day 1 after treatment, and at 1 month and 3 months after treatment

  2. Change in MDS-UPDRS II

    The participants will be evaluated in their "ON" medication states. The scales used to assess non-motor symptoms included parts I (ranging from 0 to 52) and II (ranging from 0 to 52) of the MDS-UPDRS, with higher scores indicating more severe symptoms.

    Measured: at baseline, on day 1 after treatment, and at 1 month and 3 months after treatment

  3. Change in MDS-UPDRS III

    The participants will be evaluated in their "ON" medication states. The scales used to assess motor symptoms included parts III (ranging from 0 to 132) and IV (ranging from 0 to 24) of the MDS-UPDRS, with higher scores indicating more severe symptoms.

    Measured: at baseline, on day 1 after treatment, and at 1 month and 3 months after treatment

  4. Changes in PD Depression Score

    The depression score (ranging from 0 to 76 with higher scores indicating more severe depression) from the 24 items Hamilton Depression Scale (HAMD).

    Measured: at baseline, on day 1 after treatment, and at 1 month and 3 months after treatment

  5. Changes in PD Anxiety Score

    The anxiety score (ranging from 0 to 60 with higher scores indicating more severe anxiety) from the 14 items Hamilton Anxiety Scale (HAMA).

    Measured: at baseline, on day 1 after treatment, and at 1 month and 3 months after treatment

  6. Changes in PD Autonomic Symptoms Score

    The Scale for Outcomes in Parkinson's disease for Autonomic Symptoms (SCOUP-AUT, maximal score 67, with higher scores indicating higher autonomic nervous system dysfunction).

    Measured: at baseline, on day 1 after treatment, and at 1 month and 3 months after treatment

  7. Changes in PD Sleep Problem Score

    The sleep problem index (from 0 to 68 with higher scores indicating more severe sleep problem) from the PD Sleep Scale-2 (PDSS-2).

    Measured: at baseline, on day 1 after treatment, and at 1 month and 3 months after treatment

  8. Changes in PD Daytime Sleepiness Score

    The daytime sleepiness will be assessed by the Epworth Sleeping Scale (ESS), maximal score 24, with higher scores indicating more severe symptoms.

    Measured: at baseline, on day 1 after treatment, and at 1 month and 3 months after treatment

  9. Changes in PD Quality of Life Score

    We will also assess change in quality of life from the Parkinson's Disease Questionnaire-39 (PDQ-39), ranging from 0 to 156 with higher scores indicating more serious influence.

    Measured: at baseline, on day 1 after treatment, and at 1 month and 3 months after treatment

  10. Electroencephalography

    The EEG examination room should be suitably arranged, kept quiet, and free from unnecessary personnel moving around, especially near the patient. Patients are instructed to wash their hair before the examination, avoid fasting, understand the precautions, and remain relaxed. Patients are asked to keep their eyes closed, stay awake, breathe calmly, sit comfortably in a chair, and keep their head still without falling asleep. The EEG cap should be fitted with appropriate tightness, with scalp impedance maintained below 20 kΩ. Earplugs are worn to minimize external interference. EEG signals are recorded using a 128-channel EEG acquisition system (Neuracle, NSH0128, China) and a 64-channel EEG cap (Greentek, Wuhan, China), with a bandpass filter of 0.1-100 Hz and a sampling rate of 1 kHz. Continuous recording is performed for at least 15 minutes. EEG data are collected at time points T0 and T1 between approximately 8:00 AM and 11:00 AM to avoid deviations due to diurnal variations within

    Measured: The day before treatment and the first day after treatment completion.

  11. Functional magnetic resonance imaging

    Functional magnetic resonance imaging (fMRI) of the brain was performed using a Philips Ingenia Elition 3.0T MRI scanner in the Department of Radiology, Suzhou Blue Cross Brain Hospital, Jiangsu Province, China. During the MRI scan, patients lay quietly in a supine position with eyes closed, without limb movement, and with both upper extremities fixed. A standard 8-channel phase-array head coil was used. Subjects were placed in a supine position and immobilized using a standard plastic face mask and soft padding to restrict motion. Conventional SE sequence T1WI was used to acquire anatomical images [repetition time (TR) = 500 ms, echo time (TE) = 16 ms, matrix = 256 × 256, slice thickness = 5 mm, interslice gap = 1 mm, number of slices = 24].

    Fluid attenuated inversion recovery (FLAIR) T2WI was performed to exclude patients with intracranial lesions [TR = 8000 ms, TE = 125 ms, inversion time (TI) = 2000 ms, number of excitations (NEX) = 1.00, field of view (FOV) = 24 cm × 18 cm, matr

    Measured: The day before treatment and the first day after treatment completion.

Timeline

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

  1. First posted16 Sep 2025
  2. Study start1 Jan 2025
  3. Primary completion1 Mar 2027 (estimated)
  4. Study completion1 Jun 2027 (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
Parallel groups
Model description
Patients will be randomised into three groups-high-dose iTBS, low-dose iTBS, and sham stimulation-at a 1:1:1 ratio.
Masking
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
90 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07176091
Sponsor's protocol ID
LK2025027
Status last verified
Feb 2026
First submitted
10 Aug 2025
Last updated
13 Feb 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Liu S, Yang S, Wang C, Li J, Wang L. Effects of two types of repetitive transcranial magnetic stimulation on brain network in Parkinson's disease. NPJ Parkinsons Dis. 2025 Jul 1;11(1):191. doi: 10.1038/s41531-025-01054-4.

    PubMed 40593930

  • Huang YZ, Edwards MJ, Rounis E, Bhatia KP, Rothwell JC. Theta burst stimulation of the human motor cortex. Neuron. 2005 Jan 20;45(2):201-6. doi: 10.1016/j.neuron.2004.12.033.

    PubMed 15664172

  • Galanis C, Hananeia N, Lenz M, Vasheghani Farahani M, Jedlicka P, Vlachos A. Repetitive magnetic stimulation induces plasticity of excitatory synapses through cooperative pre- and postsynaptic activity. Brain Stimul. 2025 Sep-Oct;18(5):1641-1650. doi: 10.1016/j.brs.2025.08.019. Epub 2025 Aug 23.

    PubMed 40850522

  • Armstrong MJ, Okun MS. Diagnosis and Treatment of Parkinson Disease: A Review. JAMA. 2020 Feb 11;323(6):548-560. doi: 10.1001/jama.2019.22360.

    PubMed 32044947

Questions about this trial

What is this clinical trial studying?

A study testing High-dose iTBS treatment group and Low-dose iTBS treatment group in people with Parkinsonism and Transcranial Magnetic Stimilation, run by Second Affiliated Hospital of Soochow 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 8 inclusion and 0 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 Feb 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?

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?

Assessment with the KPPS (time frame: at baseline, on day 1 after treatment, and at 1 month and 3 months after treatment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07176091, which also lists 4 linked publications.

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 Feb 2026.

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