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

NCT07176091 | Enrolling By Invitation

• 1 other identifier: LK2025027
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Transcranial Magnetic Stimilation; Intermittent Theta Burst Stimulation; Electroencephalography; Neuromodulation; Parkinsonism; Primary Motor Cortex

Outcome Measures

Primary Outcomes (3)

• 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.

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

• 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.

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

• 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.

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

Secondary Outcomes (11)

• Changes in MDS-UPDRS I

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

• Change in MDS-UPDRS II

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

• Change in MDS-UPDRS III

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

• Changes in PD Depression Score

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

• Changes in PD Anxiety Score

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

Study Arms (3)

High-dose iTBS treatment group

EXPERIMENTAL

High-dose iTBS, 5 sessions per day for 5 consecutive days.

Procedure: High-dose iTBS treatment group

Low-dose iTBS treatment group

EXPERIMENTAL

Conventional-dose iTBS, once daily for 5 consecutive days.

Procedure: Low-dose iTBS treatment group

Sham stimulation group

SHAM COMPARATOR

Administer sham stimulation

Procedure: Sham stimulation group

Interventions

High-dose iTBS treatment group PROCEDURE

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.

Also known as: The group treated with tDCS, The group treated with rTMS

High-dose iTBS treatment group

Low-dose iTBS treatment group PROCEDURE

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.

Low-dose iTBS treatment group

Sham stimulation group PROCEDURE

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.

Sham stimulation group

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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);

You may not qualify if:

• 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.

Sponsors & Collaborators

• Second Affiliated Hospital of Soochow University: lead

Study Sites (1)

The Second Affiliated Hospital of Soochow University

Suzhou, Jiangsu, 215000, China

Location

Related Publications (4)

• 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.

  PMID: 40593930 BACKGROUND

• 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.

  PMID: 15664172 BACKGROUND

• 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.

  PMID: 40850522 BACKGROUND

• 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.

  PMID: 32044947 BACKGROUND

MeSH Terms

Conditions

Parkinsonian Disorders

Interventions

Transcranial Direct Current Stimulation; Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques; Magnetic Field Therapy

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: The figure-of-eight coils used for active or sham stimulation are similar, including the emitted sound and the scalp tapping sensation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Patients will be randomised into three groups-high-dose iTBS, low-dose iTBS, and sham stimulation-at a 1:1:1 ratio.

Study Record Dates

• First Submitted: August 10, 2025
• First Posted: September 16, 2025
• Study Start: January 1, 2025
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: February 13, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)