Parkinson DiseaseNCT06415682

The Efficacy and Mechanism of SMA+M1 Repetitive Transcranial Magnetic Stimulation on Freezing of Gait in PD

A study testing SMA+M1 Transcranial Magnetic Stimulation and M1 Transcranial Magnetic Stimulation in people with Parkinson Disease, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 40 to 80 yearsHealthy volunteers can take part
Conditions the study is for: Parkinson Disease
What is being tested?: SMA+M1 Transcranial Magnetic Stimulation and M1 Transcranial Magnetic Stimulation
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 64 participants
Where: 1 siteChina
Study dates: 8 Oct 2024to 31 Mar 2025
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 to 80 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

aged between 40-80 years;
diagnosis of idiopathic Parkinson's disease (PD) according to the Movement Disorder Society clinical diagnostic criteria;
patients were stable on dopaminergic treatment for at least 3 months;
Item 3 of the Freezing of Gait Questionnaire(FOG-Q) scored ≥1;
Patients experienced FOG during an interview.

Who cannot join

comorbidities of major neurologic diseases other than PD;
suffer from musculoskeletal disorders that could have interfered with their ability to walk;
presence of contraindications for transcranial magnetic stimulation (TMS) and magnetic resonance imaging (MRI);
marked tremor interfered with TMS detection;
previously receiving any kinds of TMS interventions;
severe cognitive impairment making cooperation impossible [Mini Mental State Examination (MMSE) < 24];
were unable to walk independently during the OFF state.

Trial locations and contacts

1 site in 1 country.

China1 site

The First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, 210029

Other trials in China

About this study

This study is a double-blinded randomized study examining the efficacy of the double-site (M1+SMA) repetitive transcranial magnetic stimulation on Freezing of Gait (FOG) in patients with Parkinson's disease. The investigators hypothesize that treatment using magnetic stimulation on double site (including M1-LL and SMA) will improve FOG and gait symptoms in patients with Parkinson's disease.

Read the detailed description

Patients in the double-site group underwent ten sessions of double-site high frequency rTMS over the bilateral primary motor cortex of the lower leg and supplementary motor area, whereas patients in the single-site group underwent ten sessions of single-site active magnetic stimulation with high frequency rTMS over the bilateral primary motor cortex of the lower leg. In addition, patients in the sham group underwent 10 sessions of sham rTMS on bilateral primary motor cortex of the lower leg. Assessments of FOG severity, gait, motor symptoms, excitability of cortex motor (using transcranial magnetic stimulation), plasma indicators and multimodal magnetic resonance were performed three times: at baseline, one day post intervention, one month post intervention.

Conditions: Parkinson Disease
Being tested: SMA+M1 Transcranial Magnetic Stimulation, M1 Transcranial Magnetic Stimulation, Sham Transcranial Magnetic Stimulation
Keywords: Parkinson's disease, gait symptoms, freezing of gait, TMS, neural mechanism
Medical subject headings: Parkinson Disease

What participants receive

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

SMA+M1 Transcranial Magnetic StimulationDevice
The M1 stimulation session consisted 40 trains of 10-Hz rTMS with the protocol of 5s train session and 25s intertrain intervals. There were 4000 pulses per day for M1-LL (unilateral stimulation 2000 pulses). For SMA stimulation, a 5s burst of 10Hz rTMS was repeated 20 times (1000 pulse, 20 minutes' duration).
Patients in the Experimental group underwent ten sessions of double-site high frequency rTMS over the bilateral primary motor cortex (M1) of the lower leg and supplementary motor area (SMA).
M1 Transcranial Magnetic StimulationDevice
The M1 stimulation session consisted 40 trains of 10-Hz rTMS with the protocol of 5s train session and 25s intertrain intervals. There were 4000 pulses per day for M1-LL (unilateral stimulation 2000 pulses). Patients in the Active Comparator group underwent ten sessions of single-site active magnetic stimulation with high frequency rTMS over the bilateral M1 of the lower leg.
Sham Transcranial Magnetic StimulationDevice
Patients in the Sham Comparator group underwent 10 sessions of double sham rTMS on M1 of the lower leg.

Study groups in NCT06415682
Study group	Role	What they receive
double-site high frequency rTMS over the bilateral M1 of the lower leg and SMA	Experimental	Patients in the Experimental group underwent ten sessions of double-site high frequency rTMS over the bilateral M1 of the lower leg and SMA. Receives: Device: SMA+M1 Transcranial Magnetic Stimulation
single-site high frequency rTMS over the bilateral M1 of the lower leg	Active comparator	Patients in the Active Comparator group underwent ten sessions of single-site active magnetic stimulation with high frequency rTMS over the bilateral M1 of the lower leg. Receives: Device: M1 Transcranial Magnetic Stimulation
sham magnetic stimulation on the bilateral M1 of the lower leg	Sham comparator	Patients in the Sham Comparator group underwent ten sessions of double sham rTMS on the bilateral M1 of the lower leg. Receives: Device: Sham Transcranial Magnetic Stimulation

What is being measured

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

Changes of Freezing of Gait severity
The Freezing of Gait questionnaire will be used to quantify the frequency and severity of FOG. The score will be compared to the baseline. The minimum and maximum values of the FOGQ are 0 and 24. A higher score means a worse outcome. The differences in FOGQ scores before and after treatment can be used to evaluate the effect of TMS treatment.
Measured: Assessed at baseline, one day post intervention, one month post intervention

Secondary outcomes (7)

Freezing of Gait severity assessment
The New Freezing of Gait questionnaire will be used to quantify the frequency and severity of FOG. The score will be compared to the baseline. The minimum and maximum values of the NFOGQ are 0 and 28. A higher score means a worse outcome. The differences in NFOGQ scores before and after treatment can be used to evaluate the effect of TMS treatment.
Measured: Assessed at baseline, one day post intervention, one month post intervention
Changes of Movement Disorder Society Unified Parkinson's disease rating scale part III (MDS-UPDRS-III)
The measure mainly reflects the overall severity of Parkinson's disease motor symptoms and non-motor symptoms. The minimum value is 0 and the maximum value is 132. A higher score means a worse outcome. The score will be compared to the baseline. The differences in MDS-UPDRS III part scores before and after treatment can be used to evaluate the effect of TMS treatment.
Measured: Assessed at baseline, one day post intervention, one month post intervention
Changes of Gait speed
Gait speed (m/s) was evaluated at baseline, one day post intervention, one month post intervention using a portable Inertial Measurement Unit system during a 5-m timed Up-and-Go (TUG) test. The differences in gait speed before and after treatment can be used to evaluate the effect of TMS treatment.
Measured: Assessed at baseline, one day post intervention, one month post intervention
Changes of Stride length
Stride length (cm) was evaluated at baseline, one day post intervention, one month post intervention using a portable Inertial Measurement Unit system during a 5-m timed Up-and-Go (TUG) test. The differences in stride length before and after treatment can be used to evaluate the effect of TMS treatment.
Measured: Assessed at baseline, one day post intervention, one month post intervention
Changes in Short-interval intracortical inhibition (SICI), intracortical facilitation (ICF) and short-interval intracortical facilitation (SICF)
Short-interval intracortical inhibition (SICI), intracortical facilitation (ICF) and short-interval intracortical facilitation (SICF) are conducted by TMS devices to assess the cortical excitation and inhibition. SICI was assessed with a subthreshold conditioning stimulus (80% RMT) and a supra-threshold test stimulus (1 mV MEP) with 2ms, 3ms, 4ms interstimulus interval between conditioning and test stimuli. ICF was assessed with a subthreshold conditioning stimulus (80% RMT) and a supra-threshold test stimulus (1 mV MEP) with 10, 12, 15 ms interstimulus interval between conditioning and test stimuli. For SICF, a subthreshold first stimulus (S1) intensity was set at 1 mV and a subsequent suprathreshold second stimulus (S2) intensity was set at RMT. Interstimulus intervals were 1.0 to 5.0 milliseconds with increments of 0.5 millisecond.The differences in SICI, ICF and SICF before and after treatment can be used to evaluate the effect of TMS treatment.
Measured: Assessed at baseline, one day post intervention
Changes in functional connectivity in the brain cortex
The functional connectivity in the brain cortex will be recorded by functional MRI. The differences in brain regions' functional connectivity before and after treatment can be used to evaluate the effect of TMS treatment.
Measured: Assessed at baseline, one day post intervention
Changes in brain structure
Studying the brain structure among groups. The differences in brain microstructure before and after treatment can be used to evaluate the effect of TMS treatment.
Measured: Assessed at baseline, one day post intervention

Timeline

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

8 Oct 202431 Mar 2025

First posted16 May 2024
Study start8 Oct 2024
Primary completion21 Mar 2025
Study completion31 Mar 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
More trials run by The First Affiliated Hospital with Nanjing Medical UniversityThe sponsor's other registered studies.
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: 64 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06415682
Sponsor's protocol ID: 2024-SR-290
Status last verified: Apr 2025
First submitted: 5 May 2024
Last updated: 1 May 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 1 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Efficacy and Mechanism of SMA+M1 Repetitive Transcranial Magnetic Stimulation on Freezing of Gait in PD
ClinicalTrials.gov ID: NCT06415682
Acronym / sponsor ID: 2024-SR-290
Conditions: Parkinson Disease
Keywords: Parkinson's disease, gait symptoms, freezing of gait, TMS, neural mechanism
Study type: Interventional
Recruitment status: Completed
Enrolment: 64 participants (actual)
Lead sponsor: The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
Study start: 8 Oct 2024 (actual)
Primary completion: 21 Mar 2025 (actual)
Study completion: 31 Mar 2025 (actual)
First posted: 16 May 2024 (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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
double-site high frequency rTMS over the bilateral M1 of the lower leg and SMA	Experimental	Device: SMA+M1 Transcranial Magnetic StimulationPatients in the Experimental group underwent ten sessions of double-site high frequency rTMS over the bilateral M1 of the lower leg and SMA.
single-site high frequency rTMS over the bilateral M1 of the lower leg	Active comparator	Device: M1 Transcranial Magnetic StimulationPatients in the Active Comparator group underwent ten sessions of single-site active magnetic stimulation with high frequency rTMS over the bilateral M1 of the lower leg.
sham magnetic stimulation on the bilateral M1 of the lower leg	Sham comparator	Device: Sham Transcranial Magnetic StimulationPatients in the Sham Comparator group underwent ten sessions of double sham rTMS on the bilateral M1 of the lower leg.

Who may qualify

Ages: 40 to 80 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

aged between 40-80 years;
diagnosis of idiopathic Parkinson's disease (PD) according to the Movement Disorder Society clinical diagnostic criteria;
patients were stable on dopaminergic treatment for at least 3 months;
Item 3 of the Freezing of Gait Questionnaire(FOG-Q) scored ≥1;
Patients experienced FOG during an interview.

Key exclusion criteria (7 listed)

comorbidities of major neurologic diseases other than PD;
suffer from musculoskeletal disorders that could have interfered with their ability to walk;
presence of contraindications for transcranial magnetic stimulation (TMS) and magnetic resonance imaging (MRI);
marked tremor interfered with TMS detection;
previously receiving any kinds of TMS interventions;

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
SMA+M1 Transcranial Magnetic StimulationThe M1 stimulation session consisted 40 trains of 10-Hz rTMS with the protocol of 5s train session and 25s intertrain intervals. There were 4000 pulses per day for M1-LL (unilateral stimulation 2000 pulses). For SMA stimulation, a 5s burst of 10Hz rTMS was repeated 20 times (1000 pulse, 20 minutes' duration). Patients in the Experimental group underwent ten sessions of double-site high frequency rTMS over the bilateral primary motor cortex (M1) of the lower leg and supplementary motor area (SMA).	Device	double-site high frequency rTMS over the bilateral M1 of the lower leg and SMA
M1 Transcranial Magnetic StimulationThe M1 stimulation session consisted 40 trains of 10-Hz rTMS with the protocol of 5s train session and 25s intertrain intervals. There were 4000 pulses per day for M1-LL (unilateral stimulation 2000 pulses). Patients in the Active Comparator group underwent ten sessions of single-site active magnetic stimulation with high frequency rTMS over the bilateral M1 of the lower leg.	Device	single-site high frequency rTMS over the bilateral M1 of the lower leg
Sham Transcranial Magnetic StimulationPatients in the Sham Comparator group underwent 10 sessions of double sham rTMS on M1 of the lower leg.	Device	sham magnetic stimulation on the bilateral M1 of the lower leg

Primary outcome

Changes of Freezing of Gait severity
Time frame: Assessed at baseline, one day post intervention, one month post intervention
The Freezing of Gait questionnaire will be used to quantify the frequency and severity of FOG. The score will be compared to the baseline. The minimum and maximum values of the FOGQ are 0 and 24. A higher score means a worse outcome. The differences in FOGQ scores before and after treatment can be used to evaluate the effect of TMS treatment.

7 secondary outcomes

Freezing of Gait severity assessment
Time frame: Assessed at baseline, one day post intervention, one month post intervention
Changes of Movement Disorder Society Unified Parkinson's disease rating scale part III (MDS-UPDRS-III)
Time frame: Assessed at baseline, one day post intervention, one month post intervention
Changes of Gait speed
Time frame: Assessed at baseline, one day post intervention, one month post intervention
Changes of Stride length
Time frame: Assessed at baseline, one day post intervention, one month post intervention
Changes in Short-interval intracortical inhibition (SICI), intracortical facilitation (ICF) and short-interval intracortical facilitation (SICF)
Time frame: Assessed at baseline, one day post intervention
Changes in functional connectivity in the brain cortex
Time frame: Assessed at baseline, one day post intervention
Changes in brain structure
Time frame: Assessed at baseline, one day post intervention

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 1 May 2025.
Individual participant dataSharing planned: No

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Enrolling by invitationObservational study
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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.

Kezhong Zhang principal investigator

The First Affiliated Hospital with Nanjing Medical University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 7 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 1 May 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?

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?

Changes of Freezing of Gait severity (time frame: Assessed at baseline, one day post intervention, one month post intervention). 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 NCT06415682.

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 1 May 2025.