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.
Trial summary
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. Read more about this study
- 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
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 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.
- 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)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kezhong Zhang, Principal investigator, The First Affiliated Hospital with Nanjing Medical University
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
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.
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.
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.
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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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?
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.
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?
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; AzTrials last refreshed its copy on 8 Nov 2026.