Parkinson Disease (PD)PD-FOG-TMSNCT07731841
Transcranial Magnetic Stimulation for Freezing of Gait in Parkinson's Disease
A study testing Primary Motor Cortex Transcranial Magnetic Stimulation, Spinal Cord Magnetic Stimulation and SMA TMS in people with Parkinson Disease (PD), run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
Trial summary
This study evaluated transcranial magnetic stimulation (TMS) for freezing of gait in patients with Parkinson's disease. Participants with Parkinson's disease and freezing of gait received conventional TMS protocols, and their clinical, gait, and neurophysiological outcomes were assessed. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Parkinson Disease (PD)
- What is being tested?
- Primary Motor Cortex Transcranial Magnetic Stimulation, Spinal Cord Magnetic Stimulation and SMA TMS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2021to 23 Jun 2026
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- (1) a score of ≥ 1 on MDS-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Item 13 or FOGQ Item 3, with freezing episodes during gait initiation, turning, or navigating narrow spaces confirmed by two independent investigators; (2) a stable antiparkinsonian medication regimen for at least four weeks before enrollment; (3) right-handedness; (4) age ≥ 40 years; (5) no current use of antidepressants, anxiolytics, or antipsychotic agents. Antiparkinsonian medications and their dosages remained unchanged throughout the study.
Who cannot join
- (1) personal or family history of atypical parkinsonian syndromes, including multiple system atrophy, progressive supranuclear palsy, corticobasal degeneration, Wilson's disease, and vascular parkinsonism; (2) coexisting movement disorders or other neurodegenerative conditions; (3) gait-impairing disorders such as primary progressive freezing of gait; (4) impaired consciousness, or visual, auditory, or language deficits that precluded full assessment; (5) severe systemic diseases, including cardiopulmonary disorders, hepatic or renal insufficiency, malignancies, and hematologic or autoimmune diseases; (6) prior cranial surgery or deep brain stimulation (DBS); (7) pregnancy; (8) history of epilepsy; (9) severe cognitive impairment with a Mini-Mental State Examination (MMSE) score below 24; and (10) other contraindications to TMS.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital with Nanjing Medical University
Nanjing, Jiangsu, 210029
About this study
Official title: Mechanisms of Differential Response to Transcranial Magnetic Stimulation in Freezing of Gait in Parkinson's Disease and Cerebellar Stimulation Intervention for Treatment-Resistant Patients
This study evaluated transcranial magnetic stimulation (TMS) for freezing of gait in patients with Parkinson's disease. Participants with Parkinson's disease and freezing of gait received conventional TMS protocols, and their clinical, gait, and neurophysiological outcomes were assessed. Patients who did not achieve sufficient improvement after conventional TMS were further treated with a combined primary motor cortex and cerebellar stimulation protocol. The study aimed to identify factors associated with differential response to conventional TMS and to explore whether cerebellar stimulation could improve symptoms in treatment-resistant patients.
- Conditions
- Parkinson Disease (PD)
- Being tested
- Primary Motor Cortex Transcranial Magnetic Stimulation, Spinal Cord Magnetic Stimulation, SMA TMS, Cerebellar Intermittent Theta-Burst Stimulation
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Primary Motor Cortex Transcranial Magnetic StimulationDevice
Bilateral lower-limb primary motor cortex stimulation was delivered at 10 Hz and 90% of resting motor threshold, with 2000 pulses per hemisphere. Treatment was administered once daily for five consecutive days per week over two weeks.
Spinal Cord Magnetic StimulationDevice
Transcutaneous spinal magnetic stimulation was delivered over the T10-T12 segment at 1 Hz, with 1500 pulses. Stimulation intensity was adjusted to produce visible lower-limb muscle contraction.
SMA TMSDevice
Supplementary motor area stimulation was delivered at 10 Hz and 90% of resting motor threshold, with 1000 pulses. Treatment was administered as an add-on protocol combined with bilateral lower-limb primary motor cortex stimulation.
Cerebellar Intermittent Theta-Burst StimulationDevice
Bilateral cerebellar intermittent theta-burst stimulation was delivered using 50-Hz triplets at 5 Hz, with 2-second trains every 10 seconds and a total of 2700 pulses over 15 minutes. This intervention was administered to patients who were treatment-resistant to conventional TMS.
| Study group | Role | What they receive |
|---|---|---|
| M1 Stimulation | Experimental | Participants received bilateral lower-limb primary motor cortex stimulation at 10 Hz and 90% of resting motor threshold, with 2000 pulses per hemisphere. Treatment was administered once daily for five consecutive days per week over two weeks. Receives: Device: Primary Motor Cortex Transcranial Magnetic Stimulation |
| M1 Plus Spinal Cord Stimulation | Experimental | Participants received bilateral lower-limb primary motor cortex stimulation combined with transcutaneous spinal magnetic stimulation over the T10-T12 segment. Primary motor cortex stimulation was delivered at 10 Hz and 90% of resting motor threshold, with 2000 pulses per hemisphere. Spinal cord stimulation was delivered at 1 Hz with 1500 pulses. Treatment was administered once daily for five consecutive days per week over two weeks. Receives: Device: Primary Motor Cortex Transcranial Magnetic Stimulation; Device: Spinal Cord Magnetic Stimulation |
| M1 Plus SMA Stimulation | Experimental | Participants received bilateral lower-limb primary motor cortex stimulation combined with supplementary motor area stimulation. Primary motor cortex stimulation was delivered at 10 Hz and 90% of resting motor threshold, with 2000 pulses per hemisphere. Supplementary motor area stimulation was delivered at 10 Hz and 90% of resting motor threshold, with 1000 pulses. Treatment was administered once daily for five consecutive days per week over two weeks. Receives: Device: Primary Motor Cortex Transcranial Magnetic Stimulation; Device: SMA TMS |
| M1 Plus Cerebellar Stimulation | Experimental | Treatment-resistant participants received bilateral lower-limb primary motor cortex stimulation combined with bilateral cerebellar intermittent theta-burst stimulation. Primary motor cortex stimulation parameters were unchanged. Cerebellar intermittent theta-burst stimulation was delivered bilaterally using 50-Hz triplets at 5 Hz, with 2-second trains every 10 seconds and a total of 2700 pulses over 15 minutes. Receives: Device: Primary Motor Cortex Transcranial Magnetic Stimulation; Device: Cerebellar Intermittent Theta-Burst Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Freezing of Gait Questionnaire Improvement Rate
The improvement rate of the Freezing of Gait Questionnaire was calculated as [(pre-treatment FOGQ score at baseline - post-treatment FOGQ score at one-month follow-up) / pre-treatment FOGQ score at baseline] × 100%. Participants with an improvement rate of at least 30% were classified as treatment responsive.
Measured: Baseline and 1 month after treatment
Secondary outcomes (2)
Unified Parkinson's Disease Rating Scale Part III Score
Motor symptoms were assessed using the Unified Parkinson's Disease Rating Scale Part III.
Measured: Baseline, within 24 hours after treatment, and 1 month after treatment
Upper-Limb Short-Interval Intracortical Inhibition
Upper-limb short-interval intracortical inhibition was assessed using paired-pulse transcranial magnetic stimulation and expressed as the conditioned/unconditioned motor evoked potential amplitude ratio.
Measured: Baseline and within 24 hours after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2026
- Study start1 Sep 2021
- Primary completion30 Dec 2025
- Study completion23 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson Disease (PD)Studies 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
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07731841
- Sponsor's protocol ID
- 2021-SRFA-020-02
- Acronym
- PD-FOG-TMS
- Status last verified
- Jul 2026
- First submitted
- 23 Jul 2026
- Last updated
- 28 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared because the informed consent and ethics approval did not include permission for public sharing of individual-level clinical and neurophysiological data.
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanisms of Differential Response to Transcranial Magnetic Stimulation in Freezing of Gait in Parkinson's Disease and Cerebellar Stimulation Intervention for Treatment-Resistant Patients
- ClinicalTrials.gov ID
- NCT07731841
- Acronym / sponsor ID
- PD-FOG-TMS / 2021-SRFA-020-02
- Conditions
- Parkinson Disease (PD)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 30 Dec 2025 (actual)
- Study completion
- 23 Jun 2026 (actual)
- First posted
- 28 Jul 2026 (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 evaluated transcranial magnetic stimulation (TMS) for freezing of gait in patients with Parkinson's disease. Participants with Parkinson's disease and freezing of gait received conventional TMS protocols, and their clinical, gait, and neurophysiological outcomes were assessed. Patients who did not achieve sufficient improvement after conventional TMS were further treated with a combined primary motor cortex and cerebellar stimulation protocol. The study aimed to identify factors associated with differential response to conventional TMS and to explore whether cerebellar stimulation could improve symptoms in treatment-resistant patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| M1 Stimulation | Experimental | Device: Primary Motor Cortex Transcranial Magnetic StimulationParticipants received bilateral lower-limb primary motor cortex stimulation at 10 Hz and 90% of resting motor threshold, with 2000 pulses per hemisphere. Treatment was administered once daily for five consecutive days per week over two weeks. |
| M1 Plus Spinal Cord Stimulation | Experimental | Device: Primary Motor Cortex Transcranial Magnetic Stimulation, Device: Spinal Cord Magnetic StimulationParticipants received bilateral lower-limb primary motor cortex stimulation combined with transcutaneous spinal magnetic stimulation over the T10-T12 segment. Primary motor cortex stimulation was delivered at 10 Hz and 90% of resting motor threshold, with 2000 pulses per hemisphere. Spinal cord stimulation was delivered at 1 Hz with 1500 pulses. Treatment was administered once daily for five consecutive days per week over two weeks. |
| M1 Plus SMA Stimulation | Experimental | Device: Primary Motor Cortex Transcranial Magnetic Stimulation, Device: SMA TMSParticipants received bilateral lower-limb primary motor cortex stimulation combined with supplementary motor area stimulation. Primary motor cortex stimulation was delivered at 10 Hz and 90% of resting motor threshold, with 2000 pulses per hemisphere. Supplementary motor area stimulation was delivered at 10 Hz and 90% of resting motor threshold, with 1000 pulses. Treatment was administered once daily for five consecutive days per week over two weeks. |
| M1 Plus Cerebellar Stimulation | Experimental | Device: Primary Motor Cortex Transcranial Magnetic Stimulation, Device: Cerebellar Intermittent Theta-Burst StimulationTreatment-resistant participants received bilateral lower-limb primary motor cortex stimulation combined with bilateral cerebellar intermittent theta-burst stimulation. Primary motor cortex stimulation parameters were unchanged. Cerebellar intermittent theta-burst stimulation was delivered bilaterally using 50-Hz triplets at 5 Hz, with 2-second trains every 10 seconds and a total of 2700 pulses over 15 minutes. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- (1) a score of ≥ 1 on MDS-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Item 13 or FOGQ Item 3, with freezing episodes during gait initiation, turning, or navigating narrow spaces confirmed by two independent investigators; (2) a stable antiparkinsonian medication regimen for at least four weeks before enrollment; (3) right-handedness; (4) age ≥ 40 years; (5) no current use of antidepressants, anxiolytics, or antipsychotic agents. Antiparkinsonian medications and their dosages remained unchanged throughout the study.
Key exclusion criteria (1 listed)
- (1) personal or family history of atypical parkinsonian syndromes, including multiple system atrophy, progressive supranuclear palsy, corticobasal degeneration, Wilson's disease, and vascular parkinsonism; (2) coexisting movement disorders or other neurodegenerative conditions; (3) gait-impairing disorders such as primary progressive freezing of gait; (4) impaired consciousness, or visual, auditory, or language deficits that precluded full assessment; (5) severe systemic diseases, including cardiopulmonary disorders, hepatic or renal insufficiency, malignancies, and hematologic or autoimmune diseases; (6) prior cranial surgery or deep brain stimulation (DBS); (7) pregnancy; (8) history of epilepsy; (9) severe cognitive impairment with a Mini-Mental State Examination (MMSE) score below 24; and (10) other contraindications to TMS.
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 |
|---|---|---|
| Primary Motor Cortex Transcranial Magnetic StimulationBilateral lower-limb primary motor cortex stimulation was delivered at 10 Hz and 90% of resting motor threshold, with 2000 pulses per hemisphere. Treatment was administered once daily for five consecutive days per week over two weeks. | Device | M1 Plus Cerebellar Stimulation, M1 Plus SMA Stimulation, M1 Plus Spinal Cord Stimulation, M1 Stimulation |
| Spinal Cord Magnetic StimulationTranscutaneous spinal magnetic stimulation was delivered over the T10-T12 segment at 1 Hz, with 1500 pulses. Stimulation intensity was adjusted to produce visible lower-limb muscle contraction. | Device | M1 Plus Spinal Cord Stimulation |
| SMA TMSSupplementary motor area stimulation was delivered at 10 Hz and 90% of resting motor threshold, with 1000 pulses. Treatment was administered as an add-on protocol combined with bilateral lower-limb primary motor cortex stimulation. | Device | M1 Plus SMA Stimulation |
| Cerebellar Intermittent Theta-Burst StimulationBilateral cerebellar intermittent theta-burst stimulation was delivered using 50-Hz triplets at 5 Hz, with 2-second trains every 10 seconds and a total of 2700 pulses over 15 minutes. This intervention was administered to patients who were treatment-resistant to conventional TMS. | Device | M1 Plus Cerebellar Stimulation |
Primary outcome
Freezing of Gait Questionnaire Improvement Rate
Time frame: Baseline and 1 month after treatment
The improvement rate of the Freezing of Gait Questionnaire was calculated as [(pre-treatment FOGQ score at baseline - post-treatment FOGQ score at one-month follow-up) / pre-treatment FOGQ score at baseline] × 100%. Participants with an improvement rate of at least 30% were classified as treatment responsive.
2 secondary outcomes
Unified Parkinson's Disease Rating Scale Part III Score
Time frame: Baseline, within 24 hours after treatment, and 1 month after treatment
Upper-Limb Short-Interval Intracortical Inhibition
Time frame: Baseline and within 24 hours after treatment
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 28 Jul 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared because the informed consent and ethics approval did not include permission for public sharing of individual-level clinical and neurophysiological data.
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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.
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 Primary Motor Cortex Transcranial Magnetic Stimulation, Spinal Cord Magnetic Stimulation and SMA TMS in people with Parkinson Disease (PD), 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 1 inclusion and 1 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 28 Jul 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. 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?
Freezing of Gait Questionnaire Improvement Rate (time frame: Baseline and 1 month after treatment). 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 28 Jul 2026.