Transcranial Magnetic StimulationNCT05192759
Effect of Theta-Burst Transcranial Magnetic Stimulation (TBS) for Freezing of Gait
A study testing Transcranial Magnetic Stimulation in people with Transcranial Magnetic Stimulation and Freezing of Gait, run by Anhui Medical University at 1 site in China.
Trial summary
To investigate the treatment effect of Theta-burst Transcranial Magnetic Stimulation (TBS) on patients with freezing of gait (FOG) and the underlying neural mechanism. Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Transcranial Magnetic Stimulation, Freezing of Gait
- What is being tested?
- Transcranial Magnetic Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 22 Nov 2021to 30 Dec 2028
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosis of FOG with expertise in movement disorders.
- the score of item 3 of the FOG questionnaire ≥1.
- ongoing treatment with a stable dose of any medication for 2 months.
- 40 years of age or older.
Who cannot join
- a history of addiction, psychiatric disorders, or neurological diseases other than PD.
- focal brain lesions on T1-/T2-weighted fluid-attenuated inversion recovery images.
- anti-PD medication adjustments during rTMS treatment.
- history of substance abuse within the past 6 months.
- nonremovable metal objects in or around the head.
- previously received rTMS treatment.
- prior history of seizure or history in first-degree relatives.
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, 1 recruiting
- Recruiting
Cognitive Neuropsychology Lab Anhui Medical University
Hefei, Anhui, 230032
Gong-Jun JI, Ph.D., +8655162923704, jigongjun@163.com
Jinmei Sun, M.S., +8615856381782, sunjinmei0628@163.com
About this study
To investigate the treatment effect of Theta-burst Transcranial Magnetic Stimulation (TBS) on patients with freezing of gait (FOG) and the underlying neural mechanism.
Read the detailed description
This was a open-label clinical trial to assess the efficacy and underlying neural mechanism of TBS among patients with FOG. Forty patients with FOG were treated with TBS for 1 week.
Before the TBS treatment, the Freezing of Gait Questionnaire, the Timed up and go test, the Standing Start 180° Turning Test, the Unified Parkinson's Disease Rating Scale, and the Non-motor Symptom Scale, the Pittsburgh sleep quality index were obtained by a trained investigator to assess baseline severity. The patients had receiving a battery measure of neuropsychological tests(mini-mental state examination, Montreal cognitive assessment, digital span test, verbal fluency test, Hamilton depression/anxiety scale) and magnetic resonance imaging (MRI) scan in multimodalities, electroencephalography (EEG) record and fNIRS.
In the second day after the last treatment, all the tests, MRI 、EEG and fNIRS were reassessed. Patients were instructed to focus their answers on the past 1 week.
The clinical symptom and cognition of participants were followed in one month and two month after the last treatment.
- Being tested
- Transcranial Magnetic Stimulation
- Keywords
- Transcranial Magnetic Stimulation, Freezing of gait
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial Magnetic StimulationDevice
The stimulations were performed by MagStim Rapid2.
| Study group | Role | What they receive |
|---|---|---|
| TBS Group | Experimental | Participants will receive active transcranial magnetic stimulation (TMS) daily for 1 week Receives: Device: Transcranial Magnetic Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Standing-Start 180° Turn Test (SS-180)
The participants walk for a distance of five meters from a sitting position and come back to the chair after turning 180° around a traffic cone in a 0.7 m × 0.7 m target box.The time and number of steps during the 180° turn (SS180) are measured.
Measured: changes from baseline to 1-week post-treatment
Secondary outcomes (7)
The timed up and go test (TUG)
The participants walk for a distance of five meters from a sitting position and come back to the chair after turning 180° around a traffic cone in a 0.7 m × 0.7 m target box .The time and number of steps during the whole course are measured.
Measured: changes from baseline to 1-week post-treatment
The Freezing of Gait Questionnaire (FOGQ)
This is an very common clinical motor estimating scale for evaluating FOG symptoms with 6 items and 24' in total. Higher scores indicate worse symptoms.
Measured: changes from baseline to 1-week post-treatment
Unified Parkinson's Disease Rating Scale III (UPDRSIII)
This is an very common clinical motor estimating scale, 14 items and 108' in total. Higher scores indicate worse symptoms.
Measured: changes from baseline to 1-week post-treatment
Non-motor symptoms questionnaire
This is a very common clinical scale with nine domains (30 items). Each item was scored on "severity" range from 1 to 3 and "frequency" range from 1 to 4. Higher scores indicate worse symptoms.
Measured: changes from baseline to 1-week post-treatment
HAMD (Hamilton Depression Scale)
This scale was compiled by Hamilton in 1960, is the most common clinical to assess Depression Scale. In this study, 17 versions were selected, and there were 17 questions. The subjects were assessed for their depression in the past week. Each question scored between 0 and 4 points.Higher scores indicate more depressive symptoms.
Measured: changes from baseline to 1-week post-treatment
HAMA (Hamilton Anxiety Scale)
This scale was compiled by Hamilton in 1959.It was one of the most commonly used scales in psychiatric clinic, including 14 items. It is often used in clinical diagnosis and degree classification of anxiety disorder. The subjects were assessed for their anxiety in the past week. Each question scored between 0 and 4 points. The higher the score, the more symptoms of anxiety.
Measured: changes from baseline to 1-week post-treatment
Pittsburgh sleep quality index (PSQI)
This scale was developed by Dr. Buysse et al., a psychiatrist at the University of Pittsburgh in 1989. The scale is suitable for the evaluation of sleep quality in patients with sleep disorders and mental disorders, as well as for the evaluation of sleep quality in general.Each question scored between 0 and 3 points.The higher the score, the worse sleep quality.
Measured: changes from baseline to 1-week post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2022
- Study start22 Nov 2021
- Primary completion30 Dec 2028 (estimated)
- Study completion30 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Transcranial Magnetic StimulationStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Anhui Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, WANG KAI, Anhui Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05192759
- Sponsor's protocol ID
- AHMU-TMS-FOG
- Status last verified
- Nov 2025
- First submitted
- 3 Jan 2022
- Last updated
- 19 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yu L, Han J, Chen X, Hu L, Wang M, Zhu M, Cheng J, Liu P, Fang L, Li Y, Wu J, Zhao X, Sun J, Ji GJ, Wang K, Ye R, Hu P. Regional-specific structural and functional changes of posterior cerebellar vermis across different stages of Parkinson's disease with gait dysfunction. NPJ Parkinsons Dis. 2025 Jul 12;11(1):208. doi: 10.1038/s41531-025-01065-1.
PubMed 40651960
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Theta-Burst Transcranial Magnetic Stimulation (TBS) for Freezing of Gait
- ClinicalTrials.gov ID
- NCT05192759
- Acronym / sponsor ID
- AHMU-TMS-FOG
- Keywords
- Transcranial Magnetic Stimulation, Freezing of gait
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Anhui Medical UniversityUniversity, hospital or other
- Study start
- 22 Nov 2021 (actual)
- Primary completion
- 30 Dec 2028 (estimated)
- Study completion
- 30 Dec 2028 (estimated)
- First posted
- 14 Jan 2022 (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.
To investigate the treatment effect of Theta-burst Transcranial Magnetic Stimulation (TBS) on patients with freezing of gait (FOG) and the underlying neural mechanism.
Detailed description
This was a open-label clinical trial to assess the efficacy and underlying neural mechanism of TBS among patients with FOG. Forty patients with FOG were treated with TBS for 1 week.
Before the TBS treatment, the Freezing of Gait Questionnaire, the Timed up and go test, the Standing Start 180° Turning Test, the Unified Parkinson's Disease Rating Scale, and the Non-motor Symptom Scale, the Pittsburgh sleep quality index were obtained by a trained investigator to assess baseline severity. The patients had receiving a battery measure of neuropsychological tests(mini-mental state examination, Montreal cognitive assessment, digital span test, verbal fluency test, Hamilton depression/anxiety scale) and magnetic resonance imaging (MRI) scan in multimodalities, electroencephalography (EEG) record and fNIRS.
In the second day after the last treatment, all the tests, MRI 、EEG and fNIRS were reassessed. Patients were instructed to focus their answers on the past 1 week.
The clinical symptom and cognition of participants were followed in one month and two month after the last treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TBS Group | Experimental | Device: Transcranial Magnetic StimulationParticipants will receive active transcranial magnetic stimulation (TMS) daily for 1 week |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- diagnosis of FOG with expertise in movement disorders.
- the score of item 3 of the FOG questionnaire ≥1.
- ongoing treatment with a stable dose of any medication for 2 months.
- 40 years of age or older.
Key exclusion criteria (7 listed)
- a history of addiction, psychiatric disorders, or neurological diseases other than PD.
- focal brain lesions on T1-/T2-weighted fluid-attenuated inversion recovery images.
- anti-PD medication adjustments during rTMS treatment.
- history of substance abuse within the past 6 months.
- nonremovable metal objects in or around the head.
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 |
|---|---|---|
| Transcranial Magnetic StimulationThe stimulations were performed by MagStim Rapid2. | Device | TBS Group |
Primary outcome
The Standing-Start 180° Turn Test (SS-180)
Time frame: changes from baseline to 1-week post-treatment
The participants walk for a distance of five meters from a sitting position and come back to the chair after turning 180° around a traffic cone in a 0.7 m × 0.7 m target box.The time and number of steps during the 180° turn (SS180) are measured.
7 secondary outcomes
The timed up and go test (TUG)
Time frame: changes from baseline to 1-week post-treatment
The Freezing of Gait Questionnaire (FOGQ)
Time frame: changes from baseline to 1-week post-treatment
Unified Parkinson's Disease Rating Scale III (UPDRSIII)
Time frame: changes from baseline to 1-week post-treatment
Non-motor symptoms questionnaire
Time frame: changes from baseline to 1-week post-treatment
HAMD (Hamilton Depression Scale)
Time frame: changes from baseline to 1-week post-treatment
HAMA (Hamilton Anxiety Scale)
Time frame: changes from baseline to 1-week post-treatment
Pittsburgh sleep quality index (PSQI)
Time frame: changes from baseline to 1-week post-treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2025.
- Derived from this study: PubMed 40651960Yu L, Han J, Chen X, Hu L, Wang M, Zhu M, Cheng J, Liu P, Fang L, Li Y, Wu J, Zhao X, Sun J, Ji GJ, Wang K, Ye R, Hu P. Regional-specific structural and functional changes of posterior cerebellar vermis across different stages of Parkinson's disease with gait dysfunction. NPJ Parkinsons Dis. 2025 Jul 12;11(1):208. doi: 10.1038/s41531-025-01065-1.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial Magnetic Stimulation in people with Transcranial Magnetic Stimulation and Freezing of Gait, run by Anhui 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 4 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: looking for participants now, as of the sponsor's last update on 19 Nov 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. 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?
Contact Gong-Jun JI, Ph.D. (+8655162923704, jigongjun@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Standing-Start 180° Turn Test (SS-180) (time frame: changes from baseline to 1-week post-treatment). 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 NCT05192759, which also lists 1 linked publication.
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 19 Nov 2025.