Parkinson DiseaseNCT06888778
Efficacy of Deep-coil Based Repetitive Transcranial Magnetic Stimulation in the Treatment of Parkinson's Disease With Freezing of Gait and Its Neural Regulation Mechanism Study of Resting-state Cerebral Blood Flow
A study testing repetitive transcranial magnetic stimulation (rTMS) and Non-stimulation in people with Parkinson Disease and Freezing of Gait, run by Ningbo Medical Center Lihuili Hospital at 1 site in China.
Trial summary
The protocol for repetitive transcranial magnetic stimulation (rTMS) in treating Parkinson's disease (PD) with freezing of gait (FOG) has not yet established an internationally unified standard, and the heterogeneity of treatment parameters is often the main factor leading to significant differences in efficacy. Read more about this study
- Who is it for?
- Ages 45 to 70 years
- Conditions the study is for
- Parkinson Disease, Freezing of Gait
- What is being tested?
- repetitive transcranial magnetic stimulation (rTMS) and Non-stimulation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2023to 1 Dec 2024
- 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 45 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Meeting the clinical diagnostic criteria for Parkinson's disease established by the Movement Disorder Society (MDS) in 2015.
- Aged between 45 and 70 years old, regardless of gender.
- Regularly taking anti - Parkinson's disease medications for a long time (≥3 years), accompanied by freezing of gait, and with poor efficacy of medications;
- A score of ≥24 on the Mini - Mental State Examination (MMSE).
- Signing the informed consent form and being willing to actively cooperate with the treatment.
Who cannot join
- Freezing of gait caused by parkinsonism and parkinson plus syndromes.
- Having a history of central nervous system diseases such as cerebral infarction, cerebral hemorrhage, leukoencephalopathy, and migraine.
- Having been diagnosed with epilepsy or having had epileptic seizures.
- Having undergone craniocerebral surgery, having cerebral aneurysms or arteriovenous malformations, having metal implants in the skull, or having had a cardiac pacemaker implanted.
- Having a history of other mental illnesses or a family history of mental illnesses, such as schizophrenia, bipolar disorder, autism, mental retardation, depression, etc.
- Having received rTMS treatment.
- Severe PD (H\&Y grade ≥ 4).
- Severe organ dysfunction or severe physical diseases.
Trial locations and contacts
1 site in 1 country.
China1 site
Ningbo Medical Center Li Huili Hospital, Ningbo, China
Ningbo, Zhejiang, 315100
About this study
The protocol for repetitive transcranial magnetic stimulation (rTMS) in treating Parkinson's disease (PD) with freezing of gait (FOG) has not yet established an internationally unified standard, and the heterogeneity of treatment parameters is often the main factor leading to significant differences in efficacy. Based on descriptive analyses and existing data from studies with relatively small sample sizes, the current research primarily focuses on unilateral stimulation targets, without exploring the effectiveness of stimulating the bilateral primary motor centers for lower limbs (M1-LL). Moreover, most studies use figure-of-eight coils or circular coils, while deep-coil stimulation may be more effective for M1-LL. There is still a lack of research employing arterial spin labeling (ASL) imaging to explore the neural mechanisms of resting-state cerebral blood flow (CBF) regulation associated with rTMS treatment for FOG.
Therefore, this research project will focus on improving the above - mentioned issues. The high - frequency stimulation of bilateral M1 - LL using a deep - coil (double - cone coil) will be selected. The sample size will be further expanded to evaluate the efficacy of rTMS in treating freezing of gait (FOG). Combined with the three - dimensional arterial spin labeling (3D - ASL) imaging technique, the changes in resting - state cerebral blood flow (CBF) before and after treatment will be analyzed to explore the possible neural mechanisms of rTMS in treating FOG.
Read the detailed description
Magstim rapid 2 transcranial magnetic stimulation instrument was used with double-cone coils, and the stimulation target was bilateral M1-LL. The total stimulation time of each target was 10 minutes, once a day, 5 times a week (5 consecutive working days), and the treatment was continuous for 2 weeks, a total of 10 times.
Stimulus parameter setting:
- True stimulus group: 100% Rest Motor Threshold (RMT), 10Hz, each stimulus lasted 10 seconds, 55 seconds apart, a total of 10 strings. Once a day, each side of the lower extremity region of the primary motor cortex received a total of 1000 pulses.
- In the pseudo-stimulation group, the side of the double-cone coil was placed against the scalp, and the bull 's-eye of the coil was stimulated towards the air. Other treatment parameters were the same as those of true stimulation group.
- Conditions
- Parkinson Disease, Freezing of Gait
- Being tested
- repetitive transcranial magnetic stimulation (rTMS), Non-stimulation
- Keywords
- Parkinson disease, Freezing of Gait, Repetitive Transcranial Magnetic 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.
repetitive transcranial magnetic stimulation (rTMS)Other
rTMS is a non-invasive brain stimulation technique that stimulates specific brain areas through repeated magnetic pulses to treat depression, anxiety and other mental illnesses, and to study brain function.
Non-stimulationOther
participants receive Non-stimulation:The side of the double cone coil is placed against the scalp, and the target of the coil is stimulated in the direction of air.
| Study group | Role | What they receive |
|---|---|---|
| stimulation group | Experimental | participants receive repetitive transcranial magnetic stimulation (rTMS) Receives: Other: repetitive transcranial magnetic stimulation (rTMS) |
| Non-stimulation group | Placebo comparator | participants receive Non-stimulation:The side of the double cone coil is placed against the scalp, and the target of the coil is stimulated in the direction of air. Receives: Other: Non-stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Unified Parkinson's Disease Rating Scale
In this study, Unified Parkinson's Disease Rating Scale(UPDRS) score was used as an assessment tool for PD patients. Four subscales, UPDRS II (0-52 scores), UPDRS III (0-56 scores), UPDRS V (0-5 grades), and UPDRS VI (0-11 grades), were used to assess the condition. The higher the score or grade, the sicker the patient.
Measured: Within 24 hours before treatment, within 24 hours after treatment, and 1 month after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2025
- Study start1 Feb 2023
- Primary completion1 Dec 2024
- Study completion1 Dec 2024
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 Parkinson DiseaseStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ningbo Medical Center Lihuili Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Guangli Ren, Ningbo Medical Center Lihuili Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06888778
- Sponsor's protocol ID
- KY2022PJ280
- Status last verified
- Feb 2025
- First submitted
- 17 Feb 2025
- Last updated
- 4 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rascol O, Brooks DJ, Korczyn AD, De Deyn PP, Clarke CE, Lang AE. A five-year study of the incidence of dyskinesia in patients with early Parkinson's disease who were treated with ropinirole or levodopa. N Engl J Med. 2000 May 18;342(20):1484-91. doi: 10.1056/NEJM200005183422004.
PubMed 10816186
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Deep-coil Based Repetitive Transcranial Magnetic Stimulation in the Treatment of Parkinson's Disease With Freezing of Gait and Its Neural Regulation Mechanism Study of Resting-state Cerebral Blood Flow
- ClinicalTrials.gov ID
- NCT06888778
- Acronym / sponsor ID
- KY2022PJ280
- Conditions
- Parkinson Disease, Freezing of Gait
- Keywords
- Parkinson disease, Freezing of Gait, Repetitive Transcranial Magnetic Stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ningbo Medical Center Lihuili HospitalOther government
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 1 Dec 2024 (actual)
- Study completion
- 1 Dec 2024 (actual)
- First posted
- 21 Mar 2025 (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.
The protocol for repetitive transcranial magnetic stimulation (rTMS) in treating Parkinson's disease (PD) with freezing of gait (FOG) has not yet established an internationally unified standard, and the heterogeneity of treatment parameters is often the main factor leading to significant differences in efficacy. Based on descriptive analyses and existing data from studies with relatively small sample sizes, the current research primarily focuses on unilateral stimulation targets, without exploring the effectiveness of stimulating the bilateral primary motor centers for lower limbs (M1-LL). Moreover, most studies use figure-of-eight coils or circular coils, while deep-coil stimulation may be more effective for M1-LL. There is still a lack of research employing arterial spin labeling (ASL) imaging to explore the neural mechanisms of resting-state cerebral blood flow (CBF) regulation associated with rTMS treatment for FOG.
Therefore, this research project will focus on improving the above - mentioned issues. The high - frequency stimulation of bilateral M1 - LL using a deep - coil (double - cone coil) will be selected. The sample size will be further expanded to evaluate the efficacy of rTMS in treating freezing of gait (FOG). Combined with the three - dimensional arterial spin labeling (3D - ASL) imaging technique, the changes in resting - state cerebral blood flow (CBF) before and after treatment will be analyzed to explore the possible neural mechanisms of rTMS in treating FOG.
Detailed description
Magstim rapid 2 transcranial magnetic stimulation instrument was used with double-cone coils, and the stimulation target was bilateral M1-LL. The total stimulation time of each target was 10 minutes, once a day, 5 times a week (5 consecutive working days), and the treatment was continuous for 2 weeks, a total of 10 times.
Stimulus parameter setting:
- True stimulus group: 100% Rest Motor Threshold (RMT), 10Hz, each stimulus lasted 10 seconds, 55 seconds apart, a total of 10 strings. Once a day, each side of the lower extremity region of the primary motor cortex received a total of 1000 pulses.
- In the pseudo-stimulation group, the side of the double-cone coil was placed against the scalp, and the bull 's-eye of the coil was stimulated towards the air. Other treatment parameters were the same as those of true stimulation group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| stimulation group | Experimental | Other: repetitive transcranial magnetic stimulation (rTMS)participants receive repetitive transcranial magnetic stimulation (rTMS) |
| Non-stimulation group | Placebo comparator | Other: Non-stimulationparticipants receive Non-stimulation:The side of the double cone coil is placed against the scalp, and the target of the coil is stimulated in the direction of air. |
Who may qualify
- Ages
- 45 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Meeting the clinical diagnostic criteria for Parkinson's disease established by the Movement Disorder Society (MDS) in 2015.
- Aged between 45 and 70 years old, regardless of gender.
- Regularly taking anti - Parkinson's disease medications for a long time (≥3 years), accompanied by freezing of gait, and with poor efficacy of medications;
- A score of ≥24 on the Mini - Mental State Examination (MMSE).
- Signing the informed consent form and being willing to actively cooperate with the treatment.
Key exclusion criteria (8 listed)
- Freezing of gait caused by parkinsonism and parkinson plus syndromes.
- Having a history of central nervous system diseases such as cerebral infarction, cerebral hemorrhage, leukoencephalopathy, and migraine.
- Having been diagnosed with epilepsy or having had epileptic seizures.
- Having undergone craniocerebral surgery, having cerebral aneurysms or arteriovenous malformations, having metal implants in the skull, or having had a cardiac pacemaker implanted.
- Having a history of other mental illnesses or a family history of mental illnesses, such as schizophrenia, bipolar disorder, autism, mental retardation, depression, etc.
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 |
|---|---|---|
| repetitive transcranial magnetic stimulation (rTMS)rTMS is a non-invasive brain stimulation technique that stimulates specific brain areas through repeated magnetic pulses to treat depression, anxiety and other mental illnesses, and to study brain function. | Other | stimulation group |
| Non-stimulationparticipants receive Non-stimulation:The side of the double cone coil is placed against the scalp, and the target of the coil is stimulated in the direction of air. | Other | Non-stimulation group |
Primary outcome
Unified Parkinson's Disease Rating Scale
Time frame: Within 24 hours before treatment, within 24 hours after treatment, and 1 month after treatment
In this study, Unified Parkinson's Disease Rating Scale(UPDRS) score was used as an assessment tool for PD patients. Four subscales, UPDRS II (0-52 scores), UPDRS III (0-56 scores), UPDRS V (0-5 grades), and UPDRS VI (0-11 grades), were used to assess the condition. The higher the score or grade, the sicker the patient.
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 4 Apr 2025.
- Background: PubMed 10816186Rascol O, Brooks DJ, Korczyn AD, De Deyn PP, Clarke CE, Lang AE. A five-year study of the incidence of dyskinesia in patients with early Parkinson's disease who were treated with ropinirole or levodopa. N Engl J Med. 2000 May 18;342(20):1484-91. doi: 10.1056/NEJM200005183422004.
- 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.
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 repetitive transcranial magnetic stimulation (rTMS) and Non-stimulation in people with Parkinson Disease and Freezing of Gait, run by Ningbo Medical Center Lihuili Hospital 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 8 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 4 Apr 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?
Unified Parkinson's Disease Rating Scale (time frame: Within 24 hours before treatment, within 24 hours after treatment, 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?
On the ClinicalTrials.gov record for NCT06888778, 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 4 Apr 2025.