Parkinson DiseaseNCT04431570
Repetitive Transcranial Magnetic Stimulation for the Treatment of Freezing of Gait in Parkinson's Disease
A study testing rTMS in people with Parkinson Disease and Gait Disorders, Neurologic, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
Freezing of gait (FOG) is a common and devastating symptom in advanced stage Parkinson's disease (PD), which contributes to falls and disability. Unfortunately, there is no effective pharmacological treatment for FOG. Read more about this study
- Who is it for?
- Ages 50 to 70 years
- Conditions the study is for
- Parkinson Disease, Gait Disorders, Neurologic
- What is being tested?
- rTMS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 1 siteChina
- Study dates
- 15 Jun 2020to 14 Jun 2022
- 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 50 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects fulfilled the diagnosis of idiopathic Parkinson's disease according to MDS-PD criteria
- Hoehn \& Yahr (H-Y) stage was 2 or 3
- All subjects had freezing of gait which was identified by FOGQ
Who cannot join
- cognitive impairment (MMSE score<22) or major depression (HAMD-24 score>25)
- severe visual and/or haring impairment
- significant medical or psychiatric illnesses
- history of deep brain stimulation (DBS) surgery or pacemaker implantation. MRI cannot be performed in those patients
- current treatment with medication cannot be maintained during the study
Trial locations and contacts
1 site in 1 country.
China1 site
Peking Union Medical College Hospital
Beijing, 100730
Taisheng Li, MD. PhD., 86 10 65295086, Litsh@263.net
Taisheng Li, MD, PhD
About this study
Official title: Repetitive Transcranial Magnetic Stimulation for the Treatment of Freezing of Gait in Parkinson's Disease: A Randomized Controlled Trial
Freezing of gait (FOG) is a common and devastating symptom in advanced stage Parkinson's disease (PD), which contributes to falls and disability. Unfortunately, there is no effective pharmacological treatment for FOG. It is suggested that the cortex-basal ganglia circuit, especially the frontal lobe, plays an important role in the pathogenesis of FOG. Repetitive transcranial magnetic stimulation (rTMS) effects over the cortex and affects the subcortical neural circuits. Previous studies have demonstrated that rTMS can improve FOG for PD patients. In the present randomized controlled trial (RCT) study, the invastigators aim to investigate the efficiency of rTMS over different motor regions of frontal lobe. The efficacy of treatment is evaluated by the score of FOG questionnaire and FOG provoking test, and the changing of neural network shown by functional magnetic resonance imaging (FMRI). Then the effects of rTMS over different brain regions will be compared for choosing a better target. The study will provide the evidence for non-invasive neuro-modulation of Parkinson's disease with freezing of gait (PD-FOG).
- Conditions
- Parkinson Disease, Gait Disorders, Neurologic
- Being tested
- rTMS, sham stimulation
- Keywords
- freezing of gait, FMRI, rTMS
- Medical subject headings
- Parkinson Disease, Gait Disorders, Neurologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rTMSDevice
The device is made in London, United Kingdom
sham stimulationDevice
the device of sham stimulation was MagStim MC-P-B70 placebo butterfly coil
| Study group | Role | What they receive |
|---|---|---|
| rTMS over M1 region | Experimental | The stimulus intensity was set to 100% of the resting motor threshold. Ten sessions of rTMS were delivered over 2 weeks, one session per day for 5 consecutive days per week. Each session consisted of 10 trains of 100 pulses at 10Hz with an inter-train interval of 40 seconds. In this group, the target of rTMS is M1 region. Receives: Device: rTMS |
| rTMS over supplementary motor area (SMA) | Experimental | The stimulus intensity was set to 100% of the resting motor threshold. Ten sessions of rTMS were delivered over 2 weeks, one session per day for 5 consecutive days per week. Each session consisted of 10 trains of 100 pulses at 10Hz with an inter-train interval of 40 seconds. In this group, the target of rTMS is SMA region. Receives: Device: rTMS |
| sham stimulation | Sham comparator | Not described Receives: Device: sham stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
the change of freezing of gait questionnaire (FOGQ)
a self-assessment scale for evaluating FOG severity，the minimum value is 0, the maximum value is 24, and higher scores mean a worse outcome.
Measured: through study completion, an average of 2 weeks
Secondary outcomes (6)
the change of freezing of gait score (FOG score)
assess the severity of FOG, the minimum value is 0, the maximum value is 36, and higher scores mean a worse outcome.
Measured: through study completion, an average of 2 weeks
the change of score of Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) part III
assess the motor ability, the minimum value is 0, the maximum value is 132, and higher scores mean a worse outcome.
Measured: through study completion, an average of 2 weeks
the change of Hamilton Depression (HAMD) Scale
assess the severity of depression, the minimum value is 0, the maximum value is 76, and higher scores mean a worse outcome.
Measured: through study completion, an average of 2 weeks
the change of Mini-mental State Examination (MMSE) scale
assess the severity of mental state, the minimum value is 0, the maximum value is 30, and higher scores mean a worse outcome.
Measured: through study completion, an average of 2 weeks
the change of Parkinson's Disease Questionnaire (PDQ-39)
assess the quality of life, the minimum value is 0, the maximum value is 156, and higher scores mean a worse outcome.
Measured: through study completion, an average of 2 weeks
functional image of the brain (FMRI)
graph theoretical analysis of the brain network
Measured: through study completion, an average of 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2020
- Study start15 Jun 2020 (estimated)
- Primary completion14 Apr 2022 (estimated)
- Study completion14 Jun 2022 (estimated)
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 Peking Union Medical College HospitalThe 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04431570
- Sponsor's protocol ID
- rTMSPDFOG-PUMCH
- Status last verified
- Jun 2020
- First submitted
- 27 Apr 2020
- Last updated
- 16 Jun 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Repetitive Transcranial Magnetic Stimulation for the Treatment of Freezing of Gait in Parkinson's Disease: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04431570
- Acronym / sponsor ID
- rTMSPDFOG-PUMCH
- Conditions
- Parkinson Disease, Gait Disorders, Neurologic
- Keywords
- freezing of gait, FMRI, rTMS
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 15 Jun 2020 (estimated)
- Primary completion
- 14 Apr 2022 (estimated)
- Study completion
- 14 Jun 2022 (estimated)
- First posted
- 16 Jun 2020 (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.
Freezing of gait (FOG) is a common and devastating symptom in advanced stage Parkinson's disease (PD), which contributes to falls and disability. Unfortunately, there is no effective pharmacological treatment for FOG. It is suggested that the cortex-basal ganglia circuit, especially the frontal lobe, plays an important role in the pathogenesis of FOG. Repetitive transcranial magnetic stimulation (rTMS) effects over the cortex and affects the subcortical neural circuits. Previous studies have demonstrated that rTMS can improve FOG for PD patients. In the present randomized controlled trial (RCT) study, the invastigators aim to investigate the efficiency of rTMS over different motor regions of frontal lobe. The efficacy of treatment is evaluated by the score of FOG questionnaire and FOG provoking test, and the changing of neural network shown by functional magnetic resonance imaging (FMRI). Then the effects of rTMS over different brain regions will be compared for choosing a better target. The study will provide the evidence for non-invasive neuro-modulation of Parkinson's disease with freezing of gait (PD-FOG).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| rTMS over M1 region | Experimental | Device: rTMSThe stimulus intensity was set to 100% of the resting motor threshold. Ten sessions of rTMS were delivered over 2 weeks, one session per day for 5 consecutive days per week. Each session consisted of 10 trains of 100 pulses at 10Hz with an inter-train interval of 40 seconds. In this group, the target of rTMS is M1 region. |
| rTMS over supplementary motor area (SMA) | Experimental | Device: rTMSThe stimulus intensity was set to 100% of the resting motor threshold. Ten sessions of rTMS were delivered over 2 weeks, one session per day for 5 consecutive days per week. Each session consisted of 10 trains of 100 pulses at 10Hz with an inter-train interval of 40 seconds. In this group, the target of rTMS is SMA region. |
| sham stimulation | Sham comparator | Device: sham stimulation |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subjects fulfilled the diagnosis of idiopathic Parkinson's disease according to MDS-PD criteria
- Hoehn \& Yahr (H-Y) stage was 2 or 3
- All subjects had freezing of gait which was identified by FOGQ
Key exclusion criteria (5 listed)
- cognitive impairment (MMSE score<22) or major depression (HAMD-24 score>25)
- severe visual and/or haring impairment
- significant medical or psychiatric illnesses
- history of deep brain stimulation (DBS) surgery or pacemaker implantation. MRI cannot be performed in those patients
- current treatment with medication cannot be maintained during the study
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 |
|---|---|---|
| rTMSThe device is made in London, United Kingdom | Device | rTMS over M1 region, rTMS over supplementary motor area (SMA) |
| sham stimulationthe device of sham stimulation was MagStim MC-P-B70 placebo butterfly coil | Device | sham stimulation |
Primary outcome
the change of freezing of gait questionnaire (FOGQ)
Time frame: through study completion, an average of 2 weeks
a self-assessment scale for evaluating FOG severity，the minimum value is 0, the maximum value is 24, and higher scores mean a worse outcome.
6 secondary outcomes
the change of freezing of gait score (FOG score)
Time frame: through study completion, an average of 2 weeks
the change of score of Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) part III
Time frame: through study completion, an average of 2 weeks
the change of Hamilton Depression (HAMD) Scale
Time frame: through study completion, an average of 2 weeks
the change of Mini-mental State Examination (MMSE) scale
Time frame: through study completion, an average of 2 weeks
the change of Parkinson's Disease Questionnaire (PDQ-39)
Time frame: through study completion, an average of 2 weeks
functional image of the brain (FMRI)
Time frame: through study completion, an average of 10 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2020.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing rTMS in people with Parkinson Disease and Gait Disorders, Neurologic, run by Peking Union Medical College 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 3 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 16 Jun 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Han Wang, doctor (+8618600044179, 18600044179@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the change of freezing of gait questionnaire (FOGQ) (time frame: through study completion, an average of 2 weeks). 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 16 Jun 2020.