Parkinson DiseaseNCT05925296
The Effect of Dual-site Repetitive Transcranial Magnetic Stimulation on Freezing of Gait in PD
A study testing 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 effectiveness of the dual-site 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?
- magnetic stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 53 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2022to 1 Sep 2023
- 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
- Idiopathic Parkinson's disease (PD), as diagnosed by a neurologist.
- Item 3 of the Freezing of Gait Questionnaire(FOG-Q) scored ≥1.
- Age between 40 and 80 years old.
- Mini-Mental State Examination score >24.
- Ability to walk 30 meters independently.
- Stable medication.
- Patients experienced FOG during an interview.
Who cannot join
- Other neurological or psychiatric disorders.
- Severe personality disorder. History of epilepsy, seizures, or convulsions.
- History of head injury or stroke.
- Metal remains of the skull or inside the brain (outside the oral cavity).
- Surgeries including metallic implants or known history of metal particles in the eye, pacemakers,hearing devices transplantation, or medical pumps.
- Severe dyskinesia, tremor, cognitive, visual or auditory impairment.
- Patients who could not complete the follow-up.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
the First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, 210029
Kezhong Zhang, 13770840575, kezhong_zhang1969@126.com
About this study
Official title: The Effect of Dual-site Repetitive Transcranial Magnetic Stimulation on Freezing of Gait in Patients With Parkinson Disease
This study is a double-blinded randomized study examining the effectiveness of the dual-site 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 Experimental 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 Active Comparator 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 Comparator group underwent 10 sessions of double sham rTMS on motor cortex. Assessments of FOG, gait function, 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, six month post intervention.
- Conditions
- Parkinson Disease
- Being tested
- magnetic stimulation
- Keywords
- freezing of gait, rTMS
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
magnetic stimulationDevice
Patients in the Experimental 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 Active Comparator 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 Comparator group underwent 10 sessions of double sham rTMS on motor cortex.
| 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: magnetic stimulation |
| single-site high frequency rTMS over the bilateral primary motor cortex 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: magnetic stimulation |
| sham magnetic stimulation on motor cortex | Sham comparator | Patients in the Sham Comparator group underwent 10 sessions of double sham rTMS on M1. Receives: Device: magnetic stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of Freezing of Gait Questionnaire
The Freezing of Gait questionnaire will be used to quantify the frequency and severity of this symptom. The score will be compared to the baseline. The minimum and maximum values of the FOG-Q are 0 and 24. A higher FOG-Q score means a worse outcome. The differences in FOG-Q 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, six months post intervention
Secondary outcomes (14)
Changes of MDS-UPDRS
The measure mainly reflects the overall severity of Parkinson's disease motor symptoms and non-motor symptoms. A higher score means a worse outcome. The score will be compared to the baseline. The differences in MDS-UPDRS 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, six months post intervention
Gait speed
Gait speed (m/s) was evaluated at baseline, one day post intervention, one month post intervention, six 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, six month post intervention
Stride length
Stride length (cm) was evaluated at baseline, one day post intervention, one month post intervention, six 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, six month post intervention
Stride time variability
Stride time variability (%) was evaluated at baseline, one day post intervention, one month post intervention, six month post intervention using a portable Inertial Measurement Unit system during a 5-m timed Up-and-Go (TUG) test. The differences in stride time variability 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, six month post intervention
Double support
Double support (%) was evaluated at baseline, one day post intervention, one month post intervention, six month post intervention using a portable Inertial Measurement Unit system during a 5-m timed Up-and-Go (TUG) test. The differences in double support 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, six month post intervention
Resting motor threshold (RMT)
RMT (% TMS output intensity) is defined as the lowest intensity required to elicit MEPs of > 50 μV in at least 5 of 10 consecutive trials while the target muscle is relaxed. RMT was determined to be the nearest 1% of the maximum stimulator output. The differences in RMT before and after treatment can be used to evaluate the effect of TMS treatment.
Measured: Assessed at baseline, one day post intervention
Cortical silent period (CSP)
The CSP (ms) is measured through electromyographic signal recording (EMG) on a target muscle and refers to the period of EMG silence following the elicitation of a motor-evoked potential (MEP) through a single TMS pulse delivered over the contralateral primary motor cortex. The differences in CSP before and after treatment can be used to evaluate the effect of TMS treatment.
Measured: Assessed at baseline, one day post intervention
Short-interval intracortical inhibition (SICI)
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. Ten trials were acquired for each interstimulus interval. SICI was expressed as the percentage ratio between the test and conditioning MEP. The differences in SICI before and after treatment can be used to evaluate the effect of TMS treatment.
Measured: Assessed at baseline, one day post intervention
Intracortical facilitation (ICF)
ICF was assessed with a subthreshold conditioning stimulus (80% RMT) and a supra-threshold test stimulus (1 mV MEP) with 10ms, 12, 15 ms interstimulus interval between conditioning and test stimuli. Ten trials were acquired for each interstimulus interval. ICF was expressed as the percentage ratio between the test and conditioning MEP. The differences in ICF before and after treatment can be used to evaluate the effect of TMS treatment.
Measured: Assessed at baseline, one day post intervention
Short-interval intracortical facilitation (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. Ten trials for each and ten single-pulse trials were given in randomized order. SICF was expressed as the percentage ratio between the S1 and S2 MEP. The differences in SICF before and after treatment can be used to evaluate the effect of TMS treatment.
Measured: Assessed at baseline, one day post intervention
Plasma indicators
5ml of the patient's elbow vein blood was collected and centrifuged after standing and stratified. The blood plasma was collected and frozen at - 80°C for testing. Detection of changes in plasma BDNF levels. The differences in BDNF 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, six month post intervention
Changes in cerebral blood flow in the brain cortex
The cerebral blood flow will be assessed by arterial spin labeling scanning. The differences in blood flow before and after treatment can be used to evaluate the effect of TMS treatment.
Measured: Assessed at baseline, one day post intervention, six month post intervention
Brian structure compared among groups
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, six month post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2023
- Study start1 Aug 2022
- Primary completion1 Sep 2023 (estimated)
- Study completion1 Sep 2023 (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 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
- 53 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- National Natural Science Foundation of China
- Responsible party
- Principal investigator, Kezhong Zhang, The First Affiliated Hospital with Nanjing Medical University
- Investigators
- Kezhong Zhang, Principal investigator, The First Affiliated Hospital with Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05925296
- Sponsor's protocol ID
- 2022-SRFA-020
- Status last verified
- Jun 2023
- First submitted
- 12 Jun 2023
- Last updated
- 3 Jul 2023
- 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 3 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Dual-site Repetitive Transcranial Magnetic Stimulation on Freezing of Gait in Patients With Parkinson Disease
- ClinicalTrials.gov ID
- NCT05925296
- Acronym / sponsor ID
- 2022-SRFA-020
- Conditions
- Parkinson Disease
- Keywords
- freezing of gait, rTMS
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 53 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Collaborators
- National Natural Science Foundation of China
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 1 Sep 2023 (estimated)
- Study completion
- 1 Sep 2023 (estimated)
- First posted
- 29 Jun 2023 (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 effectiveness of the dual-site 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 Experimental 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 Active Comparator 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 Comparator group underwent 10 sessions of double sham rTMS on motor cortex. Assessments of FOG, gait function, 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, six 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: 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 primary motor cortex of the lower leg | Active comparator | Device: 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 motor cortex | Sham comparator | Device: magnetic stimulationPatients in the Sham Comparator group underwent 10 sessions of double sham rTMS on M1. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Idiopathic Parkinson's disease (PD), as diagnosed by a neurologist.
- Item 3 of the Freezing of Gait Questionnaire(FOG-Q) scored ≥1.
- Age between 40 and 80 years old.
- Mini-Mental State Examination score >24.
- Ability to walk 30 meters independently.
Key exclusion criteria (7 listed)
- Other neurological or psychiatric disorders.
- Severe personality disorder. History of epilepsy, seizures, or convulsions.
- History of head injury or stroke.
- Metal remains of the skull or inside the brain (outside the oral cavity).
- Surgeries including metallic implants or known history of metal particles in the eye, pacemakers,hearing devices transplantation, or medical pumps.
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 |
|---|---|---|
| magnetic stimulationPatients in the Experimental 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 Active Comparator 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 Comparator group underwent 10 sessions of double sham rTMS on motor cortex. | Device | double-site high frequency rTMS over the bilateral M1 of the lower leg and SMA, sham magnetic stimulation on motor cortex, single-site high frequency rTMS over the bilateral primary motor cortex of the lower leg |
Primary outcome
Changes of Freezing of Gait Questionnaire
Time frame: Assessed at baseline, one day post intervention, one month post intervention, six months post intervention
The Freezing of Gait questionnaire will be used to quantify the frequency and severity of this symptom. The score will be compared to the baseline. The minimum and maximum values of the FOG-Q are 0 and 24. A higher FOG-Q score means a worse outcome. The differences in FOG-Q scores before and after treatment can be used to evaluate the effect of TMS treatment.
14 secondary outcomes
Changes of MDS-UPDRS
Time frame: Assessed at baseline, one day post intervention, one month post intervention, six months post intervention
Gait speed
Time frame: Assessed at baseline, one day post intervention, one month post intervention, six month post intervention
Stride length
Time frame: Assessed at baseline, one day post intervention, one month post intervention, six month post intervention
Stride time variability
Time frame: Assessed at baseline, one day post intervention, one month post intervention, six month post intervention
Double support
Time frame: Assessed at baseline, one day post intervention, one month post intervention, six month post intervention
Resting motor threshold (RMT)
Time frame: Assessed at baseline, one day post intervention
Cortical silent period (CSP)
Time frame: Assessed at baseline, one day post intervention
Short-interval intracortical inhibition (SICI)
Time frame: Assessed at baseline, one day post intervention
Intracortical facilitation (ICF)
Time frame: Assessed at baseline, one day post intervention
Short-interval intracortical facilitation (SICF)
Time frame: Assessed at baseline, one day post intervention
Plasma indicators
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, six month post intervention
Changes in cerebral blood flow in the brain cortex
Time frame: Assessed at baseline, one day post intervention, six month post intervention
Brian structure compared among groups
Time frame: Assessed at baseline, one day post intervention, six month post intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2023.
- 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 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 7 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: status not confirmed, as of the sponsor's last update on 3 Jul 2023. 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 Kezhong Zhang (13770840575, kezhong_zhang1969@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes of Freezing of Gait Questionnaire (time frame: Assessed at baseline, one day post intervention, one month post intervention, six months 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 3 Jul 2023.