Parkinson DiseaseNCT05174299
The Effect of Multi-target Magnetic Stimulation on Freezing 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 multi-target magnetic stimulation treatment on Freezing of Gait (FOG) phenomenon 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
- 57 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2021to 30 Dec 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 40 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 1.Idiopathic Parkinson's disease (PD), as diagnosed by a neurologist.
- 2.Item 3 of the Freezing of Gait Questionnaire(FOG-Q) scored ≥1.
- 3.Age between 40 and 80 years old.
- 4.Mini-Mental State Examination score >24.
- 5.Ability to walk 30 meters independently.
- 6.Stable medication.
- 7.Patients experienced FOG in both medication "on" and "off" states.
Who cannot join
- 1.Other neurological or psychiatric disorders.
- 2.Severe personality disorder.History of epilepsy, seizures, or convulsions.
- 3.History of head injury or stroke.
- 4.Metal remains of the skull or inside the brain (outside the oral cavity).
- 5.Surgeries including metallic implants or known history of metal particles in the eye, pacemakers,hearing devices transplantation, or medical pumps.
- 6.Severe dyskinesia, termor, cognitive, visual or auditory impairment.
- 7.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 Multi-target Magnetic Stimulation on Freezing Gait in Parkinson's Disease
This study is a double-blinded randomized study examining the effectiveness of the multi-target magnetic stimulation treatment on Freezing of Gait (FOG) phenomenon in patients with Parkinson's disease. We hypothesize that treatment using magnetic stimulation on motor cortex combined with spinal cord 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 active magnetic stimulation with low frequency repetitive transcranial magnetic stimulation (rTMS) over the bilateral primary motor cortex of the lower leg followed by low frequency repetitive magnetic stimulation over the spinal cord, whereas patients in the Active Comparator group underwent ten sessions of single active magnetic stimulation with low 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 and spinal cord. Assessments of FOG, gait function, motor symptoms and excitability of primary motor cortex motor were performed three times: at baseline, one day post intervention, one month post intervention.
- Conditions
- Parkinson Disease
- Being tested
- magnetic stimulation
- Keywords
- freezing of gait, Therapeutics, rTMS, spinal cord 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.
magnetic stimulationDevice
For Experimental Arm, active magnetic stimulation on motor cortex followed by active magnetic stimulation on spinal cord, patients underwent ten sessions of double active magnetic stimulation with low frequency repetitive transcranial magnetic stimulation (rTMS) over the bilateral primary motor cortex of the lower leg followed by low frequency repetitive magnetic stimulation over the spinal cord. For Active Comparator Arm, active magnetic stimulation on motor cortex followed by sham magnetic stimulation on spinal cord. For Sham Comparator Arm, sham magnetic stimulation on motor cortex followed by sham magnetic stimulation on spinal cord.
| Study group | Role | What they receive |
|---|---|---|
| double active magnetic stimulation | Experimental | the multi-target magnetic stimulation on motor cortex combined with spinal cord Receives: Device: magnetic stimulation |
| single active magnetic stimulation | Active comparator | the active magnetic stimulation on motor cortex and sham stimulation on spinal cord Receives: Device: magnetic stimulation |
| double sham magnetic stimulation | Sham comparator | the sham magnetic stimulation on motor cortex and sham stimulation on spinal cord 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 (FOG-Q)
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.
Measured: Assessed at baseline, one day post intervention, one month post intervention
Secondary outcomes (10)
The motor part of the Unified Parkinson's Disease Rating Scale
The measure mainly reflects the overall severity of Parkinson's disease motor symptoms. The minimum and maximum values of the motor part of the Unified Parkinson's Disease Rating Scale are 0 and 108. A higher score means a worse outcome.
Measured: Assessed at baseline, one day post intervention, one month post intervention
Gait speed
Gait speed (m/s) was evaluated at baseline, one day post intervention, one month post intervention using a portable Inertial Measurement Unit system during a 5-m timed Up-and-Go (TUG) test.
Measured: Assessed at baseline, one day post intervention, one month post intervention
Stride length
Stride length (cm) was evaluated at baseline, one day post intervention, one month post intervention using a portable Inertial Measurement Unit system during a 5-m timed Up-and-Go (TUG) test.
Measured: Assessed at baseline, one day post intervention, one month post intervention
Stride time variability
Stride time variability (%) was evaluated at baseline, one day post intervention, one month post intervention using a portable Inertial Measurement Unit system during a 5-m timed Up-and-Go (TUG) test.
Stride time variability was expressed as coefficient of variation [CV].
Measured: Assessed at baseline, one day post intervention, one month post intervention
Double support
Double support (%) was evaluated at baseline, one day post intervention, one month post intervention using a portable Inertial Measurement Unit system during a 5-m timed Up-and-Go (TUG) test.
Measured: Assessed at baseline, one day post intervention, one 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.
Measured: Assessed at baseline, one day post intervention.
MEP amplitude at 120% RMT intensity (AMP)
Five single stimuli were delivered to the optimal stimulation point at an intensity of 120% of RMT, and the mean peak-to-peak amplitude of the MEPs was calculated, which is the AMP (mV).
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.
Individuals were asked to actively contract abductor pollicis brevis (APB) with 20% of the maximum force, while a single pulse with 150% of RMT was applied to the opposite primary motor cortex. We recorded the time from pulse outputting to the recovery of inhibited active contraction as CSP. The above protocol was repeated ten times, and the average value of CSP was calculated.
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 a 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.
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 a 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.
Measured: Assessed at baseline, one day post intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2021
- Study start1 Oct 2021
- Primary completion30 Nov 2022 (estimated)
- Study completion30 Dec 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 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
- 57 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- 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
- NCT05174299
- Sponsor's protocol ID
- 2021-SR-209
- Status last verified
- Dec 2022
- First submitted
- 8 Nov 2021
- Last updated
- 6 Dec 2022
- Results posted
- 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 6 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Multi-target Magnetic Stimulation on Freezing Gait in Parkinson's Disease
- ClinicalTrials.gov ID
- NCT05174299
- Acronym / sponsor ID
- 2021-SR-209
- Conditions
- Parkinson Disease
- Keywords
- freezing of gait, Therapeutics, rTMS, spinal cord stimulation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 57 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 30 Nov 2022 (estimated)
- Study completion
- 30 Dec 2022 (estimated)
- First posted
- 30 Dec 2021 (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 multi-target magnetic stimulation treatment on Freezing of Gait (FOG) phenomenon in patients with Parkinson's disease. We hypothesize that treatment using magnetic stimulation on motor cortex combined with spinal cord will improve FOG and gait symptoms in patients with Parkinson's disease.
Detailed description
Patients in the Experimental group underwent ten sessions of double active magnetic stimulation with low frequency repetitive transcranial magnetic stimulation (rTMS) over the bilateral primary motor cortex of the lower leg followed by low frequency repetitive magnetic stimulation over the spinal cord, whereas patients in the Active Comparator group underwent ten sessions of single active magnetic stimulation with low 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 and spinal cord. Assessments of FOG, gait function, motor symptoms and excitability of primary motor cortex motor were performed three times: at baseline, one day post intervention, one 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 active magnetic stimulation | Experimental | Device: magnetic stimulationthe multi-target magnetic stimulation on motor cortex combined with spinal cord |
| single active magnetic stimulation | Active comparator | Device: magnetic stimulationthe active magnetic stimulation on motor cortex and sham stimulation on spinal cord |
| double sham magnetic stimulation | Sham comparator | Device: magnetic stimulationthe sham magnetic stimulation on motor cortex and sham stimulation on spinal cord |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 1.Idiopathic Parkinson's disease (PD), as diagnosed by a neurologist.
- 2.Item 3 of the Freezing of Gait Questionnaire(FOG-Q) scored ≥1.
- 3.Age between 40 and 80 years old.
- 4.Mini-Mental State Examination score >24.
- 5.Ability to walk 30 meters independently.
Key exclusion criteria (7 listed)
- 1.Other neurological or psychiatric disorders.
- 2.Severe personality disorder.History of epilepsy, seizures, or convulsions.
- 3.History of head injury or stroke.
- 4.Metal remains of the skull or inside the brain (outside the oral cavity).
- 5.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 stimulationFor Experimental Arm, active magnetic stimulation on motor cortex followed by active magnetic stimulation on spinal cord, patients underwent ten sessions of double active magnetic stimulation with low frequency repetitive transcranial magnetic stimulation (rTMS) over the bilateral primary motor cortex of the lower leg followed by low frequency repetitive magnetic stimulation over the spinal cord. For Active Comparator Arm, active magnetic stimulation on motor cortex followed by sham magnetic stimulation on spinal cord. For Sham Comparator Arm, sham magnetic stimulation on motor cortex followed by sham magnetic stimulation on spinal cord. | Device | double active magnetic stimulation, double sham magnetic stimulation, single active magnetic stimulation |
Primary outcome
Changes of Freezing of Gait Questionnaire (FOG-Q)
Time frame: Assessed at baseline, one day post intervention, one month 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.
10 secondary outcomes
The motor part of the Unified Parkinson's Disease Rating Scale
Time frame: Assessed at baseline, one day post intervention, one month post intervention
Gait speed
Time frame: Assessed at baseline, one day post intervention, one month post intervention
Stride length
Time frame: Assessed at baseline, one day post intervention, one month post intervention
Stride time variability
Time frame: Assessed at baseline, one day post intervention, one month post intervention
Double support
Time frame: Assessed at baseline, one day post intervention, one month post intervention
Resting motor threshold (RMT)
Time frame: Assessed at baseline, one day post intervention.
MEP amplitude at 120% RMT intensity (AMP)
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2022.
- 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 6 Dec 2022. 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 (FOG-Q) (time frame: Assessed at baseline, one day post intervention, one month 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 6 Dec 2022.