Repetitive Transcranial Magnetic StimulationNCT04804176
Study on the Mode and Mechanism of Ultra-low Frequency rTMS for Sleep Disorders in Patients With Parkinson's Disease
A study testing Ultra-low frequency repetitive transcranial magnetic stimulation in people with Repetitive Transcranial Magnetic Stimulation and Parkinson Disease, run by Qianfoshan Hospital at 1 site in China.
Trial summary
The study by giving a sleep disorder Parkinson's disease patients with different patterns of ultra-low frequency transcranial magnetic stimulation or sham stimulation, scale for assessment of the patients were observed, hematology and imaging changes before and after therapy, clear ultra-low frequency transcranial… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Repetitive Transcranial Magnetic Stimulation, Parkinson Disease, Sleep Disorder
- What is being tested?
- Ultra-low frequency repetitive transcranial magnetic stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 99 participants
- Where
- 1 siteChina
- Study dates
- 20 Dec 2019to 20 Apr 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- in line with international Movement disorders association (the Movement Disorder Society, MDS) in 2015 the diagnosis of Parkinson's disease diagnosis standard and China standard (2016)
- can cooperate to complete rating scale, the sleep monitoring, imaging and blood test
- have a sleep disorder
- aged 18 to 70 years old
- agree to participate in this experiment, and have signed the informed consent
Who cannot join
- superposition of diagnosed with Parkinson's syndrome
- secondary diagnosed Parkinson's syndrome
- is equipped with heart pacemakers and other metal implants
- cannot achieve scale assessment
- has significant malignant diseases
- has a history of seizures
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Shandong First Medical University
Jinan, Shandong
About this study
Official title: Study on the Mode and Mechanism of Ultra-low Frequency Repetitive Transcranial Magnetic Stimulation for Sleep Disorders in Patients With Parkinson's Disease
The study by giving a sleep disorder Parkinson's disease patients with different patterns of ultra-low frequency transcranial magnetic stimulation or sham stimulation, scale for assessment of the patients were observed, hematology and imaging changes before and after therapy, clear ultra-low frequency transcranial magnetic stimulation for sleep disorder Parkinson's disease treatment, to explore the mechanism of action, compare the difference between different modes.
Read the detailed description
Parkinson's disease is the second most common chronic neurodegenerative disease.At present, researchers focus not only on the motor symptoms of Parkinson's disease, but also on the non-motor symptoms of Parkinson's disease (including mood disorders, sleep disorders, cognitive decline, and autonomic nervous kinetic disorder, etc.).The principle of transcranial magnetic stimulation is based on the electromagnetic principle proposed by Faraday. When an electrifying coil is suspended over the scalp at a certain distance, the magnetic field generated by the coil current and the electric field generated by the magnetic field can reach the skull and directly or indirectly affect the synapses and neurons in the brain.The study by giving a sleep disorder Parkinson's disease patients with different patterns of ultra-low frequency transcranial magnetic stimulation or sham stimulation, scale for assessment of the patients were observed, hematology and imaging changes before and after therapy, clear ultra-low frequency transcranial magnetic stimulation for sleep disorder Parkinson's disease treatment, to explore the mechanism of action, compare the difference between different modes.
- Being tested
- Ultra-low frequency repetitive transcranial magnetic stimulation
- Keywords
- repetitive transcranial magnetic stimulation, Parkinson's disease, sleep disorder
- Medical subject headings
- Parkinson Disease, Sleep Wake Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultra-low frequency repetitive transcranial magnetic stimulationDevice
Two different modes of the instrument were used to treat patients in groups, to compare the efficacy.
| Study group | Role | What they receive |
|---|---|---|
| 5-HT mode of Ultra-low frequency repetitive transcranial magnetic stimulation | Active comparator | The study used 5-HT mode of Ultra-low frequency repetitive transcranial magnetic stimulation for 35 minutes once a day.Every 7 days is a cycle.The stimulus intensity was 400GS. Receives: Device: Ultra-low frequency repetitive transcranial magnetic stimulation |
| GABA mode of ultra-low frequency repetitive transcranial magnetic stimulation | Active comparator | The study used GABA mode of ultra-low frequency repetitive transcranial magnetic stimulation for 35 minutes once a day.Every 7 days is a cycle.The stimulus intensity was 400GS Receives: Device: Ultra-low frequency repetitive transcranial magnetic stimulation |
| the control group | Sham comparator | The instrument is not working, only in exhaust mode. Receives: Device: Ultra-low frequency repetitive transcranial magnetic stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
change from length of sleep at one week
Sleep duration was monitored by polysomnography.It's measured in minutes.
Measured: one week
change from ratio of stage 3 sleep in total sleep at one week
The proportion of phase 3 sleep in total sleep was monitored by polysomnography.It's in percentages.
Measured: one week
change from limb movement of sleep at one week
The number of body movements during sleep was recorded by polysomnography.It's in units of times per night.
Measured: one week
change from nocturnal arousal frequency at one week
The number of nocturnal awakenings was recorded by polysomnography.It's in units of times per night.
Measured: one week
change from Pittsburgh sleep quality index scale at one week
The scale was evaluated on the day before treatment and the day after treatment, which was based on scores.The total score of the scale ranges from 0 to 2L, and the higher the score, the worse the sleep quality.
Measured: 1 day before treatment、1 day after treatment、1 week after treatment、1 moth after treatment
Interleukin 6
It plays an important role in central nervous system diseases. In PD, the increase of IL-6 is the body's self-defense mechanism to protect neurons, and the change of IL-6 in peripheral blood can reflect the change of injury aggravation and recovery.It is also associated with psychiatric symptoms, and IL-6 is elevated in major depression.
Measured: 1 day before treatment and 1 day after treatment
change from the Epworth sleepiness scale at one week
The scale was evaluated on the day before treatment and the day after treatment, which was based on scores.The scale has an overall score range of 0 to 24, with higher scores indicating more severe sleepiness.
Measured: one week
change from Parkinson's disease sleep scale at one week
The scale was evaluated on the day before treatment and the day after treatment, which was based on scores.The total score of the scale ranges from 0 to 150. The higher the score, the better the sleep.
Measured: one week
change from movement disorders association - comprehensive rating scale of Parkinson's disease at one week
The scale was evaluated on the day before treatment and the day after treatment, which was based on scores.The total score of the scale ranged from 0 to 260, and the higher the score, the more severe the symptoms were.
Measured: one week
change from Parkinson's disease quality of life scale one week
The scale was evaluated on the day before treatment and the day after treatment, which was based on scores.The total score of the scale ranges from 0 to 156, and the higher the score, the worse the quality of life.
Measured: one week
change from Hamilton depression scale at one week
The scale was evaluated on the day before treatment and the day after treatment, which was based on scores.The total score of the scale ranged from 0 to 96, and the higher the score, the more severe the depression was.
Measured: one week
change from Hamilton anxiety scale at one week
The scale was evaluated on the day before treatment and the day after treatment, which was based on scores.The total score of the scale ranges from 0 to 56, and the higher the score, the more serious the anxiety.
Measured: one week
change from simple mental state scale at one week
The scale was evaluated on the day before treatment and the day after treatment, which was based on scores.The total score of the scale ranges from 0 to 30, and the lower the score, the more severe the cognitive impairment.
Measured: one week
change from Montreal cognitive assessment scale at one week
The scale was evaluated on the day before treatment and the day after treatment, which was based on scores.The total score of the scale ranges from 0 to 30, and the lower the score, the more severe the cognitive impairment.
Measured: one week
change from magnetic resonance imaging of the brain at one month
The ADC values of sleep-related brain tissues were measured by diffusion weighted magnetic resonance imaging of the brain.Compare the difference between the measured results on both sides of the same site and record the difference.
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2021
- Study start20 Dec 2019
- Primary completion20 Dec 2021 (estimated)
- Study completion20 Apr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Repetitive Transcranial Magnetic StimulationStudies of the same condition, open and under way.
- More trials run by Qianfoshan 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
- Model description
- The study was divided into three groups, which were control group, group A and group B.Groups A and B received different treatment modalities on the same device.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 99 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qianfoshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lili Cao, Qianfoshan Hospital
- Investigators
- Xiuhua Li, MD, Principal investigator, Qianfoshan Hospital，The First Affiliated Hospital of Shandong First Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04804176
- Sponsor's protocol ID
- ULFRTMS-S
- Status last verified
- Mar 2021
- First submitted
- 8 Mar 2021
- Last updated
- 24 Mar 2021
- 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 24 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Mode and Mechanism of Ultra-low Frequency Repetitive Transcranial Magnetic Stimulation for Sleep Disorders in Patients With Parkinson's Disease
- ClinicalTrials.gov ID
- NCT04804176
- Acronym / sponsor ID
- ULFRTMS-S
- Keywords
- repetitive transcranial magnetic stimulation, Parkinson's disease, sleep disorder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 99 participants (estimated)
- Lead sponsor
- Qianfoshan HospitalUniversity, hospital or other
- Study start
- 20 Dec 2019 (actual)
- Primary completion
- 20 Dec 2021 (estimated)
- Study completion
- 20 Apr 2022 (estimated)
- First posted
- 18 Mar 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.
The study by giving a sleep disorder Parkinson's disease patients with different patterns of ultra-low frequency transcranial magnetic stimulation or sham stimulation, scale for assessment of the patients were observed, hematology and imaging changes before and after therapy, clear ultra-low frequency transcranial magnetic stimulation for sleep disorder Parkinson's disease treatment, to explore the mechanism of action, compare the difference between different modes.
Detailed description
Parkinson's disease is the second most common chronic neurodegenerative disease.At present, researchers focus not only on the motor symptoms of Parkinson's disease, but also on the non-motor symptoms of Parkinson's disease (including mood disorders, sleep disorders, cognitive decline, and autonomic nervous kinetic disorder, etc.).The principle of transcranial magnetic stimulation is based on the electromagnetic principle proposed by Faraday. When an electrifying coil is suspended over the scalp at a certain distance, the magnetic field generated by the coil current and the electric field generated by the magnetic field can reach the skull and directly or indirectly affect the synapses and neurons in the brain.The study by giving a sleep disorder Parkinson's disease patients with different patterns of ultra-low frequency transcranial magnetic stimulation or sham stimulation, scale for assessment of the patients were observed, hematology and imaging changes before and after therapy, clear ultra-low frequency transcranial magnetic stimulation for sleep disorder Parkinson's disease treatment, to explore the mechanism of action, compare the difference between different modes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- The study was divided into three groups, which were control group, group A and group B.Groups A and B received different treatment modalities on the same device.
| Arm | Type | Receives |
|---|---|---|
| 5-HT mode of Ultra-low frequency repetitive transcranial magnetic stimulation | Active comparator | Device: Ultra-low frequency repetitive transcranial magnetic stimulationThe study used 5-HT mode of Ultra-low frequency repetitive transcranial magnetic stimulation for 35 minutes once a day.Every 7 days is a cycle.The stimulus intensity was 400GS. |
| GABA mode of ultra-low frequency repetitive transcranial magnetic stimulation | Active comparator | Device: Ultra-low frequency repetitive transcranial magnetic stimulationThe study used GABA mode of ultra-low frequency repetitive transcranial magnetic stimulation for 35 minutes once a day.Every 7 days is a cycle.The stimulus intensity was 400GS |
| the control group | Sham comparator | Device: Ultra-low frequency repetitive transcranial magnetic stimulationThe instrument is not working, only in exhaust mode. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- in line with international Movement disorders association (the Movement Disorder Society, MDS) in 2015 the diagnosis of Parkinson's disease diagnosis standard and China standard (2016)
- can cooperate to complete rating scale, the sleep monitoring, imaging and blood test
- have a sleep disorder
- aged 18 to 70 years old
- agree to participate in this experiment, and have signed the informed consent
Key exclusion criteria (6 listed)
- superposition of diagnosed with Parkinson's syndrome
- secondary diagnosed Parkinson's syndrome
- is equipped with heart pacemakers and other metal implants
- cannot achieve scale assessment
- has significant malignant diseases
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 |
|---|---|---|
| Ultra-low frequency repetitive transcranial magnetic stimulationTwo different modes of the instrument were used to treat patients in groups, to compare the efficacy. | Device | 5-HT mode of Ultra-low frequency repetitive transcranial magnetic stimulation, GABA mode of ultra-low frequency repetitive transcranial magnetic stimulation, the control group |
Primary outcome
change from length of sleep at one week
Time frame: one week
Sleep duration was monitored by polysomnography.It's measured in minutes.
change from ratio of stage 3 sleep in total sleep at one week
Time frame: one week
The proportion of phase 3 sleep in total sleep was monitored by polysomnography.It's in percentages.
change from limb movement of sleep at one week
Time frame: one week
The number of body movements during sleep was recorded by polysomnography.It's in units of times per night.
change from nocturnal arousal frequency at one week
Time frame: one week
The number of nocturnal awakenings was recorded by polysomnography.It's in units of times per night.
change from Pittsburgh sleep quality index scale at one week
Time frame: 1 day before treatment、1 day after treatment、1 week after treatment、1 moth after treatment
The scale was evaluated on the day before treatment and the day after treatment, which was based on scores.The total score of the scale ranges from 0 to 2L, and the higher the score, the worse the sleep quality.
Interleukin 6
Time frame: 1 day before treatment and 1 day after treatment
It plays an important role in central nervous system diseases. In PD, the increase of IL-6 is the body's self-defense mechanism to protect neurons, and the change of IL-6 in peripheral blood can reflect the change of injury aggravation and recovery.It is also associated with psychiatric symptoms, and IL-6 is elevated in major depression.
change from the Epworth sleepiness scale at one week
Time frame: one week
The scale was evaluated on the day before treatment and the day after treatment, which was based on scores.The scale has an overall score range of 0 to 24, with higher scores indicating more severe sleepiness.
change from Parkinson's disease sleep scale at one week
Time frame: one week
The scale was evaluated on the day before treatment and the day after treatment, which was based on scores.The total score of the scale ranges from 0 to 150. The higher the score, the better the sleep.
change from movement disorders association - comprehensive rating scale of Parkinson's disease at one week
Time frame: one week
The scale was evaluated on the day before treatment and the day after treatment, which was based on scores.The total score of the scale ranged from 0 to 260, and the higher the score, the more severe the symptoms were.
change from Parkinson's disease quality of life scale one week
Time frame: one week
The scale was evaluated on the day before treatment and the day after treatment, which was based on scores.The total score of the scale ranges from 0 to 156, and the higher the score, the worse the quality of life.
change from Hamilton depression scale at one week
Time frame: one week
The scale was evaluated on the day before treatment and the day after treatment, which was based on scores.The total score of the scale ranged from 0 to 96, and the higher the score, the more severe the depression was.
change from Hamilton anxiety scale at one week
Time frame: one week
The scale was evaluated on the day before treatment and the day after treatment, which was based on scores.The total score of the scale ranges from 0 to 56, and the higher the score, the more serious the anxiety.
change from simple mental state scale at one week
Time frame: one week
The scale was evaluated on the day before treatment and the day after treatment, which was based on scores.The total score of the scale ranges from 0 to 30, and the lower the score, the more severe the cognitive impairment.
change from Montreal cognitive assessment scale at one week
Time frame: one week
The scale was evaluated on the day before treatment and the day after treatment, which was based on scores.The total score of the scale ranges from 0 to 30, and the lower the score, the more severe the cognitive impairment.
change from magnetic resonance imaging of the brain at one month
Time frame: one month
The ADC values of sleep-related brain tissues were measured by diffusion weighted magnetic resonance imaging of the brain.Compare the difference between the measured results on both sides of the same site and record the difference.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2021.
- 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.
Xiuhua Li, MD principal investigator
Qianfoshan Hospital，The First Affiliated Hospital of Shandong First 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 Ultra-low frequency repetitive transcranial magnetic stimulation in people with Repetitive Transcranial Magnetic Stimulation and Parkinson Disease, run by Qianfoshan 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 6 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 24 Mar 2021. 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?
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?
change from length of sleep at one week (time frame: one week). The study lists 15 primary outcomes in all. 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 24 Mar 2021.