NeuromodulationNCT06193278
Individual Neuromodulation for PDS
A study testing Neuromodulation in people with Neuromodulation and Parkinsonian Syndromes, run by Ruijin Hospital at 1 site in China.
Trial summary
Parkinsonian Syndromes (PDS) with predominant motor dysfunction include progressive supranuclear palsy (PSP), multiple system atrophy (MSA) and corticobasal degeneration (CBD). Current treatment options for PDS are extremely limited due to the less understanding of disease pathophysiology and lack of therapeutic… Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Neuromodulation, Parkinsonian Syndromes, Transcranial Magnetic Stimulation
- What is being tested?
- Neuromodulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2023to 30 Jun 2025
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Compliance with the MDS revised clinical diagnostic criteria for Parkinsonian syndrome (2015 edition)
- aged >40 years and <80 years, regardless of gender.
- Patients were relatively stable during the study period and remained stable on medication
- Good compliance, written informed consent, and consent for NIBS long-term intervention treatment
Who cannot join
- Patients with severe neuropsychiatric disorders or a previous history of severe neurologic conditions (e.g., epilepsy, cerebrovascular accident, etc.) or traumatic brain injury or brain surgery
- inability to complete the questionnaire independently
- Previous treatment with DBS or SCS; TMS or tDCS within 6 months
- Severe physical illness and any physical condition that can precipitate epilepsy or intracranial hypertension, including cardiovascular and respiratory diseases
- Installation of intracranial stents, pacemakers, coronary stents, cochlear implants, and other human implantable materials
- is currently taking other investigational drugs or is participating in other clinical trials
- Any other condition that the investigator believes makes him or her unsuitable for participation in this study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Neurology and Institute of Neurology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200025
Jun Liu, MD,PhD, 64370045 ext. +86-021, jly0520@hotmail.com
About this study
Official title: Personalized Neuromodulation Treatment for Parkinson's Syndrome
Parkinsonian Syndromes (PDS) with predominant motor dysfunction include progressive supranuclear palsy (PSP), multiple system atrophy (MSA) and corticobasal degeneration (CBD). Current treatment options for PDS are extremely limited due to the less understanding of disease pathophysiology and lack of therapeutic targets. Combining the results of previous studies and our group's previous research, sixty qualified PDS patients would be enrolled to conduct a prospective single-center randomized sham controlled clinical trial to verify the new therapeutic options that can improve symptoms and effectively slow the progression of the disease.
- Conditions
- Neuromodulation, Parkinsonian Syndromes, Transcranial Magnetic Stimulation, Transcranial Direct Current Stimulation
- Being tested
- Neuromodulation
- Medical subject headings
- Parkinsonian Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeuromodulationDevice
Noninvasive brain stimulation (NIBS) includes a variety of noninvasive neuromodulation techniques such as transcranial magnetic stimulation (TMS), transcranial direct current stimulation (TDCS), and so on. Theta burst stimulation(TBS) is a new form of excitatory or inhibitory rTMS treatment that is less time-consuming and more effective than traditional rTMS in a single treatment session.
| Study group | Role | What they receive |
|---|---|---|
| muti-site stimulation group1 | Active comparator | The intervention period: 2 weeks muti-site: individual target (iTBS OR cTBS) / M1 (iTBS) Receives: Device: Neuromodulation |
| single-site stimulation group2 | Active comparator | The intervention period: 2 weeks muti-site: individual target (sham) / M1 (iTBS) Receives: Device: Neuromodulation |
| sham stimulation group3 | Sham comparator | The intervention period: 2 weeks muti-site: individual target (sham) / M1 (sham) Receives: Device: Neuromodulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Group differences of part 3 of Unified Parkinson Disease Rating Scale (UPDRS) changes
Compare the changes in UPDRS scores from baseline to post- treatment in the three intervention groups (UPDRS part3: range 0~72, higher score is related to a worse outcome).
Measured: 6 weeks
Secondary outcomes (12)
Group differences of Progressive Supranuclear Palsy Rating Scale (PSPRS)
Compare the changes in PSPRS scores from baseline to post- treatment in the three intervention groups (psp patients specific).
Measured: 6 weeks
Group differences of Unified Multiple System Atrophy Rating Scale (UMSARS)
Compare the changes in UMSARS scores from baseline to post- treatment in the three intervention groups (MSA patients specific).
Measured: 6 weeks
Group differences of Cortical Basal ganglia Functional Scale (CBFS)
Compare the changes in CBFS scores from baseline to post- treatment in the three intervention groups (cbd patients specific).
Measured: 6 weeks
Group differences of Berg Balance Scale (BBS) changes
Compare the changes in BBS scores from baseline to post-treatment in the three intervention groups (BBS: range 0~56, higher score is related to a better outcome).
Measured: 6 weeks
Group differences of Hamilton depression scale-17 (HAMD-17) changes
Compare the changes in HAMD-17 scores from baseline to post-treatment in the three intervention groups (HAMD-17: range 0~38, higher score is related to a worse outcome).
Measured: 6 weeks
Group differences of Hamilton Anxiety Scale (HAMA) changes
Compare the changes in HAMA scores from baseline to post-treatment in the three intervention groups (HAMA: range 0~64, higher score is related to a worse outcome).
Measured: 6 weeks
Group differences of Mini-mental State Examination (MMSE) changes
Compare the changes in MMSE scores from baseline to post-treatment in the three intervention groups (MMSE: range 0~30, higher score is related to a better outcome).
Measured: 6 weeks
Group differences of Montreal Cognitive Assessment (MoCA) changes
Compare the changes in MoCA scores from baseline to post-treatment in the three intervention groups (MoCA: range 0~30, higher score is related to a better outcome).
Measured: 6 weeks
Group differences of 39-item Parkinson's Disease Questionnaire (PDQ-39) changes
Compare the changes in PDQ-39 scores from baseline to post-treatment in the three intervention groups (PDQ-39: range 0~156, higher score is related to a worse outcome).
Measured: 6 weeks
Group differences of Wexner scores changes
Compare the changes in Wexner scores from baseline to post-treatment in the three intervention groups (Wexner: range 0~30, higher score is related to a worse outcome).
Measured: 6 weeks
Group differences of Standardized Swallowing Assessment (SSA) changes
Compare the changes in SSA from baseline to post-treatment in the three intervention groups
Measured: 6 weeks
Group differences of adverse event
Compare the changes in adverse event in the three intervention groups
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2024
- Study start1 Sep 2023
- Primary completion31 May 2025 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeuromodulationStudies of the same condition, open and under way.
- More trials run by Ruijin 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06193278
- Sponsor's protocol ID
- PDS
- Status last verified
- Aug 2023
- First submitted
- 21 Dec 2023
- Last updated
- 10 Jan 2024
- 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 10 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personalized Neuromodulation Treatment for Parkinson's Syndrome
- ClinicalTrials.gov ID
- NCT06193278
- Acronym / sponsor ID
- PDS
- Conditions
- Neuromodulation, Parkinsonian Syndromes, Transcranial Magnetic Stimulation, Transcranial Direct Current Stimulation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 31 May 2025 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 5 Jan 2024 (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.
Parkinsonian Syndromes (PDS) with predominant motor dysfunction include progressive supranuclear palsy (PSP), multiple system atrophy (MSA) and corticobasal degeneration (CBD). Current treatment options for PDS are extremely limited due to the less understanding of disease pathophysiology and lack of therapeutic targets. Combining the results of previous studies and our group's previous research, sixty qualified PDS patients would be enrolled to conduct a prospective single-center randomized sham controlled clinical trial to verify the new therapeutic options that can improve symptoms and effectively slow the progression of the disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| muti-site stimulation group1 | Active comparator | Device: NeuromodulationThe intervention period: 2 weeks muti-site: individual target (iTBS OR cTBS) / M1 (iTBS) |
| single-site stimulation group2 | Active comparator | Device: NeuromodulationThe intervention period: 2 weeks muti-site: individual target (sham) / M1 (iTBS) |
| sham stimulation group3 | Sham comparator | Device: NeuromodulationThe intervention period: 2 weeks muti-site: individual target (sham) / M1 (sham) |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Compliance with the MDS revised clinical diagnostic criteria for Parkinsonian syndrome (2015 edition)
- aged >40 years and <80 years, regardless of gender.
- Patients were relatively stable during the study period and remained stable on medication
- Good compliance, written informed consent, and consent for NIBS long-term intervention treatment
Key exclusion criteria (7 listed)
- Patients with severe neuropsychiatric disorders or a previous history of severe neurologic conditions (e.g., epilepsy, cerebrovascular accident, etc.) or traumatic brain injury or brain surgery
- inability to complete the questionnaire independently
- Previous treatment with DBS or SCS; TMS or tDCS within 6 months
- Severe physical illness and any physical condition that can precipitate epilepsy or intracranial hypertension, including cardiovascular and respiratory diseases
- Installation of intracranial stents, pacemakers, coronary stents, cochlear implants, and other human implantable materials
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 |
|---|---|---|
| NeuromodulationNoninvasive brain stimulation (NIBS) includes a variety of noninvasive neuromodulation techniques such as transcranial magnetic stimulation (TMS), transcranial direct current stimulation (TDCS), and so on. Theta burst stimulation(TBS) is a new form of excitatory or inhibitory rTMS treatment that is less time-consuming and more effective than traditional rTMS in a single treatment session. | Device | muti-site stimulation group1, sham stimulation group3, single-site stimulation group2 |
Primary outcome
Group differences of part 3 of Unified Parkinson Disease Rating Scale (UPDRS) changes
Time frame: 6 weeks
Compare the changes in UPDRS scores from baseline to post- treatment in the three intervention groups (UPDRS part3: range 0~72, higher score is related to a worse outcome).
12 secondary outcomes
Group differences of Progressive Supranuclear Palsy Rating Scale (PSPRS)
Time frame: 6 weeks
Group differences of Unified Multiple System Atrophy Rating Scale (UMSARS)
Time frame: 6 weeks
Group differences of Cortical Basal ganglia Functional Scale (CBFS)
Time frame: 6 weeks
Group differences of Berg Balance Scale (BBS) changes
Time frame: 6 weeks
Group differences of Hamilton depression scale-17 (HAMD-17) changes
Time frame: 6 weeks
Group differences of Hamilton Anxiety Scale (HAMA) changes
Time frame: 6 weeks
Group differences of Mini-mental State Examination (MMSE) changes
Time frame: 6 weeks
Group differences of Montreal Cognitive Assessment (MoCA) changes
Time frame: 6 weeks
Group differences of 39-item Parkinson's Disease Questionnaire (PDQ-39) changes
Time frame: 6 weeks
Group differences of Wexner scores changes
Time frame: 6 weeks
Group differences of Standardized Swallowing Assessment (SSA) changes
Time frame: 6 weeks
Group differences of adverse event
Time frame: 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2024.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neuromodulation in people with Neuromodulation and Parkinsonian Syndromes, run by Ruijin 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 4 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 10 Jan 2024. 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 Jun Liu, Professor (64370045 ext. +86-021, jly0520@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Group differences of part 3 of Unified Parkinson Disease Rating Scale (UPDRS) changes (time frame: 6 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 10 Jan 2024.