Parkinson DiseaseNCT04996992
MRgFUS Pallidothalamic Tractotomy for Therapy-Resistant Parkinson's Disease
An observational study of Parkinson Disease and Magnetic Resonance Imaging, run by Chinese PLA General Hospital at 1 site in China.
Trial summary
To investigate the neural mechanism of Magnetic resonance-guided focused ultrasound (MRgFUS) Pallidothalamic Tractotomy in Parkinson's disease through multi-model MRI, and identify imaging biomarkers for triaging candidates and predicting the clinical outcomes. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Parkinson Disease, Magnetic Resonance Imaging
- What is being tested?
- MR-guided focused ultrasound
- Type of treatment
- Surgery or procedure
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- 15 Aug 2021to 15 Aug 2026
- Phase
- Observational
- 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 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with Parkinson's disease
Who may be able to join
- Regardless of sex, aged 30 or above, hope to treat bilateral motor symptoms and receive the other side treatment plan at the 6th month;
- Subjects are able and willing to give informed consent and can participate in whole study visits;
- It was clinically diagnosed as Parkinson's disease and confirmed by functional neurosurgeons;
- The subjects should respond to levodopa;
- In the off-medication state, the subjects' MDS-UPDRS scores were 30 or more.
Who cannot join
- The subjects scored 3 or more in the pull-back test;
- Parkinson's disease symptoms were suspected as the side effects of antipsychotics;
- severe cognitive impairment confirmed by neuropsychologists;
- subjects with other neurodegenerative diseases;
- Subjects with unstable mental illness, defined as active, uncontrolled depression, schizophrenia, delusions, hallucinations or suicide intention;
- Pregnant or lactating women;
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- Subjects with alcohol or drug abuse;
- Subjects with unstable heart condition or severe hypertension;
- Subjects with a history of abnormal bleeding or clotting.
Trial locations and contacts
1 site in 1 country.
Xin Lou, MD contact
China1 site
Chinese PLA General Hospital
Beijing, Beijing Municipality, 100853
Hao-xuan Lu, +86-13044270958, plaluhaoxuan@163.com
Xin Lou, MD
About this study
Official title: Multimodal Magnetic Resonance Imaging Study for MRgFUS Pallidothalamic Tractotomy for Therapy-Resistant Parkinson's Disease
To investigate the neural mechanism of Magnetic resonance-guided focused ultrasound (MRgFUS) Pallidothalamic Tractotomy in Parkinson's disease through multi-model MRI, and identify imaging biomarkers for triaging candidates and predicting the clinical outcomes.
Parkinson's disease (PD) is the second most progressive neurodegenerative disease with many motor and non-motor symptoms, which brings heavy burden to the family and the society.
MRgFUS pallidothalamic tractotomy allows to address all symptoms of PD without skull opening and with very limited tissue ablation, but with varying effectiveness. The unknown pathogenesis of PD has greatly contributed to this variance. Therefore, in order to optimize the clinical application of MRgFUS pallidothalamic tractotomy, it is important to reveal the pathogenesis of Parkinson's disease by using multiple modality MRI methods, and identify imaging biomarkers to triage suitable candidates and predict clinical outcomes.
Read the detailed description
Treatment scheme:
All patients will first receive uni- or bilateral MRgFUS PTT. As to bilateral interventions, the second one will take place at least 6 months after the first PTT. Patients with unilateral intervention will be followed to 1 year. Patients with bilateral interventions will be followed to 1 year after the second intervention. Baseline clinical demographics, Unified Parkinson Disease Rating Scale (UPDRS), treatment parameters (energy, power, duration time, temperature, target location) , associated adverse effects were recorded.
Imaging protocols:
T2; T2 Flair; DWI; ESWAN; MRS; 3D ASL 2.0s; 3D-T1; DTI; rs-functional MRI
Imaging evaluation:
- Lesion appearance and volume are measured by T2, T2 Flair, DWI, ESWAN, 3D-T1;
- ESWAN and MRS manifests the changes of iron deposition and metabolism, respectively;
- ASL shows regional cerebral blood flow associated with the procedure;
- DTI demonstrates the destruction of white matter integrity.
- Rs-functional MRI reflects alterations of resting-state brain activity.
Treatment:
MRgFUS pallidothalamic tractotomy
Follow-up:
MRI + clinical evaluation: Baseline, 3-day, 1-week, 1-month, 3-months, 6-months,12-months
- Conditions
- Parkinson Disease, Magnetic Resonance Imaging
- Being tested
- MR-guided focused ultrasound
- Keywords
- MR-guided focused ultrasound, pallidothalamic tractotomy
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MR-guided focused ultrasoundProcedure or surgery
MR-guided focused ultrasound pallidothalamic tractotomy is a minimally invasive and effective procedure for thetreatment of Parkinson's disease(PD) patients.
| Study group | Role | What they receive |
|---|---|---|
| Parkinson's disease | The cohort includes patients with Parkinson's disease who underwent MRgFUS pallidothalamic tractotomy (PTT). Receives: Procedure: MR-guided focused ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
primary efficacy outcome
The primary endpoints at 6 months and 1 year postoperatively were the Unified Parkinson's Disease Rating Scale (UPDRS) scores.
Measured: 1 year
primary safety outcome
Primary safety outcome was assessed by monitoring the incidence and severity of the procedure-related adverse events from the procedure through 1 year after treatment for all patients.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2021
- Study start15 Aug 2021 (estimated)
- Primary completion15 Aug 2023 (estimated)
- Study completion15 Aug 2026 (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 Chinese PLA General 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xin Lou, Chinese PLA General Hospital
- Investigators
- Xin Lou, MD, Study chair, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04996992
- Sponsor's protocol ID
- MRgFUS-PTT-PD
- Status last verified
- Jul 2021
- First submitted
- 31 Jul 2021
- Last updated
- 9 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multimodal Magnetic Resonance Imaging Study for MRgFUS Pallidothalamic Tractotomy for Therapy-Resistant Parkinson's Disease
- ClinicalTrials.gov ID
- NCT04996992
- Acronym / sponsor ID
- MRgFUS-PTT-PD
- Conditions
- Parkinson Disease, Magnetic Resonance Imaging
- Keywords
- MR-guided focused ultrasound, pallidothalamic tractotomy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- 15 Aug 2021 (estimated)
- Primary completion
- 15 Aug 2023 (estimated)
- Study completion
- 15 Aug 2026 (estimated)
- First posted
- 9 Aug 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.
To investigate the neural mechanism of Magnetic resonance-guided focused ultrasound (MRgFUS) Pallidothalamic Tractotomy in Parkinson's disease through multi-model MRI, and identify imaging biomarkers for triaging candidates and predicting the clinical outcomes.
Parkinson's disease (PD) is the second most progressive neurodegenerative disease with many motor and non-motor symptoms, which brings heavy burden to the family and the society.
MRgFUS pallidothalamic tractotomy allows to address all symptoms of PD without skull opening and with very limited tissue ablation, but with varying effectiveness. The unknown pathogenesis of PD has greatly contributed to this variance. Therefore, in order to optimize the clinical application of MRgFUS pallidothalamic tractotomy, it is important to reveal the pathogenesis of Parkinson's disease by using multiple modality MRI methods, and identify imaging biomarkers to triage suitable candidates and predict clinical outcomes.
Detailed description
Treatment scheme:
All patients will first receive uni- or bilateral MRgFUS PTT. As to bilateral interventions, the second one will take place at least 6 months after the first PTT. Patients with unilateral intervention will be followed to 1 year. Patients with bilateral interventions will be followed to 1 year after the second intervention. Baseline clinical demographics, Unified Parkinson Disease Rating Scale (UPDRS), treatment parameters (energy, power, duration time, temperature, target location) , associated adverse effects were recorded.
Imaging protocols:
T2; T2 Flair; DWI; ESWAN; MRS; 3D ASL 2.0s; 3D-T1; DTI; rs-functional MRI
Imaging evaluation:
- Lesion appearance and volume are measured by T2, T2 Flair, DWI, ESWAN, 3D-T1;
- ESWAN and MRS manifests the changes of iron deposition and metabolism, respectively;
- ASL shows regional cerebral blood flow associated with the procedure;
- DTI demonstrates the destruction of white matter integrity.
- Rs-functional MRI reflects alterations of resting-state brain activity.
Treatment:
MRgFUS pallidothalamic tractotomy
Follow-up:
MRI + clinical evaluation: Baseline, 3-day, 1-week, 1-month, 3-months, 6-months,12-months
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Parkinson's disease | – | Procedure: MR-guided focused ultrasoundThe cohort includes patients with Parkinson's disease who underwent MRgFUS pallidothalamic tractotomy (PTT). |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Parkinson's disease
Key inclusion criteria (5 listed)
- Regardless of sex, aged 30 or above, hope to treat bilateral motor symptoms and receive the other side treatment plan at the 6th month;
- Subjects are able and willing to give informed consent and can participate in whole study visits;
- It was clinically diagnosed as Parkinson's disease and confirmed by functional neurosurgeons;
- The subjects should respond to levodopa;
- In the off-medication state, the subjects' MDS-UPDRS scores were 30 or more.
Key exclusion criteria (9 listed)
- The subjects scored 3 or more in the pull-back test;
- Parkinson's disease symptoms were suspected as the side effects of antipsychotics;
- severe cognitive impairment confirmed by neuropsychologists;
- subjects with other neurodegenerative diseases;
- Subjects with unstable mental illness, defined as active, uncontrolled depression, schizophrenia, delusions, hallucinations or suicide intention;
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 |
|---|---|---|
| MR-guided focused ultrasoundMR-guided focused ultrasound pallidothalamic tractotomy is a minimally invasive and effective procedure for thetreatment of Parkinson's disease(PD) patients. | Procedure or surgery | Parkinson's disease |
Primary outcome
primary efficacy outcome
Time frame: 1 year
The primary endpoints at 6 months and 1 year postoperatively were the Unified Parkinson's Disease Rating Scale (UPDRS) scores.
primary safety outcome
Time frame: 1 year
Primary safety outcome was assessed by monitoring the incidence and severity of the procedure-related adverse events from the procedure through 1 year after treatment for all patients.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2021.
- Individual participant dataSharing planned: Undecided
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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.
Xin Lou, MD contact
Xin Lou, MD study chair
Chinese PLA General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson Disease and Magnetic Resonance Imaging, run by Chinese PLA General 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 9 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 9 Aug 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. 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 Hao-xuan Lu (+86-13044270958, plaluhaoxuan@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
primary efficacy outcome (time frame: 1 year). The study lists 2 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 9 Aug 2021.