Neuropathic PainNCT05122403
Multimodal MRI for MRgFUS Central Lateral Thalamotomy in Neuropathic Pain
An observational study of Neuropathic Pain and Magnetic Resonance Imaging, run by Chinese PLA General Hospital at 1 site in China.
Trial summary
To explore the pathogenesis underlying neuropathic pain as well as the mechanisms of pain relief after Magnetic resonance-guided focused ultrasound (MRgFUS) Central Lateral Thalamotomy through multi-model MRI study, and to identify imaging biomarkers for triaging patients and predicting the clinical outcomes. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Neuropathic Pain, Magnetic Resonance Imaging
- What is being tested?
- MRgFUS central lateral thalamotomy
- Type of treatment
- Surgery or procedure
- How many people
- 12 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2021to 15 Jul 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with Chronic Neuropathic Pain
Who may be able to join
- Male and female, aged between 18 and 75 (inclusive);
- Subjects who are able and willing to participate in the study;
- Chronic neuropathic pain with disease duration lasting more than 6 months;
- The worst NPRS score was ≥ 5 (out of 10), and the subjects reported a similar degree of pain in at least the past two months;
- Medication-refractory neuropathic pain with resistance to at least three kinds of neuropathic pain prescription drugs and one interventional procedure
Who cannot join
- Craniofacial pain syndrome associated with malignant tumors of the head and neck;
- Idiopathic trigeminal neuralgia;
- Headache syndrome, such as migraine;
- Temporomandibular joint syndrome;
- Atypical facial pain or pain related to somatoform disorders;
- Subjects are regarded as unqualified candidates by experts;
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- active mental illness;
- unstable heart state;
- severe hypertension (diastolic blood pressure after taking medicine >100mm/Hg)
- MR imaging standard contraindications, such as non-MRI compatible implanted metal devices, including pacemakers.
Trial locations and contacts
1 site in 1 country.
Xin Lou, MD contact
China1 site, 1 recruiting
- Recruiting
Chinese PLA General Hospital
Beijing, Beijing Municipality
Hao-xuan Lu, +86-13044270958, plaluhaoxuan@163.com
Xin Lou, MD
About this study
Official title: Multimodal Magnetic Resonance Imaging Study for Magnetic Resonance-Guided Focused Ultrasound Central Lateral Thalamotomy in Neuropathic Pain
To explore the pathogenesis underlying neuropathic pain as well as the mechanisms of pain relief after Magnetic resonance-guided focused ultrasound (MRgFUS) Central Lateral Thalamotomy through multi-model MRI study, and to identify imaging biomarkers for triaging patients and predicting the clinical outcomes. Craniofacial neuropathic pain is one of the most serious debilitating symptoms, leading to emotional disorders and poor quality of life. Previous studies have shown that Magnetic resonance-guided focused ultrasound (MRgFUS) central lateral thalamotomy is a minimally invasive and effective procedure for medication-refractory neuropathic pain patients. However, the clinical benefits were variable among individuals. It is important to clarify the pathogenesis of neuropathic pain and the mechanisms of pain relief induced by MRgFUS central lateral thalamotomy to triage suitable candidates for the procedure and predict clinical outcomes. In addition, localization precision and individualized treatment remain to be improved.
Read the detailed description
The study was designed as a prospective, sham-controlled randomized clinical trial (randomized 1:1) with double-blinded assessments through the 3-month primary end point analysis. Patients assigned to a sham procedure were offered open label treatment after the 3-month blinded assessment. All treated patients were followed unblinded to 1 year. Baseline clinical demographics, Numerical Pain Rating Scale (NPRS) 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 central lateral thalamotomy
Follow-up:
MRI + clinical evaluation：Baseline, 3-day, 1-month, 3-months, 6-months,12-months
- Conditions
- Neuropathic Pain, Magnetic Resonance Imaging
- Being tested
- MRgFUS central lateral thalamotomy
- Keywords
- MR-guided focused ultrasound, Central Lateral Nucleus of Thalamus
- Medical subject headings
- Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRgFUS central lateral thalamotomyProcedure or surgery
MRgFUS central lateral thalamotomy is a minimally invasive and effective procedure for medication-refractory neuropathic pain patients.
| Study group | Role | What they receive |
|---|---|---|
| FUS Thalamotomy | The cohort includes patients with neuropathic pain who underwent MRgFUS central lateral thalamotomy. Receives: Procedure: MRgFUS central lateral thalamotomy | |
| Sham Procedure | The cohort includes patients with neuropathic pain who underwent sham MRgFUS central lateral thalamotomy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
primary efficacy outcome（Numerical Pain Rating Scale score）
The primary efficacy outcome was determined by comparing the change from baseline to 3 months in the NPRS (Numerical Pain Rating Scale) score between FUS thalamotomy and sham procedures using intention-to-treat analysis.
Measured: 1 years
Primary safety outcome（incidence and severity of adverse events）
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 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2021
- Study start1 Dec 2021 (estimated)
- Primary completion15 Aug 2023 (estimated)
- Study completion15 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuropathic PainStudies 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-control
- Time perspective
- Prospective
- Enrolment
- 12 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
- NCT05122403
- Sponsor's protocol ID
- MRgFUS-CL Neuropathic Pain
- Status last verified
- Nov 2021
- First submitted
- 31 Jul 2021
- Last updated
- 16 Nov 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 16 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multimodal Magnetic Resonance Imaging Study for Magnetic Resonance-Guided Focused Ultrasound Central Lateral Thalamotomy in Neuropathic Pain
- ClinicalTrials.gov ID
- NCT05122403
- Acronym / sponsor ID
- MRgFUS-CL Neuropathic Pain
- Conditions
- Neuropathic Pain, Magnetic Resonance Imaging
- Keywords
- MR-guided focused ultrasound, Central Lateral Nucleus of Thalamus
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- 1 Dec 2021 (estimated)
- Primary completion
- 15 Aug 2023 (estimated)
- Study completion
- 15 Jul 2026 (estimated)
- First posted
- 16 Nov 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 explore the pathogenesis underlying neuropathic pain as well as the mechanisms of pain relief after Magnetic resonance-guided focused ultrasound (MRgFUS) Central Lateral Thalamotomy through multi-model MRI study, and to identify imaging biomarkers for triaging patients and predicting the clinical outcomes. Craniofacial neuropathic pain is one of the most serious debilitating symptoms, leading to emotional disorders and poor quality of life. Previous studies have shown that Magnetic resonance-guided focused ultrasound (MRgFUS) central lateral thalamotomy is a minimally invasive and effective procedure for medication-refractory neuropathic pain patients. However, the clinical benefits were variable among individuals. It is important to clarify the pathogenesis of neuropathic pain and the mechanisms of pain relief induced by MRgFUS central lateral thalamotomy to triage suitable candidates for the procedure and predict clinical outcomes. In addition, localization precision and individualized treatment remain to be improved.
Detailed description
The study was designed as a prospective, sham-controlled randomized clinical trial (randomized 1:1) with double-blinded assessments through the 3-month primary end point analysis. Patients assigned to a sham procedure were offered open label treatment after the 3-month blinded assessment. All treated patients were followed unblinded to 1 year. Baseline clinical demographics, Numerical Pain Rating Scale (NPRS) 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 central lateral thalamotomy
Follow-up:
MRI + clinical evaluation：Baseline, 3-day, 1-month, 3-months, 6-months,12-months
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FUS Thalamotomy | – | Procedure: MRgFUS central lateral thalamotomyThe cohort includes patients with neuropathic pain who underwent MRgFUS central lateral thalamotomy. |
| Sham Procedure | – | –The cohort includes patients with neuropathic pain who underwent sham MRgFUS central lateral thalamotomy. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Chronic Neuropathic Pain
Key inclusion criteria (5 listed)
- Male and female, aged between 18 and 75 (inclusive);
- Subjects who are able and willing to participate in the study;
- Chronic neuropathic pain with disease duration lasting more than 6 months;
- The worst NPRS score was ≥ 5 (out of 10), and the subjects reported a similar degree of pain in at least the past two months;
- Medication-refractory neuropathic pain with resistance to at least three kinds of neuropathic pain prescription drugs and one interventional procedure
Key exclusion criteria (10 listed)
- Craniofacial pain syndrome associated with malignant tumors of the head and neck;
- Idiopathic trigeminal neuralgia;
- Headache syndrome, such as migraine;
- Temporomandibular joint syndrome;
- Atypical facial pain or pain related to somatoform disorders;
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 |
|---|---|---|
| MRgFUS central lateral thalamotomyMRgFUS central lateral thalamotomy is a minimally invasive and effective procedure for medication-refractory neuropathic pain patients. | Procedure or surgery | FUS Thalamotomy |
Primary outcome
primary efficacy outcome（Numerical Pain Rating Scale score）
Time frame: 1 years
The primary efficacy outcome was determined by comparing the change from baseline to 3 months in the NPRS (Numerical Pain Rating Scale) score between FUS thalamotomy and sham procedures using intention-to-treat analysis.
Primary safety outcome（incidence and severity of adverse events）
Time frame: 1 years
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 16 Nov 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 Neuropathic Pain 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 10 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 16 Nov 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（Numerical Pain Rating Scale score） (time frame: 1 years). 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 16 Nov 2021.