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Multimodal MRI for MRgFUS Central Lateral Thalamotomy in Neuropathic Pain

NCT ID: NCT05122403

Last Updated: 2021-11-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

12 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-12-01

Study Completion Date

2026-07-15

Brief Summary

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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

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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:

1. Lesion appearance and volume are measured by T2, T2 Flair, DWI, ESWAN, 3D-T1;
2. ESWAN and MRS manifests the changes of iron deposition and metabolism, respectively;
3. ASL shows regional cerebral blood flow associated with the procedure;
4. DTI demonstrates the destruction of white matter integrity.
5. 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

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Neuropathic Pain Magnetic Resonance Imaging

Keywords

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MR-guided focused ultrasound Central Lateral Nucleus of Thalamus

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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FUS Thalamotomy

The cohort includes patients with neuropathic pain who underwent MRgFUS central lateral thalamotomy.

MRgFUS central lateral thalamotomy

Intervention Type PROCEDURE

MRgFUS central lateral thalamotomy is a minimally invasive and effective procedure for medication-refractory neuropathic pain patients.

Sham Procedure

The cohort includes patients with neuropathic pain who underwent sham MRgFUS central lateral thalamotomy.

No interventions assigned to this group

Interventions

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MRgFUS central lateral thalamotomy

MRgFUS central lateral thalamotomy is a minimally invasive and effective procedure for medication-refractory neuropathic pain patients.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

1. Male and female, aged between 18 and 75 (inclusive);
2. Subjects who are able and willing to participate in the study;
3. Chronic neuropathic pain with disease duration lasting more than 6 months;
4. 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;
5. Medication-refractory neuropathic pain with resistance to at least three kinds of neuropathic pain prescription drugs and one interventional procedure

Exclusion Criteria

1. Craniofacial pain syndrome associated with malignant tumors of the head and neck;
2. Idiopathic trigeminal neuralgia;
3. Headache syndrome, such as migraine;
4. Temporomandibular joint syndrome;
5. Atypical facial pain or pain related to somatoform disorders;
6. Subjects are regarded as unqualified candidates by experts;
7. active mental illness;
8. unstable heart state;
9. severe hypertension (diastolic blood pressure after taking medicine \>100mm/Hg)
10. MR imaging standard contraindications, such as non-MRI compatible implanted metal devices, including pacemakers.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chinese PLA General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Xin Lou

Deputy Director of Department of Radiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Xin Lou, MD

Role: STUDY_CHAIR

Chinese PLA General Hospital

Locations

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Chinese PLA General Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Hao-xuan Lu

Role: CONTACT

Phone: +86-13044270958

Email: [email protected]

Xin Lou, MD

Role: CONTACT

Phone: +86-13044270958

Facility Contacts

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Hao-xuan Lu

Role: primary

Xin Lou, MD

Role: backup

Other Identifiers

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MRgFUS-CL Neuropathic Pain

Identifier Type: -

Identifier Source: org_study_id