Multimodal MRI for MRgFUS Central Lateral Thalamotomy in Neuropathic Pain

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.

Study Overview

• Status: Recruiting
• Conditions: Neuropathic Pain; Magnetic Resonance Imaging
• Intervention / Treatment: Procedure: MRgFUS central lateral thalamotomy

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:

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

• Study Type: Observational
• Enrollment (Anticipated): 12

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China
      • Recruiting
      • Chinese PLA General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with Chronic Neuropathic Pain

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
FUS Thalamotomy; The cohort includes patients with neuropathic pain who underwent MRgFUS central lateral thalamotomy.	Procedure: MRgFUS central lateral thalamotomy; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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	1 years

Collaborators and Investigators

• Sponsor: Chinese PLA General Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): December 1, 2021
• Primary Completion (Anticipated): August 15, 2023
• Study Completion (Anticipated): July 15, 2026

Study Registration Dates

• First Submitted: July 31, 2021
• First Submitted That Met QC Criteria: November 15, 2021
• First Posted (Actual): November 16, 2021

Study Record Updates

• Last Update Posted (Actual): November 16, 2021
• Last Update Submitted That Met QC Criteria: November 15, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: MR-guided focused ultrasound; Central Lateral Nucleus of Thalamus
• Additional Relevant MeSH Terms: Nervous System Diseases; Pain; Neurologic Manifestations; Neuromuscular Diseases; Peripheral Nervous System Diseases; Neuralgia
• Other Study ID Numbers: MRgFUS-CL Neuropathic Pain

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No