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Low Intensity Focused Ultrasound Modulation of Thalamic Nuclei for Central Neuropathic Pain.

NCT06978764 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2025-05-18

No results posted yet for this study

Summary

LIFUP may have a modulatory effect on neuronal circuitry involved in pain, specifically when applied to the anterior thalamic nuclei, which is an important part of the pain circuit .Precise laboratory studies will reveal the indications under which LIFUP produces analgesia. The first step in evaluating LIFUP as a therapy for pain control is to determine whether LIFUP produces analgesia through suppression of the anterior thalamus. The primary objective is to evaluate the short-term analgesic effects of thalamic analgesia caused by LIFUP through:

1. Quantitative sensory testing (QST) and conditioned pain modulation testing (CPM) that allow the assessment of perceptual responses to quantifiable sensory stimuli, evaluated to characterize somatosensory function or dysfunction.
2. Short-form McGill Pain Questionnaire;
3. Brief Inventory Form, which includes pain severity index (average of questions 3-6) and pain interference with daily activities (average of questions 9A-9G, ranging from 0 to 70, where 70 indicates maximum possible pain interference);
4. Douleur Neuropathique-4 to assess neuropathic pain, being positive for scores ≥4;
5. Neuropathic Pain Symptom Inventory (NPSI), which provides characterization of neuropathic pain symptoms in 5 domains (superficial and deep) spontaneous pain, paroxysmal pain, evoked pain and paresthesia.

In association, analysis of its responses with others qualitative scales will be made described above:

1. Hamilton D + A
2. Medication use (Brief Pain Inventory)
3. Interference with daily activities (Brief Pain Inventory, quantified by Medication Quantification Scale)
4. Cognition - Montreal Cognitive Assessment (Mo CA)5 Adverse events
5. Blinding assessment
6. Variation in Global Impression of Change (CGI)

Conditions

  • Central Neuropathic Pain

Interventions

PROCEDURE

Thalamic LIFUP

Patients will receive intervention in Thalamus region by LIFUP

Sponsors & Collaborators

  • University of Sao Paulo

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-19
Primary Completion
2025-12-31
Completion
2026-04-25

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06978764 on ClinicalTrials.gov