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

NCT06978764 | Active Not Recruiting Phase 1

• 1 other identifier: 35818919600000068
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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. 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. 2.Short-form McGill Pain Questionnaire;
3. 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. 4.Douleur Neuropathique-4 to assess neuropathic pain, being positive for scores ≥4;
5. 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.
6. 6.Hamilton D + A
7. 7.Medication use (Brief Pain Inventory)
8. 8.Interference with daily activities (Brief Pain Inventory, quantified by Medication Quantification Scale)
9. 9.Cognition - Montreal Cognitive Assessment (Mo CA)5 Adverse events
10. 10.Blinding assessment
11. 11.Variation in Global Impression of Change (CGI)

Conditions

Central Neuropathic Pain

Keywords

plexo braquial

Outcome Measures

Primary Outcomes (1)

• Pain assessments

  Pain scores in Visual Analog Scale has a numeric scoring that measures the intensity of pain from a scale of 1 to 10. The higher numeric scoring of the scale suggests severity and worse pain sensations. The scale will be analyzed before and after application of low-intensity pulsed ultrasound on the anterior thalamus.

  Before and immediately after intervention. Also 4 hours, 24 hours, 10 days and 28 days after intervention.

Secondary Outcomes (1)

• Somatosensory system analysis

  Before intervention as well as immediately after and 28 days after intervention

Other Outcomes (4)

• Conditioned Pain Modulation

  Before and immediately after intervention and after 28 days after intervention.

• Neuropathic pain assessment

  Before intervention as well as immediately after and 28 days after intervention

• Depression and Anxiety analysis

  Before and after 28 days of intervention.

Study Arms (2)

Active

ACTIVE COMPARATOR

Patients receiveing Thalamic LIFUP intervention

Procedure: Thalamic LIFUP

Sham

SHAM COMPARATOR

Patients receiveing Thalamic Sham intervention

Procedure: Thalamic LIFUP

Interventions

Thalamic LIFUP PROCEDURE

Patients will receive intervention in Thalamus region by LIFUP

Active; Sham

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female more than 18 years old;
• Persistent presence of pain from braquial plexopathy injury for more than 3 months with an average of pain scoring of four or more points in numeric verbal scale (refractory to treatments).

You may not qualify if:

• history of uncontrolled epilepsy
• history of depression
• surgery or hospitalizations in the last 6 months
• presence of metal brain implants
• history of alcohol or drug addiction
• pregnancy
• history of loss of consciousness lasting more than 15 minutes

Sponsors & Collaborators

• University of Sao Paulo: lead

Study Sites (1)

Neurology Department HCFMUSP

São Paulo, São Paulo, 05403000, Brazil

Location

Related Publications (12)

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Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 10, 2025
• First Posted: May 18, 2025
• Study Start: November 19, 2024
• Primary Completion: December 31, 2025
• Study Completion: April 25, 2026
• Last Updated: May 18, 2025

Record last verified: 2025-05

Locations

BR (1)