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Deep Brain Therapy With Low-intensity Ultrasound for Generalized Chronic Pain

NCT05674903 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 47

Last updated 2025-05-25

No results posted yet for this study

Summary

This study will evaluate a new form of non-invasive deep brain therapy for individuals with generalized chronic pain. Low-intensity transcranial focused ultrasound stimulation will first be delivered using a range of stimulation parameters during psychophysical and physiological monitoring. A well-tolerated stimulation protocol will be selected for subsequent testing in a blinded randomized sham-controlled cross-over trial. The trial will evaluate brain target engagement using magnetic resonance imaging and CVAS and PROMIS numerical rating scales of pain.

Conditions

  • Chronic Pain
  • Chronic Pain Syndrome
  • Widespread Chronic Pain

Interventions

DEVICE

Verum stimulation with Diadem prototype

Diadem prototype device delivers focused low-intensity ultrasound stimulation

DEVICE

Sham stimulation with Diadem prototype

Diadem prototype device delivers active sham, unfocused low-intensity ultrasound stimulation

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2023-07-10
Primary Completion
2024-08-28
Completion
2024-08-28

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

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 NCT05674903 on ClinicalTrials.gov