NCT03111277

MR Guided Focused Ultrasound for Treatment of Neuropathic Pain

Completed NA Last updated 12 October 2022

What this trial tests

NA trial testing Experimental: ExAblate Transcranial treatment in Severe Neuropathic Pain Due to Radiculopathy or Radicular Injury in 10 participants. Completed in 9 October 2022.

Timeline

15 September 2017

Primary endpoint
9 October 2022

9 October 2022

Quick facts

Lead sponsor	University of Maryland, Baltimore
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	device feasibility
Enrollment	10
Start date	15 September 2017
Primary completion	9 October 2022
Estimated completion	9 October 2022
Sites	1 location across United States

Drugs / interventions tested

• Experimental: ExAblate Transcranial treatment

Conditions studied

• Severe Neuropathic Pain Due to Radiculopathy or Radicular Injury — all drugs for Severe Neuropathic Pain Due to Radiculopathy or Radicular Injury →
• Spinal Cord Injuries — all drugs for Spinal Cord Injuries →
• Phantom Limb Pain — all drugs for Phantom Limb Pain →

Sponsor

University of Maryland, Baltimore

Who can join

Adults 21 to 75, any sex, with Severe Neuropathic Pain Due to Radiculopathy or Radicular Injury or Spinal Cord Injuries. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Neuropathic pain is often a result of direct diseases of peripheral or central nervous system with an estimated prevalence of 8% of adults and this pain is associated with significant consequences because of longer symptom duration and severity than many of the other pain syndromes. Functional brain imaging has revealed that many regions of the brain are engaged by painful events, but specific areas such as the thalamus have been markedly implicated.

The purpose of this study is to determine the feasibility and safety of MRI-guided focused ultrasound treatment using the ExAblate Transcranial System in patients suffering from Neuropathic pain. This treatment modality offers non-invasive precise treatment potential for these patients.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. High-Intensity Focused Ultrasound: A Review of Mechanisms and Clinical Applications.
   Bachu VS, Kedda J, Suk I, Green JJ, et al · · 2021 · cited 166× · PMID 34374945 · DOI 10.1007/s10439-021-02833-9
2. Focused Ultrasound (FUS) for Chronic Pain Management: Approved and Potential Applications.
   di Biase L, Falato E, Caminiti ML, Pecoraro PM, et al · · 2021 · cited 37× · PMID 34258062 · DOI 10.1155/2021/8438498
3. Current and emerging brain applications of MR-guided focused ultrasound.
   Meng Y, Suppiah S, Mithani K, Solomon B, et al · · 2017 · cited 29× · PMID 29034095 · DOI 10.1186/s40349-017-0105-z
4. Current state of clinical ultrasound neuromodulation.
   Matt E, Radjenovic S, Mitterwallner M, Beisteiner R. · · 2024 · cited 27× · PMID 38962179 · DOI 10.3389/fnins.2024.1420255
5. Magnetic Resonance-Guided Focused Ultrasound in Neurosurgery: Taking Lessons from the Past to Inform the Future.
   Jung NY, Chang JW. · · 2018 · cited 24× · PMID 30369860 · DOI 10.3346/jkms.2018.33.e279
6. MRI Guided Focused Ultrasound-Mediated Delivery of Therapeutic Cells to the Brain: A Review of the State-of-the-Art Methodology and Future Applications.
   Ahmed N, Gandhi D, Melhem ER, Frenkel V. · · 2021 · cited 18× · PMID 34220679 · DOI 10.3389/fneur.2021.669449
7. Targeted manipulation of pain neural networks: The potential of focused ultrasound for treatment of chronic pain.
   Todd N, McDannold N, Borsook D. · · 2020 · cited 13× · PMID 32534900 · DOI 10.1016/j.neubiorev.2020.06.007
8. Review of the Treatments for Central Neuropathic Pain.
   Sheldon BL, Olmsted ZT, Sabourin S, Heydari E, et al · · 2022 · cited 12× · PMID 36552186 · DOI 10.3390/brainsci12121727