Feasibility Study of ExAblate Thalamotomy for Treatment of Chronic Trigeminal Neuropathic Pain

NCT03309813 | Unknown Results DMC FDA Device

• 1 other identifier: NP002
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this prospective, randomized, sham-controlled, crossover study is to evaluate the safety and feasibility of ExAblate Neuro treatment of chronic trigeminal neuropathic pain.

Conditions

Trigeminal Neuropathic Pain

Keywords

ExAblate; TcMRgFUS; Thalamotomy

Outcome Measures

Primary Outcomes (2)

• Severity of Device and Procedure Related Complications

  To evaluate the incidence and severity of adverse events associated with ExAblate lesioning of the bilateral medial thalamus for painful neuropathies of the face and head that are severe and treatment-refractory.

  At the time of ExAblate Transcranial thalamotomy procedure through 3-months post-thalamotomy

• Numeric Pain Rating Scale (NPRS)

  Numeric Pain Rating Scale (NPRS) change in worst pain experienced over 24 hours before and at 3 months following bilateral FUS medial thalamotomy versus sham procedures was determined from the 11-point numeric pain rating scale with 0 as no pain and 10 the worst pain imaginable. High NPRS scores are worse pain (0 is no pain, 10 is maximum). Percent change from Baseline at Month 3 was calculated as follows: 100\*(NPRS Score at Baseline - NPRS Score at Month 3)/NPRS Score at Baseline. High percent change in NPRS Score from Baseline is better (improved pain).

  Percent Change in NPRS from before treatment to 3 Months following treatment.

Secondary Outcomes (1)

• Pain Interference Scale 8a v1.0 From the Patient-Reported Outcomes Measurement Information Systems (PROMIS) Pain Inventory

  From pre-treatment through 3 months following treatment.

Study Arms (2)

Transcranial ExAblate

EXPERIMENTAL

ExAblate Transcranial MR Guided Focused Ultrasound (MRgFUS)

Device: Transcranial ExAblate

Sham Transcranial ExAblate

SHAM COMPARATOR

ExAblate MRgFUS Sham Procedure

Device: Sham Transcranial ExAblate; Device: Crossover Transcranial Exablate

Interventions

Transcranial ExAblate DEVICE

ExAblate Thalamotomy for Chronic Trigeminal Neuropathic Pain

Also known as: MRgFUS, Thalamotomy

Transcranial ExAblate

Sham Transcranial ExAblate DEVICE

Sham ExAblate Thalamotomy procedure

Sham Transcranial ExAblate

Crossover Transcranial Exablate DEVICE

Subjects randomized to the Sham Exablate could opt for the Crossovover Transcranial Exablate Arm (Exablate Thalamotomy) after completing the Month 3 visit in the Sham Arm.

Also known as: MRgFUS, Thalamotomy

Sham Transcranial ExAblate

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women, between 18 and 75 years, inclusive
• Subjects who are able and willing to give consent and able to attend all study visits
• Severe chronic, trigeminal neuropathic pain of ≥6 months duration.
• Pain is medication-refractory to adequate trials of at least 3 prescription medications commonly used for symptomatic relief of neuropathic pain with current adjunctive use of at least one medication. An adequate medication trial is defined as a therapeutic dose of each medication without sufficient effect.
• Pain is treatment-resistant to at least one interventional therapies including injections, procedures, neuromodulation, and surgery.
• Able to communicate sensations during the focused ultrasound treatment
• Stable prescribed doses of all symptomatic pain medications for 30 days prior to study entry and for the duration of the 3-month blinded phase of the study.

You may not qualify if:

• Craniofacial pain syndromes related to malignancy of the head and neck
• Idiopathic trigeminal neuralgia
• Headache syndromes like migraine, cluster headache
• Temporomandibular joint syndrome
• Atypical facial pain or pain related to a somatoform disorder
• Subjects with active psychiatric illness will be excluded. For the purpose of this study, active psychiatric illness includes:
• Exhibiting current suicide ideation and/or a history of suicide attempt within past 2 years
• been hospitalized for the treatment of a psychiatric illness within the past 2 years
• received transcranial magnetic stimulation for depression treatment
• received electroconvulsive therapy for depression
• Any presence or history of psychosis will be excluded.
• Subjects with unstable cardiac status including:
• Unstable angina pectoris on medication
• Subjects with documented myocardial infarction within six months of protocol entry
• Significant congestive heart failure defined with ejection fraction \< 40

Sponsors & Collaborators

• InSightec: lead

Study Sites (1)

University of Virginia

Charlottesville, Virginia, 22908, United States

Location

Related Publications (1)

• Ishaque M, Moosa S, Urban L, Kundu B, Qureshi Z, Spears T, Fletcher PT, Donahue J, Patel SH, Goldstein RB, Finan PH, Liu CC, Elias WJ. Bilateral focused ultrasound medial thalamotomies for trigeminal neuropathic pain: a randomized controlled study. J Neurosurg. 2023 Dec 29;140(6):1799-1809. doi: 10.3171/2023.10.JNS23661. Print 2024 Jun 1.

  PMID: 38157521 DERIVED

Limitations and Caveats

This is a pilot study with limited sample size.

Results Point of Contact

• Title: Nadir Alikacem, VP Global Regulated Clinical Affairs
• Organization: Insightec

NadirA@Insightec.com

214-630-9900

Study Officials

• William J Elias, MD

  University of Virginia

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Subjects were randomized to an Exablate Test Arm or a Sham Control Arm. After completing the Month 3 Sham study visit, Sham Controls could elect to receive the actual Exablate ablation (same as test arm) and continue follow-up in a "Crossover Arm."

Study Record Dates

• First Submitted: October 5, 2017
• First Posted: October 16, 2017
• Study Start: December 1, 2017
• Primary Completion: October 1, 2023
• Study Completion: October 1, 2023
• Last Updated: October 3, 2023
• Results First Posted: October 3, 2023

Record last verified: 2022-12

Locations

US (1)