Trial Outcomes & Findings for Feasibility Study of ExAblate Thalamotomy for Treatment of Chronic Trigeminal Neuropathic Pain (NCT NCT03309813)

Last Updated: 2023-10-03

Results Overview

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.

Recruitment status

UNKNOWN

Study phase

Target enrollment

10 participants

Primary outcome timeframe

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

Results posted on

2023-10-03

Participant Flow

Participant milestones

Participant milestones
Measure	Transcranial ExAblate (MRgFUS) Only ExAblate Transcranial MR Guided Focused Ultrasound (MRgFUS) Transcranial ExAblate: ExAblate Thalamotomy for Chronic Trigeminal Neuropathic Pain	Sham Transcranial ExAblate First, Then Optional Transcranial Exablate (MRgFUS) ExAblate MRgFUS Sham Procedure Sham Transcranial ExAblate: Sham ExAblate Thalamotomy procedure
Main Randomized Study STARTED	5	5
Main Randomized Study COMPLETED	4	5
Main Randomized Study NOT COMPLETED	1	0
Crossover Transcranial Exablate STARTED	0	3
Crossover Transcranial Exablate COMPLETED	0	3
Crossover Transcranial Exablate NOT COMPLETED	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Transcranial ExAblate (MRgFUS) Only ExAblate Transcranial MR Guided Focused Ultrasound (MRgFUS) Transcranial ExAblate: ExAblate Thalamotomy for Chronic Trigeminal Neuropathic Pain	Sham Transcranial ExAblate First, Then Optional Transcranial Exablate (MRgFUS) ExAblate MRgFUS Sham Procedure Sham Transcranial ExAblate: Sham ExAblate Thalamotomy procedure
Main Randomized Study Withdrawal by Subject	1	0

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Transcranial ExAblate (MRgFUS) Only n=5 Participants ExAblate Transcranial MR Guided Focused Ultrasound (MRgFUS) Transcranial ExAblate: ExAblate Thalamotomy for Chronic Trigeminal Neuropathic Pain	Sham Transcranial ExAblate First, Then Optional Transcranial ExAblate (MRgFUS) n=5 Participants ExAblate MRgFUS Sham Procedure Sham Transcranial ExAblate: Sham ExAblate Thalamotomy procedure Crossover Transcranial Exablate: 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.	Total n=10 Participants Total of all reporting groups
Sex: Female, Male Female	3 Participants n=5 Participants	5 Participants n=7 Participants	8 Participants n=5 Participants
Age, Continuous Age	64.3 years STANDARD_DEVIATION 8.9 • n=5 Participants	59.6 years STANDARD_DEVIATION 7.9 • n=7 Participants	62.0 years STANDARD_DEVIATION 8.3 • n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	5 Participants n=5 Participants	5 Participants n=7 Participants	10 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	5 participants n=5 Participants	5 participants n=7 Participants	10 participants n=5 Participants

PRIMARY outcome

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

Outcome measures

Outcome data not reported

PRIMARY outcome

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

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).

Outcome measures

Outcome measures
Measure	Transcranial ExAblate (MRgFUS) Only n=5 Participants ExAblate Transcranial MR Guided Focused Ultrasound (MRgFUS) Transcranial ExAblate: ExAblate Thalamotomy for Chronic Trigeminal Neuropathic Pain	Sham Transcranial ExAblate First n=5 Participants ExAblate MRgFUS Sham Procedure Sham Transcranial ExAblate: Sham ExAblate Thalamotomy procedure	Optional Crossover Transcranial Exablate (MRgFUS) n=3 Participants After completing the 3 Month Visit sham subjects were given the opportunity to receive the Exablate treatment and continue follow-up in the Crossover Group.
Numeric Pain Rating Scale (NPRS)	-9.7 Percent change Standard Deviation 27.4	12.9 Percent change Standard Deviation 21.7	4.8 Percent change Standard Deviation 8.3

SECONDARY outcome

Timeframe: From pre-treatment through 3 months following treatment.

The Pain Interference 8a v1.0 Scale (Short Form) from the Patient-Reported Outcomes Measurement Information Systems (PROMIS) Pain Inventory is an 8-item patient completed short form with each item on a 5-point scale (0-4). The total score possible ranges from 0-32. The PROMIS pain interference scale measures the degree to which pain interferes with activities of daily living. A high percent change from Baseline at 3 Months post-treatment is better, shows improvement.

Outcome measures

Outcome measures
Measure	Transcranial ExAblate (MRgFUS) Only n=5 Participants ExAblate Transcranial MR Guided Focused Ultrasound (MRgFUS) Transcranial ExAblate: ExAblate Thalamotomy for Chronic Trigeminal Neuropathic Pain	Sham Transcranial ExAblate First n=5 Participants ExAblate MRgFUS Sham Procedure Sham Transcranial ExAblate: Sham ExAblate Thalamotomy procedure	Optional Crossover Transcranial Exablate (MRgFUS) n=3 Participants After completing the 3 Month Visit sham subjects were given the opportunity to receive the Exablate treatment and continue follow-up in the Crossover Group.
Pain Interference Scale 8a v1.0 From the Patient-Reported Outcomes Measurement Information Systems (PROMIS) Pain Inventory	12.9 Percent Change Standard Deviation 28.3	16.6 Percent Change Standard Deviation 30.5	54.7 Percent Change Standard Deviation 40.1

Adverse Events

Transcranial ExAblate (MRgFUS)

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Sham Transcranial ExAblate First

Serious events: 1 serious events

Other events: 5 other events

Deaths: 0 deaths

Optional Crossover Transcranial Exablate (MRgFUS)

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Transcranial ExAblate (MRgFUS) n=5 participants at risk ExAblate Transcranial MR Guided Focused Ultrasound (MRgFUS) Transcranial ExAblate: ExAblate Thalamotomy for Chronic Trigeminal Neuropathic Pain	Sham Transcranial ExAblate First n=5 participants at risk ExAblate MRgFUS Sham Procedure Sham Transcranial ExAblate: Sham ExAblate Thalamotomy procedure	Optional Crossover Transcranial Exablate (MRgFUS) n=3 participants at risk After completing the 3 Month Visit sham subjects were given the opportunity to receive the Exablate treatment and continue follow-up in the Crossover Group.
General disorders Worsening pain	0.00% 0/5 • Adverse event data were collected though 3 months post-thalamotomy.	20.0% 1/5 • Number of events 1 • Adverse event data were collected though 3 months post-thalamotomy.	0.00% 0/3 • Adverse event data were collected though 3 months post-thalamotomy.

Other adverse events

Other adverse events
Measure	Transcranial ExAblate (MRgFUS) n=5 participants at risk ExAblate Transcranial MR Guided Focused Ultrasound (MRgFUS) Transcranial ExAblate: ExAblate Thalamotomy for Chronic Trigeminal Neuropathic Pain	Sham Transcranial ExAblate First n=5 participants at risk ExAblate MRgFUS Sham Procedure Sham Transcranial ExAblate: Sham ExAblate Thalamotomy procedure	Optional Crossover Transcranial Exablate (MRgFUS) n=3 participants at risk After completing the 3 Month Visit sham subjects were given the opportunity to receive the Exablate treatment and continue follow-up in the Crossover Group.
General disorders Fatigue	20.0% 1/5 • Number of events 1 • Adverse event data were collected though 3 months post-thalamotomy.	0.00% 0/5 • Adverse event data were collected though 3 months post-thalamotomy.	0.00% 0/3 • Adverse event data were collected though 3 months post-thalamotomy.
General disorders Sleepiness	20.0% 1/5 • Number of events 1 • Adverse event data were collected though 3 months post-thalamotomy.	0.00% 0/5 • Adverse event data were collected though 3 months post-thalamotomy.	0.00% 0/3 • Adverse event data were collected though 3 months post-thalamotomy.
General disorders Headache	20.0% 1/5 • Number of events 1 • Adverse event data were collected though 3 months post-thalamotomy.	0.00% 0/5 • Adverse event data were collected though 3 months post-thalamotomy.	0.00% 0/3 • Adverse event data were collected though 3 months post-thalamotomy.
General disorders Cold sensation	20.0% 1/5 • Number of events 1 • Adverse event data were collected though 3 months post-thalamotomy.	0.00% 0/5 • Adverse event data were collected though 3 months post-thalamotomy.	0.00% 0/3 • Adverse event data were collected though 3 months post-thalamotomy.
General disorders Sonication pain	20.0% 1/5 • Number of events 1 • Adverse event data were collected though 3 months post-thalamotomy.	0.00% 0/5 • Adverse event data were collected though 3 months post-thalamotomy.	33.3% 1/3 • Number of events 1 • Adverse event data were collected though 3 months post-thalamotomy.
Musculoskeletal and connective tissue disorders Unsteadiness	20.0% 1/5 • Number of events 1 • Adverse event data were collected though 3 months post-thalamotomy.	0.00% 0/5 • Adverse event data were collected though 3 months post-thalamotomy.	0.00% 0/3 • Adverse event data were collected though 3 months post-thalamotomy.
General disorders Tight sensation	20.0% 1/5 • Number of events 1 • Adverse event data were collected though 3 months post-thalamotomy.	0.00% 0/5 • Adverse event data were collected though 3 months post-thalamotomy.	0.00% 0/3 • Adverse event data were collected though 3 months post-thalamotomy.
Surgical and medical procedures Facial edema	20.0% 1/5 • Number of events 1 • Adverse event data were collected though 3 months post-thalamotomy.	0.00% 0/5 • Adverse event data were collected though 3 months post-thalamotomy.	0.00% 0/3 • Adverse event data were collected though 3 months post-thalamotomy.
Gastrointestinal disorders Nausea/vomiting	0.00% 0/5 • Adverse event data were collected though 3 months post-thalamotomy.	20.0% 1/5 • Number of events 1 • Adverse event data were collected though 3 months post-thalamotomy.	66.7% 2/3 • Number of events 2 • Adverse event data were collected though 3 months post-thalamotomy.
Gastrointestinal disorders Numbness/tingling	0.00% 0/5 • Adverse event data were collected though 3 months post-thalamotomy.	20.0% 1/5 • Number of events 1 • Adverse event data were collected though 3 months post-thalamotomy.	33.3% 1/3 • Number of events 1 • Adverse event data were collected though 3 months post-thalamotomy.
General disorders Transient headache	0.00% 0/5 • Adverse event data were collected though 3 months post-thalamotomy.	40.0% 2/5 • Number of events 2 • Adverse event data were collected though 3 months post-thalamotomy.	0.00% 0/3 • Adverse event data were collected though 3 months post-thalamotomy.
Skin and subcutaneous tissue disorders Head pain	0.00% 0/5 • Adverse event data were collected though 3 months post-thalamotomy.	20.0% 1/5 • Number of events 1 • Adverse event data were collected though 3 months post-thalamotomy.	33.3% 1/3 • Number of events 1 • Adverse event data were collected though 3 months post-thalamotomy.
Skin and subcutaneous tissue disorders Pin site pain	0.00% 0/5 • Adverse event data were collected though 3 months post-thalamotomy.	20.0% 1/5 • Number of events 1 • Adverse event data were collected though 3 months post-thalamotomy.	0.00% 0/3 • Adverse event data were collected though 3 months post-thalamotomy.

Additional Information

Nadir Alikacem, VP Global Regulated Clinical Affairs

Insightec

Phone: 214-630-9900

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place