Trial Outcomes & Findings for ExAblate Transcranial MR Guided Focused Ultrasound for the Treatment of Essential Tremors (NCT NCT01827904)

Last Updated: 2024-08-27

Results Overview

The percent change from baseline to Month 3 follow-up in upper extremity Tremor-Motor scores for the treated side is a sub-scale of Clinical Rating Scale for Tremor (CRST) Part A and Part B sum that was used to measure treated-side upper extremity tremor changes over time. Tremor-motor scores range from 0-32 points. Individual subject's scores at Baseline and 3 Months were used to calculate percent change from baseline and averaged across subjects. High percent change from baseline is better (shows improvement).

Recruitment status

COMPLETED

Study phase

Target enrollment

76 participants

Primary outcome timeframe

Baseline, 3 Months post-treatment

Results posted on

2024-08-27

Participant Flow

After completing the 3 Month visit subjects randomized to the Sham group were given the option to receive the Exablate thalamotomy as a rescue treatment and continue in the Crossover group. Nineteen subjects opted to continue in the Crossover group. Thus, 19 Sham Control and 19 Crossover are the same subjects. Two subjects randomized to the Exablate test group received suboptimal treatment, were retreated, and followed in the Crossover group through 12 Months resulting in N = 21.

Participant milestones

Participant milestones
Measure	Transcranial Exablate (MRgFUS) Only The experimental design is a two-arm Test versus Sham Control study. The primary efficacy analysis was performed at Month-3 post treatment. Test arm: Transcranial Exablate subjects randomly assigned to the MR guided Focused Ultrasound (MRgFUS) test arm. Transcranial Exablate: Exablate thalamotomy for essential tremor.	Sham Transcranial Exablate First, Then Optional Transcranial Exablate (MRgFUS) The experimental design was a two-arm Test versus Sham treatment. Sham arm: Sham Treatment with Transcranial Exablate subjects randomly assigned to the sham control arm. After completing the 3-Month study visit sham treatment control subjects could be offered the Exablate procedure as a "rescue" treatment and follow-up in the Crossover arm. This "crossover" was not a formal part of the experimental design in terms of hypothesis testing. It was analyzed separately as supplemental efficacy and safety data. Sham Transcranial Exablate: Exablate procedure with ultrasound energy set to zero.	Crossover Transcranial Exablate After 3-Month Follow-Up After completing the 3 Month visit subjects randomized to the Sham group were presented with the opportunity to receive the Exablate as a "rescue" treatment and continue in the study in the Crossover group. Nineteen subjects opted to continue in the Crossover ("rescue") group. Two subjects randomized to the Exablate test group received suboptimal treatment, were retreated, and followed in the Crossover group. Thus the total number of subjects in the initially in the Crossover group was 21.
Main Study STARTED	56	20	0
Main Study COMPLETED	54	20	0
Main Study NOT COMPLETED	2	0	0
Main Continuation / Crossover Phase STARTED	54	0	21
Main Continuation / Crossover Phase COMPLETED	51	0	21
Main Continuation / Crossover Phase NOT COMPLETED	3	0	0
Long-term Annual Follow-up STARTED	51	0	19
Long-term Annual Follow-up COMPLETED	29	0	12
Long-term Annual Follow-up NOT COMPLETED	22	0	7

Reasons for withdrawal

Reasons for withdrawal
Measure	Transcranial Exablate (MRgFUS) Only The experimental design is a two-arm Test versus Sham Control study. The primary efficacy analysis was performed at Month-3 post treatment. Test arm: Transcranial Exablate subjects randomly assigned to the MR guided Focused Ultrasound (MRgFUS) test arm. Transcranial Exablate: Exablate thalamotomy for essential tremor.	Crossover Transcranial Exablate After 3-Month Follow-Up After completing the 3 Month visit subjects randomized to the Sham group were presented with the opportunity to receive the Exablate as a "rescue" treatment and continue in the study in the Crossover group. Nineteen subjects opted to continue in the Crossover ("rescue") group. Two subjects randomized to the Exablate test group received suboptimal treatment, were retreated, and followed in the Crossover group. Thus the total number of subjects in the initially in the Crossover group was 21.
Main Study Withdrawal by Subject	1	0
Main Study Adverse Event	1	0
Main Continuation / Crossover Phase Alternative treatment	1	0
Main Continuation / Crossover Phase Withdrawal by Subject	1	0
Main Continuation / Crossover Phase Health reasons unrelated to study	1	0
Long-term Annual Follow-up Withdrawal by Subject	11	5
Long-term Annual Follow-up Alternative Treatment	4	1
Long-term Annual Follow-up Unrelated Health Reason	2	1
Long-term Annual Follow-up Lost to Follow-up	2	0
Long-term Annual Follow-up Physician Decision	1	0
Long-term Annual Follow-up Lack of Efficacy	1	0
Long-term Annual Follow-up Suboptimal Treatment	1	0

Baseline Characteristics

ExAblate Transcranial MR Guided Focused Ultrasound for the Treatment of Essential Tremors

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Transcranial ExAblate n=56 Participants Transcranial ExAblate Transcranial ExAblate	Sham Transcranial ExAblate n=20 Participants Sham Treatment with Transcranial ExAblate Sham Transcranial ExAblate	Total n=76 Participants Total of all reporting groups
Age, Continuous	70.8 years STANDARD_DEVIATION 8.7 • n=5 Participants	71.4 years STANDARD_DEVIATION 7.3 • n=7 Participants	71.0 years STANDARD_DEVIATION 8.3 • n=5 Participants
Sex: Female, Male Female	19 Participants n=5 Participants	5 Participants n=7 Participants	24 Participants n=5 Participants
Sex: Female, Male Male	37 Participants n=5 Participants	15 Participants n=7 Participants	52 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	41 Participants n=5 Participants	16 Participants n=7 Participants	57 Participants n=5 Participants
Race/Ethnicity, Customized Black	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized Asian	14 Participants n=5 Participants	4 Participants n=7 Participants	18 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized Other	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment Canada	12 participants n=5 Participants	4 participants n=7 Participants	16 participants n=5 Participants
Region of Enrollment South Korea	12 participants n=5 Participants	3 participants n=7 Participants	15 participants n=5 Participants
Region of Enrollment United States	32 participants n=5 Participants	13 participants n=7 Participants	45 participants n=5 Participants
Skull Density Ratio	0.6 Ratio STANDARD_DEVIATION 0.1 • n=5 Participants	0.5 Ratio STANDARD_DEVIATION 0.1 • n=7 Participants	0.6 Ratio STANDARD_DEVIATION 0.1 • n=5 Participants
CRST Tremor Motor Score	20.16 Score on a Scale STANDARD_DEVIATION 4.73 • n=5 Participants	19.6 Score on a Scale STANDARD_DEVIATION 4.51 • n=7 Participants	20.01 Score on a Scale STANDARD_DEVIATION 4.65 • n=5 Participants
Quality of Life for Essential Tremor (QUEST) Summary of Dimensions TOTAL Score	42.5 Average of 5 Dimension Percent Scores STANDARD_DEVIATION 18.3 • n=5 Participants	42.8 Average of 5 Dimension Percent Scores STANDARD_DEVIATION 19.5 • n=7 Participants	42.6 Average of 5 Dimension Percent Scores STANDARD_DEVIATION 18.5 • n=5 Participants
CRST Part C Functional Disabilities Score	16.5 Score on a Scale STANDARD_DEVIATION 4.64 • n=5 Participants	16.1 Score on a Scale STANDARD_DEVIATION 4.32 • n=7 Participants	16.4 Score on a Scale STANDARD_DEVIATION 4.53 • n=5 Participants

PRIMARY outcome

Timeframe: Baseline, 3 Months post-treatment

Outcome measures

Outcome measures
Measure	Transcranial ExAblate n=56 Participants Transcranial ExAblate Transcranial ExAblate	Sham Transcranial ExAblate n=20 Participants Sham Treatment with Transcranial ExAblate Sham Transcranial ExAblate	Crossover Transcranial Exablate After completing the 3 Month visit subjects randomized to the Sham group were presented with the opportunity to receive the Exablate treatment and continue in the study in the Crossover group. Nineteen subjects opted to continue in the Crossover group. Two subjects randomized to the Exablate test group received suboptimal treatment, were retreated, and followed in the Crossover group. Thus the total number of subjects in the initially in the Crossover group was 21.
Tremor Motor Score - Clinical Rating Scale for Tremor (CRST Part A (Upper Extremity) + Part B) Percent Change From Baseline	46.9 Percent Change from Baseline Interval 40.3 to 53.5	-0.1 Percent Change from Baseline Interval -9.6 to 9.5	—

PRIMARY outcome

Timeframe: 5 Years post treatment.

Population: Adverse Events and Serious Adverse Events are reported in the Adverse Events Section. Nineteen of the 21 subjects were Sham group subjects opting for treatment in the Crossover group. Two out of the 21 received subtherapeutic treatment in the Transcranial Exablate group and were retreated and followed in the Crossover group.

The cumulative sum of adverse events was followed through Year 5 of the study.

Outcome measures

Outcome measures
Measure	Transcranial ExAblate n=56 Participants Transcranial ExAblate Transcranial ExAblate	Sham Transcranial ExAblate n=20 Participants Sham Treatment with Transcranial ExAblate Sham Transcranial ExAblate	Crossover Transcranial Exablate n=21 Participants After completing the 3 Month visit subjects randomized to the Sham group were presented with the opportunity to receive the Exablate treatment and continue in the study in the Crossover group. Nineteen subjects opted to continue in the Crossover group. Two subjects randomized to the Exablate test group received suboptimal treatment, were retreated, and followed in the Crossover group. Thus the total number of subjects in the initially in the Crossover group was 21.
Number of Device and Procedure Related Adverse Events	184 Number of adverse events	26 Number of adverse events	75 Number of adverse events

SECONDARY outcome

Timeframe: Baseline, 3 Months, 6 Months, 12 Months, 2, 3, 4, 5 Years post treatment

Population: Subjects randomized to the Sham control group exited the study after completing the 3 month visit. They were given the opportunity to receive the Exablate treatment and complete the follow-up visit schedule. Nineteen Sham subjects opted to continue in the Crossover. Two subjects randomized to the Exablate group received suboptimal treatment, were retreated, and continued in the Crossover.

The percent change from baseline to Month 3 follow-up in upper extremity Tremor-Motor scores for the treated side is a sub-scale of Clinical Rating Scale for Tremor (CRST) Part A and Part B sum that was used to measure treated-side upper extremity tremor changes over time. Tremor-motor scores range from 0-32 points. Individual subject's scores at Baseline and Follow Up were used to calculate percent change from baseline and averaged across subjects. High percent change from baseline is better (shows improvement).

Outcome measures

Outcome measures
Measure	Transcranial ExAblate n=56 Participants Transcranial ExAblate Transcranial ExAblate	Sham Transcranial ExAblate n=20 Participants Sham Treatment with Transcranial ExAblate Sham Transcranial ExAblate	Crossover Transcranial Exablate n=21 Participants After completing the 3 Month visit subjects randomized to the Sham group were presented with the opportunity to receive the Exablate treatment and continue in the study in the Crossover group. Nineteen subjects opted to continue in the Crossover group. Two subjects randomized to the Exablate test group received suboptimal treatment, were retreated, and followed in the Crossover group. Thus the total number of subjects in the initially in the Crossover group was 21.
Tremor Motor Score - Clinical Rating Scale for Tremor (CRST) Part A (Upper Extremity) + Part B Percent Change From Baseline 3 Months	46.9 Percent Change from Baseline Interval 40.3 to 53.5	-0.1 Percent Change from Baseline Interval -9.6 to 9.5	53.1 Percent Change from Baseline Interval 43.4 to 62.8
Tremor Motor Score - Clinical Rating Scale for Tremor (CRST) Part A (Upper Extremity) + Part B Percent Change From Baseline 6 Months	43.1 Percent Change from Baseline Interval 36.4 to 49.9	—	50.7 Percent Change from Baseline Interval 41.8 to 59.6
Tremor Motor Score - Clinical Rating Scale for Tremor (CRST) Part A (Upper Extremity) + Part B Percent Change From Baseline 12 Months	39.6 Percent Change from Baseline Interval 34.0 to 45.3	—	47.0 Percent Change from Baseline Interval 30.6 to 63.3
Tremor Motor Score - Clinical Rating Scale for Tremor (CRST) Part A (Upper Extremity) + Part B Percent Change From Baseline 2 Years	55.9 Percent Change from Baseline Interval 48.9 to 63.0	—	56.2 Percent Change from Baseline Interval 40.5 to 71.8
Tremor Motor Score - Clinical Rating Scale for Tremor (CRST) Part A (Upper Extremity) + Part B Percent Change From Baseline 3 Years	52.6 Percent Change from Baseline Interval 45.5 to 59.6	—	53.5 Percent Change from Baseline Interval 39.3 to 67.7
Tremor Motor Score - Clinical Rating Scale for Tremor (CRST) Part A (Upper Extremity) + Part B Percent Change From Baseline 4 Years	46.8 Percent Change from Baseline Interval 37.7 to 55.8	—	55.5 Percent Change from Baseline Interval 41.7 to 56.7
Tremor Motor Score - Clinical Rating Scale for Tremor (CRST) Part A (Upper Extremity) + Part B Percent Change From Baseline 5 Years	37.5 Percent Change from Baseline Interval 26.3 to 48.8	—	50.2 Percent Change from Baseline Interval 32.5 to 67.9

SECONDARY outcome

Timeframe: Baseline, 3 Months, 6 Months, 12 Months, 2, 3, 4, 5 Years post treatment

The Posture Score is a sub-Score of the Clinical Rating Scale for Tremor CRST Part A - Posture (Treated Side Upper Extremity Posture Score). The scores range 0-12 and higher scores indicate worse outcomes. For percent improvement compared to Baseline (pre-treatment visit) higher percents mean better outcomes.

Outcome measures

Outcome measures
Measure	Transcranial ExAblate n=56 Participants Transcranial ExAblate Transcranial ExAblate	Sham Transcranial ExAblate n=20 Participants Sham Treatment with Transcranial ExAblate Sham Transcranial ExAblate	Crossover Transcranial Exablate n=21 Participants After completing the 3 Month visit subjects randomized to the Sham group were presented with the opportunity to receive the Exablate treatment and continue in the study in the Crossover group. Nineteen subjects opted to continue in the Crossover group. Two subjects randomized to the Exablate test group received suboptimal treatment, were retreated, and followed in the Crossover group. Thus the total number of subjects in the initially in the Crossover group was 21.
Clinical Rating Scale (CRST) Part A - Posture Score, Percent Change From Baseline (Pre-treatment) 3 Month	64.3 Percent Change from Baseline Interval 52.1 to 76.5	-4.4 Percent Change from Baseline Interval -27.0 to 18.2	56.4 Percent Change from Baseline Interval 36.6 to 76.1
Clinical Rating Scale (CRST) Part A - Posture Score, Percent Change From Baseline (Pre-treatment) 6 Month	62.5 Percent Change from Baseline Interval 50.8 to 74.2	—	56.8 Percent Change from Baseline Interval 36.3 to 77.2
Clinical Rating Scale (CRST) Part A - Posture Score, Percent Change From Baseline (Pre-treatment) 12 Month	65.5 Percent Change from Baseline Interval 54.7 to 76.3	—	46.4 Percent Change from Baseline Interval 22.3 to 70.4
Clinical Rating Scale (CRST) Part A - Posture Score, Percent Change From Baseline (Pre-treatment) 2 Year	73.8 Percent Change from Baseline Interval 65.2 to 82.4	—	78.7 Percent Change from Baseline Interval 68.5 to 88.8
Clinical Rating Scale (CRST) Part A - Posture Score, Percent Change From Baseline (Pre-treatment) 3 Year	76.8 Percent Change from Baseline Interval 67.5 to 86.0	—	76.1 Percent Change from Baseline Interval 61.6 to 90.6
Clinical Rating Scale (CRST) Part A - Posture Score, Percent Change From Baseline (Pre-treatment) 4 Year	72.0 Percent Change from Baseline Interval 59.8 to 84.2	—	71.4 Percent Change from Baseline Interval 56.4 to 86.4
Clinical Rating Scale (CRST) Part A - Posture Score, Percent Change From Baseline (Pre-treatment) 5 Year	72.0 Percent Change from Baseline Interval 60.49 to 85.5	—	75.7 Percent Change from Baseline Interval 57.8 to 93.6

SECONDARY outcome

Timeframe: Baseline, 3 Months, 6 Months, 12 Months, 2, 3, 4, 5 Years post treatment

1\. Subject daily functionalities: as measured by CRST Part-C (subscales) as percent change from Baseline. CRST Part-C is an 8-item score range 0-32. Higher percent change from Baseline means better outcomes.

Outcome measures

Outcome measures
Measure	Transcranial ExAblate n=56 Participants Transcranial ExAblate Transcranial ExAblate	Sham Transcranial ExAblate n=20 Participants Sham Treatment with Transcranial ExAblate Sham Transcranial ExAblate	Crossover Transcranial Exablate n=21 Participants After completing the 3 Month visit subjects randomized to the Sham group were presented with the opportunity to receive the Exablate treatment and continue in the study in the Crossover group. Nineteen subjects opted to continue in the Crossover group. Two subjects randomized to the Exablate test group received suboptimal treatment, were retreated, and followed in the Crossover group. Thus the total number of subjects in the initially in the Crossover group was 21.
Functional Disabilities - Clinical Rating Scale (CRST) for Tremor Part C Score Percent Change From Baseline 3 Months	63.8 Percent Change from Baseline Interval 55.3 to 72.4	1.8 Percent Change from Baseline Interval -6.7 to 11.1	74.6 Percent Change from Baseline Interval 66.2 to 82.9
Functional Disabilities - Clinical Rating Scale (CRST) for Tremor Part C Score Percent Change From Baseline 6 Months	61.8 Percent Change from Baseline Interval 53.2 to 70.4	—	72.1 Percent Change from Baseline Interval 62.4 to 81.8
Functional Disabilities - Clinical Rating Scale (CRST) for Tremor Part C Score Percent Change From Baseline 12 Months	64.0 Percent Change from Baseline Interval 55.2 to 72.7	—	68.9 Percent Change from Baseline Interval 55.0 to 82.9
Functional Disabilities - Clinical Rating Scale (CRST) for Tremor Part C Score Percent Change From Baseline 2 Years	62.1 Percent Change from Baseline Interval 53.6 to 70.6	—	61.9 Percent Change from Baseline Interval 47.4 to 76.3
Functional Disabilities - Clinical Rating Scale (CRST) for Tremor Part C Score Percent Change From Baseline 3 Years	58.7 Percent Change from Baseline Interval 50.1 to 67.3	—	51.0 Percent Change from Baseline Interval 31.5 to 70.6
Functional Disabilities - Clinical Rating Scale (CRST) for Tremor Part C Score Percent Change From Baseline 4 Years	47.8 Percent Change from Baseline Interval 35.1 to 59.9	—	49.5 Percent Change from Baseline Interval 27.6 to 71.4
Functional Disabilities - Clinical Rating Scale (CRST) for Tremor Part C Score Percent Change From Baseline 5 Years	43.4 Percent Change from Baseline Interval 30.8 to 56.0	—	51.4 Percent Change from Baseline Interval 28.7 to 74.0

SECONDARY outcome

Timeframe: Baseline, 3 Months, 6 Months, 12 Months, 2, 3, 4, 5 Years post treatment

The percent change from baseline to follow-up QUEST Summary Total was used to assess quality of life changes over time in tremor patients. The QUEST consists of five dimensions for each subject converted to a percent of the total (0-100%). The summary total is the average of the five dimensions. High percent change from baseline is better (shows improvement).

Outcome measures

Outcome measures
Measure	Transcranial ExAblate n=56 Participants Transcranial ExAblate Transcranial ExAblate	Sham Transcranial ExAblate n=20 Participants Sham Treatment with Transcranial ExAblate Sham Transcranial ExAblate	Crossover Transcranial Exablate n=21 Participants After completing the 3 Month visit subjects randomized to the Sham group were presented with the opportunity to receive the Exablate treatment and continue in the study in the Crossover group. Nineteen subjects opted to continue in the Crossover group. Two subjects randomized to the Exablate test group received suboptimal treatment, were retreated, and followed in the Crossover group. Thus the total number of subjects in the initially in the Crossover group was 21.
Quality of Life in Essential Tremor Questionnaire (QUEST) Summary Total Percent Change From Baseline 3 Months	43.2 Percent Change from Baseline Interval 34.3 to 56.3	5.0 Percent Change from Baseline Interval -14.9 to 36.2	59.2 Percent Change from Baseline Interval 43.8 to 74.7
Quality of Life in Essential Tremor Questionnaire (QUEST) Summary Total Percent Change From Baseline 6 Months	41.1 Percent Change from Baseline Interval 28.8 to 53.4	—	58.4 Percent Change from Baseline Interval 42.5 to 74.3
Quality of Life in Essential Tremor Questionnaire (QUEST) Summary Total Percent Change From Baseline 12 Months	47.1 Percent Change from Baseline Interval 34.8 to 59.5	—	61.5 Percent Change from Baseline Interval 46.0 to 77.1
Quality of Life in Essential Tremor Questionnaire (QUEST) Summary Total Percent Change From Baseline 2 Years	48.5 Percent Change from Baseline Interval 37.4 to 59.7	—	49.2 Percent Change from Baseline Interval 31.0 to 59.7
Quality of Life in Essential Tremor Questionnaire (QUEST) Summary Total Percent Change From Baseline 3 Years	41.0 Percent Change from Baseline Interval 25.6 to 56.3	—	24.3 Percent Change from Baseline Interval -19.1 to 67.6
Quality of Life in Essential Tremor Questionnaire (QUEST) Summary Total Percent Change From Baseline 4 Years	36.9 Percent Change from Baseline Interval 24.9 to 48.8	—	21.7 Percent Change from Baseline Interval -24.9 to 68.3
Quality of Life in Essential Tremor Questionnaire (QUEST) Summary Total Percent Change From Baseline 5 Years	31.2 Percent Change from Baseline Interval 17.9 to 44.6	—	16.6 Percent Change from Baseline Interval -34.2 to 67.3

Adverse Events

Transcranial ExAblate

Serious events: 6 serious events

Other events: 49 other events

Deaths: 0 deaths

Sham Transcranial ExAblate

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Crossover Transcranial Exablate

Serious events: 0 serious events

Other events: 19 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Transcranial ExAblate n=56 participants at risk Transcranial ExAblate Transcranial ExAblate	Sham Transcranial ExAblate n=20 participants at risk Sham Treatment with Transcranial ExAblate Sham Transcranial ExAblate	Crossover Transcranial Exablate n=21 participants at risk After completing the 3 Month visit subjects randomized to the Sham group were presented with the opportunity to receive the Exablate treatment and continue in the study in the Crossover group. Nineteen subjects opted to continue in the Crossover group. Two subjects randomized to the Exablate test group received suboptimal treatment, were retreated, and followed in the Crossover group. Thus the total number of subjects in the initially in the Crossover group was 21.
Nervous system disorders Embolic Stroke	1.8% 1/56 • Number of events 1 • Intraoperative through 5 Years. Adverse events were assessed at 3 months, 6 months, 12 months and annually for years 2 through 5. For the Exablate and Crossover Groups Adverse Events were assessed at each follow-up study visit through the 5 Year post treatment follow-up. For the Sham Group Adverse were assessed and reported through the 3 Months post treatment follow-up.	0.00% 0/20 • Intraoperative through 5 Years. Adverse events were assessed at 3 months, 6 months, 12 months and annually for years 2 through 5. For the Exablate and Crossover Groups Adverse Events were assessed at each follow-up study visit through the 5 Year post treatment follow-up. For the Sham Group Adverse were assessed and reported through the 3 Months post treatment follow-up.	0.00% 0/21 • Intraoperative through 5 Years. Adverse events were assessed at 3 months, 6 months, 12 months and annually for years 2 through 5. For the Exablate and Crossover Groups Adverse Events were assessed at each follow-up study visit through the 5 Year post treatment follow-up. For the Sham Group Adverse were assessed and reported through the 3 Months post treatment follow-up.
Nervous system disorders Numbness and Tingling	1.8% 1/56 • Number of events 1 • Intraoperative through 5 Years. Adverse events were assessed at 3 months, 6 months, 12 months and annually for years 2 through 5. For the Exablate and Crossover Groups Adverse Events were assessed at each follow-up study visit through the 5 Year post treatment follow-up. For the Sham Group Adverse were assessed and reported through the 3 Months post treatment follow-up.	0.00% 0/20 • Intraoperative through 5 Years. Adverse events were assessed at 3 months, 6 months, 12 months and annually for years 2 through 5. For the Exablate and Crossover Groups Adverse Events were assessed at each follow-up study visit through the 5 Year post treatment follow-up. For the Sham Group Adverse were assessed and reported through the 3 Months post treatment follow-up.	0.00% 0/21 • Intraoperative through 5 Years. Adverse events were assessed at 3 months, 6 months, 12 months and annually for years 2 through 5. For the Exablate and Crossover Groups Adverse Events were assessed at each follow-up study visit through the 5 Year post treatment follow-up. For the Sham Group Adverse were assessed and reported through the 3 Months post treatment follow-up.
Cardiac disorders Atrial fibrillation	1.8% 1/56 • Number of events 1 • Intraoperative through 5 Years. Adverse events were assessed at 3 months, 6 months, 12 months and annually for years 2 through 5. For the Exablate and Crossover Groups Adverse Events were assessed at each follow-up study visit through the 5 Year post treatment follow-up. For the Sham Group Adverse were assessed and reported through the 3 Months post treatment follow-up.	0.00% 0/20 • Intraoperative through 5 Years. Adverse events were assessed at 3 months, 6 months, 12 months and annually for years 2 through 5. For the Exablate and Crossover Groups Adverse Events were assessed at each follow-up study visit through the 5 Year post treatment follow-up. For the Sham Group Adverse were assessed and reported through the 3 Months post treatment follow-up.	0.00% 0/21 • Intraoperative through 5 Years. Adverse events were assessed at 3 months, 6 months, 12 months and annually for years 2 through 5. For the Exablate and Crossover Groups Adverse Events were assessed at each follow-up study visit through the 5 Year post treatment follow-up. For the Sham Group Adverse were assessed and reported through the 3 Months post treatment follow-up.
Ear and labyrinth disorders Syncopal episode	1.8% 1/56 • Number of events 1 • Intraoperative through 5 Years. Adverse events were assessed at 3 months, 6 months, 12 months and annually for years 2 through 5. For the Exablate and Crossover Groups Adverse Events were assessed at each follow-up study visit through the 5 Year post treatment follow-up. For the Sham Group Adverse were assessed and reported through the 3 Months post treatment follow-up.	0.00% 0/20 • Intraoperative through 5 Years. Adverse events were assessed at 3 months, 6 months, 12 months and annually for years 2 through 5. For the Exablate and Crossover Groups Adverse Events were assessed at each follow-up study visit through the 5 Year post treatment follow-up. For the Sham Group Adverse were assessed and reported through the 3 Months post treatment follow-up.	0.00% 0/21 • Intraoperative through 5 Years. Adverse events were assessed at 3 months, 6 months, 12 months and annually for years 2 through 5. For the Exablate and Crossover Groups Adverse Events were assessed at each follow-up study visit through the 5 Year post treatment follow-up. For the Sham Group Adverse were assessed and reported through the 3 Months post treatment follow-up.
Reproductive system and breast disorders Breast cancer	1.8% 1/56 • Number of events 1 • Intraoperative through 5 Years. Adverse events were assessed at 3 months, 6 months, 12 months and annually for years 2 through 5. For the Exablate and Crossover Groups Adverse Events were assessed at each follow-up study visit through the 5 Year post treatment follow-up. For the Sham Group Adverse were assessed and reported through the 3 Months post treatment follow-up.	0.00% 0/20 • Intraoperative through 5 Years. Adverse events were assessed at 3 months, 6 months, 12 months and annually for years 2 through 5. For the Exablate and Crossover Groups Adverse Events were assessed at each follow-up study visit through the 5 Year post treatment follow-up. For the Sham Group Adverse were assessed and reported through the 3 Months post treatment follow-up.	0.00% 0/21 • Intraoperative through 5 Years. Adverse events were assessed at 3 months, 6 months, 12 months and annually for years 2 through 5. For the Exablate and Crossover Groups Adverse Events were assessed at each follow-up study visit through the 5 Year post treatment follow-up. For the Sham Group Adverse were assessed and reported through the 3 Months post treatment follow-up.
Vascular disorders TIA	3.6% 2/56 • Number of events 2 • Intraoperative through 5 Years. Adverse events were assessed at 3 months, 6 months, 12 months and annually for years 2 through 5. For the Exablate and Crossover Groups Adverse Events were assessed at each follow-up study visit through the 5 Year post treatment follow-up. For the Sham Group Adverse were assessed and reported through the 3 Months post treatment follow-up.	0.00% 0/20 • Intraoperative through 5 Years. Adverse events were assessed at 3 months, 6 months, 12 months and annually for years 2 through 5. For the Exablate and Crossover Groups Adverse Events were assessed at each follow-up study visit through the 5 Year post treatment follow-up. For the Sham Group Adverse were assessed and reported through the 3 Months post treatment follow-up.	0.00% 0/21 • Intraoperative through 5 Years. Adverse events were assessed at 3 months, 6 months, 12 months and annually for years 2 through 5. For the Exablate and Crossover Groups Adverse Events were assessed at each follow-up study visit through the 5 Year post treatment follow-up. For the Sham Group Adverse were assessed and reported through the 3 Months post treatment follow-up.

Other adverse events

Additional Information

Nadir Alikacem, SVP Global Regulated Clinical Affairs

Insightec

Phone: 214-360-9900

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place