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The objective of this prospective, randomized, double-blind (to subjects, local site's blinded assessor and Tremor Core Lab assessors), crossover, multi-site, two-arm study (ExAblate treated arm Vs ExAblate Sham treated control arm) is to test the efficacy of treatment using the ExAblate Transcranial System and to further demonstrate safety in medication-refractory tremor in subjects with essential tremor (ET).
This study is evaluating a new technique for performing Thalamotomy for tremor control. While current techniques have possible invasive or radiation effects, the use of ExAblate if totally non-invasive and without any radiation. After informed consent and screening, eligible subjects will be randomized to either an ExAblate treatment or an ExAblate Sham or "fake" procedure. The chance of randomization to Sham is one out of four. Subjects who are randomized to Sham Control will undergo the same procedure and follow-up visits through their Month 3 visit. After the Month 3 assessments are complete, all subjects will be unblinded and those in the Sham treated group will have the option for an actual ExAblate treatment in an unblinded fashion, as long as they still qualify for ExAblate treatment. All subjects will be followed at 6 and 12 months and for up to 5 years as directed by their doctor.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Transcranial ExAblate | Experimental | Transcranial ExAblate |
|
| Sham Transcranial ExAblate | Sham Comparator | Sham Treatment with Transcranial ExAblate |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcranial ExAblate | Device |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Tremor Motor Score - Clinical Rating Scale for Tremor (CRST Part A (Upper Extremity) + Part B) Percent Change From Baseline | 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). | Baseline, 3 Months post-treatment |
| Number of Device and Procedure Related Adverse Events | The cumulative sum of adverse events was followed through Year 5 of the study. | 5 Years post treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| Tremor Motor Score - Clinical Rating Scale for Tremor (CRST) Part A (Upper Extremity) + Part B Percent Change From Baseline | 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University Medical Center | Stanford | California | 94305 | United States | ||
| University of Maryland Medical System |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35995551 | Derived | Yamamoto K, Sarica C, Elias GJB, Boutet A, Germann J, Loh A, Joel SE, Bigioni L, Gwun D, Gramer R, Li SX, Zemmar A, Vetkas A, Algarni M, Devenyi G, Chakravarty M, Hynynen K, Scantlebury N, Schwartz ML, Lozano AM, Fasano A. Ipsilateral and axial tremor response to focused ultrasound thalamotomy for essential tremor: clinical outcomes and probabilistic mapping. J Neurol Neurosurg Psychiatry. 2022 Aug 22:jnnp-2021-328459. doi: 10.1136/jnnp-2021-328459. Online ahead of print. | |
| 35932269 |
Not provided
| ID | Type | URL | Comment |
|---|---|---|---|
| Clinical Study Report | View IPD |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| FG002 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Main Study |
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| Main Continuation / Crossover Phase |
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| Long-term Annual Follow-up |
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| ID | Title | Description |
|---|---|---|
| BG000 | Transcranial ExAblate | Transcranial ExAblate Transcranial ExAblate |
| BG001 | Sham Transcranial ExAblate | Sham Treatment with Transcranial ExAblate Sham Transcranial ExAblate |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Tremor Motor Score - Clinical Rating Scale for Tremor (CRST Part A (Upper Extremity) + Part B) Percent Change From Baseline | 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). | Posted | Mean | 95% Confidence Interval | Percent Change from Baseline | Baseline, 3 Months post-treatment |
|
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Transcranial ExAblate | Transcranial ExAblate Transcranial ExAblate | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Embolic Stroke | Nervous system disorders | Custom | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bradycardia | Cardiac disorders | Custom | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Nadir Alikacem, SVP Global Regulated Clinical Affairs | Insightec | 214-360-9900 | nadira@insightec.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 13, 2017 | Oct 4, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 10, 2014 | Oct 4, 2023 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D020329 | Essential Tremor |
| ID | Term |
|---|---|
| D009069 | Movement Disorders |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| Sham Transcranial ExAblate | Device |
|
| Baseline, 3 Months, 6 Months, 12 Months, 2, 3, 4, 5 Years post treatment |
| Clinical Rating Scale (CRST) Part A - Posture Score, Percent Change From Baseline (Pre-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. | Baseline, 3 Months, 6 Months, 12 Months, 2, 3, 4, 5 Years post treatment |
| Functional Disabilities - Clinical Rating Scale (CRST) for Tremor Part C Score Percent Change From Baseline | 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. | Baseline, 3 Months, 6 Months, 12 Months, 2, 3, 4, 5 Years post treatment |
| Quality of Life in Essential Tremor Questionnaire (QUEST) Summary Total Percent Change From Baseline | 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). | Baseline, 3 Months, 6 Months, 12 Months, 2, 3, 4, 5 Years post treatment |
| Baltimore |
| Maryland |
| 21201 |
| United States |
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | United States |
| University of Virginia | Charlottesville | Virginia | 22908 | United States |
| Swedish Medical Center | Seattle | Washington | 98122 | United States |
| Sunnybrook Health Sciences Centre | Toronto | Ontario | M4N 3M5 | Canada |
| Tokyo Women's Medical University (TWMU) | Tokyo | 162-8666 | Japan |
| Yonsei University Medical Center | Seoul | 120-752 | South Korea |
| Derived |
| Cosgrove GR, Lipsman N, Lozano AM, Chang JW, Halpern C, Ghanouni P, Eisenberg H, Fishman P, Taira T, Schwartz ML, McDannold N, Hayes M, Ro S, Shah B, Gwinn R, Santini VE, Hynynen K, Elias WJ. Magnetic resonance imaging-guided focused ultrasound thalamotomy for essential tremor: 5-year follow-up results. J Neurosurg. 2022 Aug 5;138(4):1028-1033. doi: 10.3171/2022.6.JNS212483. Print 2023 Apr 1. |
| 31748250 | Derived | Halpern CH, Santini V, Lipsman N, Lozano AM, Schwartz ML, Shah BB, Elias WJ, Cosgrove GR, Hayes MT, McDannold N, Aldrich C, Eisenberg HM, Gandhi D, Taira T, Gwinn R, Ro S, Witt J, Jung NY, Chang JW, Rosenberg J, Ghanouni P. Three-year follow-up of prospective trial of focused ultrasound thalamotomy for essential tremor. Neurology. 2019 Dec 10;93(24):e2284-e2293. doi: 10.1212/WNL.0000000000008561. Epub 2019 Nov 20. |
| 27557301 | Derived | Elias WJ, Lipsman N, Ondo WG, Ghanouni P, Kim YG, Lee W, Schwartz M, Hynynen K, Lozano AM, Shah BB, Huss D, Dallapiazza RF, Gwinn R, Witt J, Ro S, Eisenberg HM, Fishman PS, Gandhi D, Halpern CH, Chuang R, Butts Pauly K, Tierney TS, Hayes MT, Cosgrove GR, Yamaguchi T, Abe K, Taira T, Chang JW. A Randomized Trial of Focused Ultrasound Thalamotomy for Essential Tremor. N Engl J Med. 2016 Aug 25;375(8):730-9. doi: 10.1056/NEJMoa1600159. |
| COMPLETED |
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| NOT COMPLETED |
|
|
| COMPLETED |
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| NOT COMPLETED |
|
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Skull Density Ratio | Mean | Standard Deviation | Ratio |
|
| CRST Tremor Motor Score | Baseline sum of upper extremity Tremor-Motor scores for the treated side from the Clinical Rating Scale for Tremor (CRST) Part A and Part B averaged across subjects. This measure of upper extremity tremor ranges from 0-32 with high scores being worse. The individual baseline scores were divided by the total score possible depending on handedness. Lower scores are better than higher scores. | Mean | Standard Deviation | Score on a Scale |
|
| Quality of Life for Essential Tremor (QUEST) Summary of Dimensions TOTAL Score | Baseline Quality of Life for Essential Tremor (QUEST) TOTAL is the mean of five QUEST dimensions each as a percent of the total possible. The QUEST is a 30-item assessment with each item scored 0-4 (total min - max is 0 - 120). For each subject, each of the 5 QUEST dimension scores is a percentage (100%-0%) of total possible for each dimension. The QUEST summary of dimensions total is a mean of the five dimension scores. Lower QUEST scores are better than higher scores. | Mean | Standard Deviation | Average of 5 Dimension Percent Scores |
|
| CRST Part C Functional Disabilities Score | Baseline Clinical Rating Scale for Tremor (CRST) Part C is a measure of functional disability due to tremor. The Clinical Rating Scale for Tremor Part C consists of 8 items each scored from 0 to 4. Thus, the total score summed ranges from 0 to 32 (average, 0-4) and provides an overall assessment of activities of daily living. Low scores on the Clinical Rating Scale for Tremor (CRST) Part C are better. Low scores show improvement in functional disabilities compared to higher scores. | Mean | Standard Deviation | Score on a Scale |
|
| Sham Transcranial ExAblate |
Sham Treatment with Transcranial ExAblate Sham Transcranial ExAblate |
|
|
|
| Primary | Number of Device and Procedure Related Adverse Events | The cumulative sum of adverse events was followed through Year 5 of the study. | 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. | Posted | Number | Number of adverse events | 5 Years post treatment. |
|
|
|
| Secondary | Tremor Motor Score - Clinical Rating Scale for Tremor (CRST) Part A (Upper Extremity) + Part B Percent Change From Baseline | 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). | 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. | Posted | Mean | 95% Confidence Interval | Percent Change from Baseline | Baseline, 3 Months, 6 Months, 12 Months, 2, 3, 4, 5 Years post treatment |
|
|
|
| Secondary | Clinical Rating Scale (CRST) Part A - Posture Score, Percent Change From Baseline (Pre-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. | 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. | Posted | Mean | 95% Confidence Interval | Percent Change from Baseline | Baseline, 3 Months, 6 Months, 12 Months, 2, 3, 4, 5 Years post treatment |
|
|
|
| Secondary | Functional Disabilities - Clinical Rating Scale (CRST) for Tremor Part C Score Percent Change From Baseline | 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. | 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. | Posted | Mean | 95% Confidence Interval | Percent Change from Baseline | Baseline, 3 Months, 6 Months, 12 Months, 2, 3, 4, 5 Years post treatment |
|
|
|
| Secondary | Quality of Life in Essential Tremor Questionnaire (QUEST) Summary Total Percent Change From Baseline | 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). | 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. | Posted | Mean | 95% Confidence Interval | Percent Change from Baseline | Baseline, 3 Months, 6 Months, 12 Months, 2, 3, 4, 5 Years post treatment |
|
|
|
| 56 |
| 6 |
| 56 |
| 49 |
| 56 |
| EG001 | Sham Transcranial ExAblate | Sham Treatment with Transcranial ExAblate Sham Transcranial ExAblate | 0 | 20 | 0 | 20 | 6 | 20 |
| EG002 | 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. | 0 | 21 | 0 | 21 | 19 | 21 |
| Numbness and Tingling | Nervous system disorders | Custom | Systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | Custom | Systematic Assessment |
|
| Syncopal episode | Ear and labyrinth disorders | Custom | Systematic Assessment |
|
| Breast cancer | Reproductive system and breast disorders | Custom | Systematic Assessment |
|
| TIA | Vascular disorders | Custom | Systematic Assessment |
|
| Hypertentsion | Vascular disorders | Custom | Systematic Assessment |
|
| Hypotension | Vascular disorders | Custom | Systematic Assessment |
|
| TIA | Vascular disorders | Custom | Systematic Assessment |
|
| Tinnitus | Ear and labyrinth disorders | Custom | Systematic Assessment |
|
| Preventricular contractions | Cardiac disorders | Custom | Systematic Assessment |
|
| Sick sinus syndrome | Cardiac disorders | Custom | Systematic Assessment |
|
| Vision problems | Eye disorders | Custom | Systematic Assessment |
|
| Watering eyes | Eye disorders | Custom | Systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | Custom | Systematic Assessment |
|
| Dysgeusia | Gastrointestinal disorders | Custom | Systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | Custom | Systematic Assessment |
|
| Nausea/Vomiting | Gastrointestinal disorders | Custom | Systematic Assessment |
|
| Increased salivation | Gastrointestinal disorders | Custom | Systematic Assessment |
|
| Fatigue | General disorders | Custom | Systematic Assessment |
|
| Weakness | General disorders | Custom | Systematic Assessment |
|
| Impatience | General disorders | Custom | Systematic Assessment |
|
| Restlessness | General disorders | Custom | Systematic Assessment |
|
| Common cold | Infections and infestations | Custom | Systematic Assessment |
|
| Flu | Infections and infestations | Custom | Systematic Assessment |
|
| Ear infection | Infections and infestations | Custom | Systematic Assessment |
|
| Dysergia | Musculoskeletal and connective tissue disorders | Custom | Systematic Assessment |
|
| Dysmetria | Musculoskeletal and connective tissue disorders | Custom | Systematic Assessment |
|
| Gait disturbance | Musculoskeletal and connective tissue disorders | Custom | Systematic Assessment |
|
| Imbalance | Musculoskeletal and connective tissue disorders | Custom | Systematic Assessment |
|
| Musculoskeletal weakness | Musculoskeletal and connective tissue disorders | Custom | Systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | Custom | Systematic Assessment |
|
| Positional pain | Musculoskeletal and connective tissue disorders | Custom | Systematic Assessment |
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| Unsteady | Musculoskeletal and connective tissue disorders | Custom | Systematic Assessment |
|
| Anxiety | Nervous system disorders | Custom | Systematic Assessment |
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| Ataxia | Nervous system disorders | Custom | Systematic Assessment |
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| Cognitive disturbance | Nervous system disorders | Custom | Systematic Assessment |
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| Dizziness | Nervous system disorders | Custom | Systematic Assessment |
|
| Dysarthria | Nervous system disorders | Custom | Systematic Assessment |
|
| Dysesthesia | Nervous system disorders | Custom | Systematic Assessment |
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| Dysgeusia | Nervous system disorders | Custom | Systematic Assessment |
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| Dysgnosia | Nervous system disorders | Custom | Systematic Assessment |
|
| Dysmetria | Nervous system disorders | Custom | Systematic Assessment |
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| Dysmnesia | Nervous system disorders | Custom | Systematic Assessment |
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| Grogginess | Nervous system disorders | Custom | Systematic Assessment |
|
| Hand tremor (untreated side) | Nervous system disorders | Custom | Systematic Assessment |
|
| Involuntary movements-UE | Nervous system disorders | Custom | Systematic Assessment |
|
| Memory deterioration | Nervous system disorders | Custom | Systematic Assessment |
|
| Numbness/Tingling | Nervous system disorders | Custom | Systematic Assessment |
|
| Paresthesia | Nervous system disorders | Custom | Systematic Assessment |
|
| Slow movements | Nervous system disorders | Custom | Systematic Assessment |
|
| Slurred speech | Nervous system disorders | Custom | Systematic Assessment |
|
| Somnolence | Nervous system disorders | Custom | Systematic Assessment |
|
| Ankle pain | General disorders | Custom | Systematic Assessment |
|
| Foot pain | General disorders | Custom | Systematic Assessment |
|
| Headache | General disorders | Custom | Systematic Assessment |
|
| Sonication-related head pain | General disorders | Custom | Systematic Assessment |
|
| Ptosis | Product Issues | Custom | Systematic Assessment | Stereotactic frame / Pin site related |
|
| Facial edema | Product Issues | Custom | Systematic Assessment | Stereotactic frame / pin site related |
|
| Numbness / Tingling | Product Issues | Custom | Systematic Assessment | Stereotactic frame / pin site related |
|
| Pin site bleeding | Product Issues | Custom | Systematic Assessment | Stereotactic frame related |
|
| Pin site edema | Product Issues | Custom | Systematic Assessment | Stereotactic frame related |
|
| Pin site pain | Product Issues | Custom | Systematic Assessment | Stereotactic frame related |
|
| Pin site abrasion | Product Issues | Custom | Systematic Assessment | Stereotactic frame related |
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| Bruising | Product Issues | Custom | Systematic Assessment | Stereotactic frame related |
|
| Catheter irritation | Renal and urinary disorders | Custom | Systematic Assessment |
|
| Urinary urgency | Renal and urinary disorders | Custom | Systematic Assessment |
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| BPH | Renal and urinary disorders | Custom | Systematic Assessment |
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| Vertigo | Ear and labyrinth disorders | Custom | Systematic Assessment |
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| Dizziness | Ear and labyrinth disorders | Custom | Systematic Assessment |
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| Paroxysmal vertigo issues | Ear and labyrinth disorders | Custom | Systematic Assessment |
|
| Hiccups | General disorders | Custom | Systematic Assessment |
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| Skin rash | Skin and subcutaneous tissue disorders | Custom | Systematic Assessment |
|
Not provided
Not provided
| 6 Months |
|
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| 12 Months |
|
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| 2 Years |
|
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| 3 Years |
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| 4 Years |
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| 5 Years |
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| 6 Month |
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| 12 Month |
|
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| 2 Year |
|
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| 3 Year |
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| 4 Year |
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| 5 Year |
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| 6 Months |
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| 12 Months |
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| 2 Years |
|
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| 3 Years |
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| 4 Years |
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| 5 Years |
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| 6 Months |
|
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| 12 Months |
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| 2 Years |
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| 3 Years |
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| 4 Years |
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| 5 Years |
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