Essential TremorATAXNCT03769961
Ataxia in Essential Tremor: Describing the Differences Between Disease Process and Treatment Effect
An observational study of Essential Tremor and Deep Brain Stimulation, run by Oregon Health and Science University at 2 sites in United States.
Trial summary
The proposed study aims to characterize ataxia occurring in essential tremor and essential tremor with DBS. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Essential Tremor, Deep Brain Stimulation, Ataxia
- How many people
- 6 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Dec 2018to 14 Sep 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Essential Tremor participants with and without ataxia
Who may be able to join
- Essential Tremor diagnosis at least 3 years duration
- Absence of other neurological signes (such as dystonia, ataxia, or Parkinsonism)
- Patients must be able to walk 2 minutes unassisted.
- Patients must be able to understand and consent to be in the study.
Who cannot join
- Patients who have had changes in DBS settings within the last 3 months.
- Patients who have had no initial improvement or response to DBS.
- ET medication changes in the last month.
- Actively abusing alcohol.
- A neurologic diagnosis other than ET that in the investigator's opinion could affect gait and/or balance.
- Atypical tremor disorder including by not limited to tremor due to multiple sclerosis, medication-induced tremor, Parkinson's disease, or parkinsonian syndrome.
- Dementia
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Oregon Health & Science University
Portland, Oregon, 97201
VA Portland Health Care System
Portland, Oregon, 97239
About this study
Official title: Ataxia in Essential Tremor: Describing the Differences Between Disease Process and Treatment Effect (ATAX)
The proposed study aims to characterize ataxia occurring in essential tremor and essential tremor with DBS.
Read the detailed description
Objectives: In recent years, there has been a growing amount of evidence tying Essential Tremor (ET) to cerebellar dysfunction. This has been clinically observed, demonstrated through specific gait measures of ataxia (often involving tandem gait), and confirmed through Positron emission tomography (PET) imaging. Deep Brain stimulation for ET has become a widely utilized therapeutic intervention for patients, and the bilateral thalamic ventralis intermedius (VIM) is most commonly implanted. However, it has been noted that in some patients gait ataxia significantly worsens post-op. This initially was thought to be a result of disease progression, but recent studies have in fact shown that this is a DBS related phenomenon.
Methods: Participants will have two visits to either the Portland VA or Oregon Health \& Science University (OHSU). At each visit, several assessments of balance, tremor, gait and balance, and DBS settings will be made. The gait and balance assessments will be performed by a unblinded and a blinded rater.
- Conditions
- Essential Tremor, Deep Brain Stimulation, Ataxia, Cerebellar Diseases
- Being tested
- No intervention
- Keywords
- essential tremor, dbs
- Medical subject headings
- Essential Tremor, Ataxia, Cerebellar Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No interventions - Observational study
| Study group | Role | What they receive |
|---|---|---|
| ET (DBS-, Ataxia+) | Essential Tremor without DBS with Ataxia on examination Receives: Other: No intervention | |
| ET (DBS-, Ataxia-) | Essential Tremor without DBS and without Ataxia on examination Receives: Other: No intervention | |
| ET (DBS+, Ataxia+) | Essential Tremor with DBS with Ataxia on examination Receives: Other: No intervention | |
| ET (DBS+, Ataxia-) | Essential Tremor with DBS without Ataxia Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ataxia Differences between DBS and no DBS
Compare the Scale of the Assessment and Rating of Ataxia (SARA) total score between DBS and no DBS participants with essential tremor. This 8-item scale rates gait (0-8 points), stance (0-6 points), sitting (0-4 points), speech disturbance (0-6 points), finger chase (0-4 points), nose-finger test (0-4 points), fast alternating hand movements (0-4 points), and heel-shin slide (0-4 points). Motor activists of the four extremities (items 5-8) assessments are performed bilaterally, mean values to obtain a total score. Cumulative score ranges from 0 (no ataxia) to 40 (most severe ataxia).
Measured: Visit 2 (after DBS has been turned off for 3-10 days)
Secondary outcomes (1)
Balance Confidence
The Activities-Specific Balance Confidence Scale (ABC) is a subjective measure of confidence in performing various ambulatory activities without falling or experiencing a sense of unsteadiness. The ABC scale is a 16-item self-report measure in which participants rate their balance confidence on a 0-100 scale (0 = 0 no confidence, 100 = 100 complete confidence). Overall score is calculated by adding item scores and dividing by the total number of items.
Measured: Visit 2 (after DBS has been turned off for 3-10 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2018
- Study start1 Dec 2018
- Primary completion14 Sep 2020
- Study completion14 Sep 2020
Why it stopped: Low enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Essential TremorStudies of the same condition, open and under way.
- More trials run by Oregon Health and Science UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Collaborators
- Portland VA Medical Center
- Responsible party
- Principal investigator, Amie Hiller, MD, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03769961
- Sponsor's protocol ID
- 18608
- Acronym
- ATAX
- Status last verified
- Sep 2020
- First submitted
- 6 Dec 2018
- Last updated
- 17 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Post data entry and verification, data and specimens will be de-identified (no 18 HIPAA identifiers and age aggregated for those \> 89 years old) and transferred to the Neurological Disorder Repository (MIRB # 3129). This repository is maintained at the Portland VA Health Care System. Verification of the coded data set creation and the absence of the identifiers will be created and retained in the study files. The research coordinator will be responsible for the creation and verification process. The key to the code will be maintained by the study and will not be released to the repository. The recipient investigator must present the data use agreement, documentation of an Institutional Review Boar (IRB) approved protocol and Informed Conset Form (ICF) allowing the release of the identifiable specimens/data, or the release of coded specimens/data.
Publications
Ramirez-Zamora A, Boggs H, Pilitsis JG. Reduction in DBS frequency improves balance difficulties after thalamic DBS for essential tremor. J Neurol Sci. 2016 Aug 15;367:122-7. doi: 10.1016/j.jns.2016.06.001. Epub 2016 Jun 2.
PubMed 27423573Nazzaro JM, Lyons KE, Pahwa R. Deep brain stimulation for essential tremor. Handb Clin Neurol. 2013;116:155-66. doi: 10.1016/B978-0-444-53497-2.00013-9.
PubMed 24112892Kronenbuerger M, Konczak J, Ziegler W, Buderath P, Frank B, Coenen VA, Kiening K, Reinacher P, Noth J, Timmann D. Balance and motor speech impairment in essential tremor. Cerebellum. 2009 Sep;8(3):389-98. doi: 10.1007/s12311-009-0111-y. Epub 2009 May 19.
PubMed 19452239Fasano A, Herzog J, Raethjen J, Rose FE, Muthuraman M, Volkmann J, Falk D, Elble R, Deuschl G. Gait ataxia in essential tremor is differentially modulated by thalamic stimulation. Brain. 2010 Dec;133(Pt 12):3635-48. doi: 10.1093/brain/awq267. Epub 2010 Oct 5.
PubMed 20926368
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ataxia in Essential Tremor: Describing the Differences Between Disease Process and Treatment Effect (ATAX)
- ClinicalTrials.gov ID
- NCT03769961
- Acronym / sponsor ID
- ATAX / 18608
- Conditions
- Essential Tremor, Deep Brain Stimulation, Ataxia, Cerebellar Diseases
- Keywords
- essential tremor, dbs
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Low enrollment
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Collaborators
- Portland VA Medical Center
- Study start
- 1 Dec 2018 (actual)
- Primary completion
- 14 Sep 2020 (actual)
- Study completion
- 14 Sep 2020 (actual)
- First posted
- 10 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The proposed study aims to characterize ataxia occurring in essential tremor and essential tremor with DBS.
Detailed description
Objectives: In recent years, there has been a growing amount of evidence tying Essential Tremor (ET) to cerebellar dysfunction. This has been clinically observed, demonstrated through specific gait measures of ataxia (often involving tandem gait), and confirmed through Positron emission tomography (PET) imaging. Deep Brain stimulation for ET has become a widely utilized therapeutic intervention for patients, and the bilateral thalamic ventralis intermedius (VIM) is most commonly implanted. However, it has been noted that in some patients gait ataxia significantly worsens post-op. This initially was thought to be a result of disease progression, but recent studies have in fact shown that this is a DBS related phenomenon.
Methods: Participants will have two visits to either the Portland VA or Oregon Health \& Science University (OHSU). At each visit, several assessments of balance, tremor, gait and balance, and DBS settings will be made. The gait and balance assessments will be performed by a unblinded and a blinded rater.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| ET (DBS-, Ataxia+) | – | Other: No interventionEssential Tremor without DBS with Ataxia on examination |
| ET (DBS-, Ataxia-) | – | Other: No interventionEssential Tremor without DBS and without Ataxia on examination |
| ET (DBS+, Ataxia+) | – | Other: No interventionEssential Tremor with DBS with Ataxia on examination |
| ET (DBS+, Ataxia-) | – | Other: No interventionEssential Tremor with DBS without Ataxia |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Essential Tremor participants with and without ataxia
Key inclusion criteria (4 listed)
- Essential Tremor diagnosis at least 3 years duration
- Absence of other neurological signes (such as dystonia, ataxia, or Parkinsonism)
- Patients must be able to walk 2 minutes unassisted.
- Patients must be able to understand and consent to be in the study.
Key exclusion criteria (7 listed)
- Patients who have had changes in DBS settings within the last 3 months.
- Patients who have had no initial improvement or response to DBS.
- ET medication changes in the last month.
- Actively abusing alcohol.
- A neurologic diagnosis other than ET that in the investigator's opinion could affect gait and/or balance.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionNo interventions - Observational study | Other | ET (DBS+, Ataxia+), ET (DBS+, Ataxia-), ET (DBS-, Ataxia+), ET (DBS-, Ataxia-) |
Primary outcome
Ataxia Differences between DBS and no DBS
Time frame: Visit 2 (after DBS has been turned off for 3-10 days)
Compare the Scale of the Assessment and Rating of Ataxia (SARA) total score between DBS and no DBS participants with essential tremor. This 8-item scale rates gait (0-8 points), stance (0-6 points), sitting (0-4 points), speech disturbance (0-6 points), finger chase (0-4 points), nose-finger test (0-4 points), fast alternating hand movements (0-4 points), and heel-shin slide (0-4 points). Motor activists of the four extremities (items 5-8) assessments are performed bilaterally, mean values to obtain a total score. Cumulative score ranges from 0 (no ataxia) to 40 (most severe ataxia).
1 secondary outcome
Balance Confidence
Time frame: Visit 2 (after DBS has been turned off for 3-10 days)
Results and safety
The study was stopped early (reason given: Low enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2020.
- Background: PubMed 27423573Ramirez-Zamora A, Boggs H, Pilitsis JG. Reduction in DBS frequency improves balance difficulties after thalamic DBS for essential tremor. J Neurol Sci. 2016 Aug 15;367:122-7. doi: 10.1016/j.jns.2016.06.001. Epub 2016 Jun 2.
- Results publication: PubMed 24112892Nazzaro JM, Lyons KE, Pahwa R. Deep brain stimulation for essential tremor. Handb Clin Neurol. 2013;116:155-66. doi: 10.1016/B978-0-444-53497-2.00013-9.
- Results publication: PubMed 19452239Kronenbuerger M, Konczak J, Ziegler W, Buderath P, Frank B, Coenen VA, Kiening K, Reinacher P, Noth J, Timmann D. Balance and motor speech impairment in essential tremor. Cerebellum. 2009 Sep;8(3):389-98. doi: 10.1007/s12311-009-0111-y. Epub 2009 May 19.
- Results publication: PubMed 20926368Fasano A, Herzog J, Raethjen J, Rose FE, Muthuraman M, Volkmann J, Falk D, Elble R, Deuschl G. Gait ataxia in essential tremor is differentially modulated by thalamic stimulation. Brain. 2010 Dec;133(Pt 12):3635-48. doi: 10.1093/brain/awq267. Epub 2010 Oct 5.
- Individual participant dataSharing planned: Yes. Post data entry and verification, data and specimens will be de-identified (no 18 HIPAA identifiers and age aggregated for those > 89 years old) and transferred to the Neurological Disorder Repository (MIRB # 3129). This repository is maintained at the Portland VA Health Care System. Verification of the coded data set creation and the absence of the identifiers will be created and retained in the study files. The research coordinator will be responsible for the creation and verification process. The key to the code will be maintained by the study and will not be released to the repository. The recipient investigator must present the data use agreement, documentation of an Institutional Review Boar (IRB) approved protocol and Informed Conset Form (ICF) allowing the release of the identifiable specimens/data, or the release of coded specimens/data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Essential Tremor and Deep Brain Stimulation, run by Oregon Health and Science University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 17 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Low enrollment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ataxia Differences between DBS and no DBS (time frame: Visit 2 (after DBS has been turned off for 3-10 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03769961, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2020.