Essential TremorAltStim DBSNCT02947841
The Effectiveness of Alternating Stimulation in Preventing Tolerance in Essential Tremor Patients
A study testing Alternating stimulation in people with Essential Tremor and Deep Brain Stimulation, run by Oregon Health and Science University at 1 site in United States.
Trial summary
The purpose of this study is to investigate the hypothesis that alternating DBS parameters on a weekly basis will prevent tolerance to stimulation and thus waning of benefit, compared with non-alternating stimulation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Essential Tremor, Deep Brain Stimulation
- What is being tested?
- Alternating stimulation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2016to Jul 2017
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with clinically diagnosed ET who have had placement of VIM DBS and are willing to undergo a baseline programming visit and 12-week follow-up assessment
- At least initial benefit from VIM DBS as judged by patient report and clinician exam
- VIM DBS placement no less than three months from entry into study
- Patients must demonstrate ability to use patient programmer to switch between group settings on a weekly basis
- Ability to wear wrist monitor for 2 week intervals, twice during the study 6. Patients with the following IPG types: Activa PC, SC or RC
Who cannot join
- Atypical tremor disorder including but not limited to tremor due to multiple sclerosis, medication-induced tremor, Parkinson's disease or parkinsonian syndrome
- DBS placement complicated by infection, hemorrhage or stroke
- Previous thalamotomy (either stereotactic, gamma knife or focused ultrasound) or previous DBS surgery resulting in explantation and reimplantation
- Known incorrect or poor lead placement
- Inability to change group settings on a weekly basis at least 75% of the time
- Inability to tolerate 12-week period without additional programming changes, including voltage stimulation adjustment
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- Inability to tolerate 12-week period without adjustment of anti-tremor medications, including primidone, beta-blockers, gabapentin, topiramate and/or benzodiazepines
- Battery voltage < or equal to 2.70V
- Patient with the following IPG types: Soletra, Kinetra or Itrel
- Inability to tolerate two group settings due to side effects or lack of efficacy
Trial locations and contacts
1 site in 1 country.
United States1 site
Oregon Health Science and University
Portland, Oregon, 97239-3098
About this study
Official title: The Effectiveness of Alternating Ventral Intermediate Nucleus Deep Brain Stimulation Parameters in Preventing Tolerance in Essential Tremor Patients
The purpose of this study is to investigate the hypothesis that alternating DBS parameters on a weekly basis will prevent tolerance to stimulation and thus waning of benefit, compared with non-alternating stimulation. The primary endpoint will be preserved tremor control with the alternating group compared with standard treatment using the Tremor Research Group Essential Tremor Rating Assessment Scale (TETRAS). Key secondary endpoints will be preserved activities of daily living measures as well as preserved tremor control as quantified by motion sensor data.
This study has one primary aim: To determine if alternating DBS stimulation parameters on a weekly basis will be superior at preserving tremor control compared with usual stimulation (non-alternating stimulation) in ET patients with VIM DBS.
- Conditions
- Essential Tremor, Deep Brain Stimulation
- Being tested
- Alternating stimulation, Placebo
- Medical subject headings
- Essential Tremor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alternating stimulationOther
Two different, but equally efficacious, settings will be determined for each subject. The settings will differ by a minimum of two of the following parameters: electrode configuration, voltage, frequency and pulse width. The different settings will be named Setting A and Setting B. The treatment cohort will receive both Setting A and Setting B that will differ by the parameters listed above.
PlaceboOther
The control cohort will receive Setting A but Setting B will be identical to Setting A.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | In the placebo cohort, subjects will alternate their DBS parameters between group A and group B every week for 12 weeks, but they will be blinded to the fact that their group A and group B are equivalent. Receives: Other: Placebo |
| Treatment | Active comparator | In the treatment cohort, subjects will alternate their DBS parameters between group A and group B every week for 12 weeks. Receives: Other: Alternating stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline Tremor Research Group Essential Tremor Rating Assessment Scale (TETRAS) performance sub scale at 12 weeks
Measured: Through study completion, 12 weeks
Secondary outcomes (2)
Change in TETRAS ADLs scale at 12 weeks
Measured: Through study completion, at 12 weeks
Motion sensor data to detect tremor
Patients will wear motion sensor device to detect tremor characteristics
Measured: Two weeks after initial visit; and again at weeks 10-12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2016 (estimated)
- Study startOct 2016
- Primary completionJun 2017
- Study completionJul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shannon Anderson, Oregon Health and Science University
- Investigators
- Shannon D Anderson, MPAS, PA-C, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02947841
- Sponsor's protocol ID
- 00015871
- Acronym
- AltStim DBS
- Status last verified
- Sep 2018
- First submitted
- 24 Oct 2016
- Last updated
- 21 Sep 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Baizabal-Carvallo JF, Kagnoff MN, Jimenez-Shahed J, Fekete R, Jankovic J. The safety and efficacy of thalamic deep brain stimulation in essential tremor: 10 years and beyond. J Neurol Neurosurg Psychiatry. 2014 May;85(5):567-72. doi: 10.1136/jnnp-2013-304943. Epub 2013 Oct 4.
PubMed 24096713Barbe MT, Liebhart L, Runge M, Pauls KA, Wojtecki L, Schnitzler A, Allert N, Fink GR, Sturm V, Maarouf M, Timmermann L. Deep brain stimulation in the nucleus ventralis intermedius in patients with essential tremor: habituation of tremor suppression. J Neurol. 2011 Mar;258(3):434-9. doi: 10.1007/s00415-010-5773-3. Epub 2010 Oct 8.
PubMed 20927533Zhang K, Bhatia S, Oh MY, Cohen D, Angle C, Whiting D. Long-term results of thalamic deep brain stimulation for essential tremor. J Neurosurg. 2010 Jun;112(6):1271-6. doi: 10.3171/2009.10.JNS09371.
PubMed 19911883Shih LC, LaFaver K, Lim C, Papavassiliou E, Tarsy D. Loss of benefit in VIM thalamic deep brain stimulation (DBS) for essential tremor (ET): how prevalent is it? Parkinsonism Relat Disord. 2013 Jul;19(7):676-9. doi: 10.1016/j.parkreldis.2013.03.006. Epub 2013 Apr 11.
PubMed 23582712Pilitsis JG, Metman LV, Toleikis JR, Hughes LE, Sani SB, Bakay RA. Factors involved in long-term efficacy of deep brain stimulation of the thalamus for essential tremor. J Neurosurg. 2008 Oct;109(4):640-6. doi: 10.3171/JNS/2008/109/10/0640.
PubMed 18826350
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Alternating Ventral Intermediate Nucleus Deep Brain Stimulation Parameters in Preventing Tolerance in Essential Tremor Patients
- ClinicalTrials.gov ID
- NCT02947841
- Acronym / sponsor ID
- AltStim DBS / 00015871
- Conditions
- Essential Tremor, Deep Brain Stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Study start
- Oct 2016
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 28 Oct 2016 (estimated)
- 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 purpose of this study is to investigate the hypothesis that alternating DBS parameters on a weekly basis will prevent tolerance to stimulation and thus waning of benefit, compared with non-alternating stimulation. The primary endpoint will be preserved tremor control with the alternating group compared with standard treatment using the Tremor Research Group Essential Tremor Rating Assessment Scale (TETRAS). Key secondary endpoints will be preserved activities of daily living measures as well as preserved tremor control as quantified by motion sensor data.
This study has one primary aim: To determine if alternating DBS stimulation parameters on a weekly basis will be superior at preserving tremor control compared with usual stimulation (non-alternating stimulation) in ET patients with VIM DBS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Other: PlaceboIn the placebo cohort, subjects will alternate their DBS parameters between group A and group B every week for 12 weeks, but they will be blinded to the fact that their group A and group B are equivalent. |
| Treatment | Active comparator | Other: Alternating stimulationIn the treatment cohort, subjects will alternate their DBS parameters between group A and group B every week for 12 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with clinically diagnosed ET who have had placement of VIM DBS and are willing to undergo a baseline programming visit and 12-week follow-up assessment
- At least initial benefit from VIM DBS as judged by patient report and clinician exam
- VIM DBS placement no less than three months from entry into study
- Patients must demonstrate ability to use patient programmer to switch between group settings on a weekly basis
- Ability to wear wrist monitor for 2 week intervals, twice during the study 6. Patients with the following IPG types: Activa PC, SC or RC
Key exclusion criteria (10 listed)
- Atypical tremor disorder including but not limited to tremor due to multiple sclerosis, medication-induced tremor, Parkinson's disease or parkinsonian syndrome
- DBS placement complicated by infection, hemorrhage or stroke
- Previous thalamotomy (either stereotactic, gamma knife or focused ultrasound) or previous DBS surgery resulting in explantation and reimplantation
- Known incorrect or poor lead placement
- Inability to change group settings on a weekly basis at least 75% of the time
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 |
|---|---|---|
| Alternating stimulationTwo different, but equally efficacious, settings will be determined for each subject. The settings will differ by a minimum of two of the following parameters: electrode configuration, voltage, frequency and pulse width. The different settings will be named Setting A and Setting B. The treatment cohort will receive both Setting A and Setting B that will differ by the parameters listed above. | Other | Treatment |
| PlaceboThe control cohort will receive Setting A but Setting B will be identical to Setting A. | Other | Placebo |
Primary outcome
Change from baseline Tremor Research Group Essential Tremor Rating Assessment Scale (TETRAS) performance sub scale at 12 weeks
Time frame: Through study completion, 12 weeks
2 secondary outcomes
Change in TETRAS ADLs scale at 12 weeks
Time frame: Through study completion, at 12 weeks
Motion sensor data to detect tremor
Time frame: Two weeks after initial visit; and again at weeks 10-12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2018.
- Background: PubMed 24096713Baizabal-Carvallo JF, Kagnoff MN, Jimenez-Shahed J, Fekete R, Jankovic J. The safety and efficacy of thalamic deep brain stimulation in essential tremor: 10 years and beyond. J Neurol Neurosurg Psychiatry. 2014 May;85(5):567-72. doi: 10.1136/jnnp-2013-304943. Epub 2013 Oct 4.
- Background: PubMed 20927533Barbe MT, Liebhart L, Runge M, Pauls KA, Wojtecki L, Schnitzler A, Allert N, Fink GR, Sturm V, Maarouf M, Timmermann L. Deep brain stimulation in the nucleus ventralis intermedius in patients with essential tremor: habituation of tremor suppression. J Neurol. 2011 Mar;258(3):434-9. doi: 10.1007/s00415-010-5773-3. Epub 2010 Oct 8.
- Background: PubMed 19911883Zhang K, Bhatia S, Oh MY, Cohen D, Angle C, Whiting D. Long-term results of thalamic deep brain stimulation for essential tremor. J Neurosurg. 2010 Jun;112(6):1271-6. doi: 10.3171/2009.10.JNS09371.
- Background: PubMed 23582712Shih LC, LaFaver K, Lim C, Papavassiliou E, Tarsy D. Loss of benefit in VIM thalamic deep brain stimulation (DBS) for essential tremor (ET): how prevalent is it? Parkinsonism Relat Disord. 2013 Jul;19(7):676-9. doi: 10.1016/j.parkreldis.2013.03.006. Epub 2013 Apr 11.
- Background: PubMed 18826350Pilitsis JG, Metman LV, Toleikis JR, Hughes LE, Sani SB, Bakay RA. Factors involved in long-term efficacy of deep brain stimulation of the thalamus for essential tremor. J Neurosurg. 2008 Oct;109(4):640-6. doi: 10.3171/JNS/2008/109/10/0640.
- Individual participant dataSharing planned: No
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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.
Shannon D Anderson, MPAS, PA-C principal investigator
Oregon Health and Science University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Alternating stimulation in people with Essential Tremor and Deep Brain Stimulation, run by Oregon Health and Science University at 1 site 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 5 inclusion and 10 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: finished, as of the sponsor's last update on 21 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. Some participants in this study may receive a placebo. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change from baseline Tremor Research Group Essential Tremor Rating Assessment Scale (TETRAS) performance sub scale at 12 weeks (time frame: Through study completion, 12 weeks). 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 NCT02947841, which also lists 5 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 21 Sep 2018.