Essential TremorNCT05177900
Interphase Gap in Biphasic Stimulation in DBS for ET
A study testing Study Tool Computer in people with Essential Tremor, run by Myles Mc Laughlin at 1 site in Belgium.
Trial summary
Deep Brain Stimulation (DBS) is a well established therapy in medication-refractory essential tremor (ET). Since the inception of DBS, cathodic pulses are used. Recent work suggests that biphasic pulses influence the therapeutic window when compared to cathodic pulses, when tested acutely. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Essential Tremor
- What is being tested?
- Study Tool Computer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Dec 2021to 27 Jan 2022
- 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 essential tremor treated with Vim-DBS
- Normal impedances of DBS circuit
- Signed written informed consent
Who cannot join
- Active psychiatric disease or active alcohol or drug abuse
- Dementia
- History of recurrent or unprovoked seizures
- Relevant comorbidities that influence objective clinical assessment
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigating the Use of an Interphase Gap in Biphasic Pulses in DBS for ET Patients
Deep Brain Stimulation (DBS) is a well established therapy in medication-refractory essential tremor (ET). Since the inception of DBS, cathodic pulses are used. Recent work suggests that biphasic pulses influence the therapeutic window when compared to cathodic pulses, when tested acutely. Animal studies and work from cochlear implants, show that the use of an interphase gap, influences the generation of action potentials. In this study, the goal is to investigate the use of an interphase gap in biphasic pulses in DBS for ET patients.
- Conditions
- Essential Tremor
- Being tested
- Study Tool Computer
- Medical subject headings
- Essential Tremor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Study Tool ComputerDevice
Nonconventional pulses delivered with custom-ware designed by Boston Scientific
| Study group | Role | What they receive |
|---|---|---|
| Biphasic pulse without interphase gap | Active comparator | Not described Receives: Device: Study Tool Computer |
| Biphasic pulse with interphase gap | Experimental | Not described Receives: Device: Study Tool Computer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Therapeutic threshold (mA)
Amplitude needed to elicit tremor arrest, expressed in milliamperes (mA)
Measured: During uptitration of the amplitude (entire process takes 3-4 minutes)
Side effect threshold (mA)
Amplitude needed to elicit non-transient side effects, expressed in milliamperes (mA)
Measured: During uptitration of the amplitude (entire process takes 3-4 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2022
- Study start1 Dec 2021
- Primary completion27 Jan 2022
- Study completion27 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Essential TremorStudies of the same condition, open and under way.
- 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
- Crossover
- Model description
- The patient will be allocated to the both arms in a cross-over design (no interphase gap and interphase gaps of different lenghts). The order of the pulses will be delivered in a random order, and with a double-blind design. Of all pulses, the therapeutic window will be assessed acutely (3 times per pulse shape).
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Myles Mc Laughlin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Myles Mc Laughlin, KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05177900
- Sponsor's protocol ID
- s61020_IPG
- Status last verified
- Apr 2022
- First submitted
- 2 Dec 2021
- Last updated
- 6 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Boogers A, Peeters J, Van Bogaert T, De Vloo P, Vandenberghe W, Nuttin B, Mc Laughlin M. Interphase Gaps in Symmetric Biphasic Pulses Reduce the Therapeutic Window in Ventral Intermediate Nucleus of the Thalamus-Deep Brain Stimulation for Essential Tremor. Neuromodulation. 2023 Dec;26(8):1699-1704. doi: 10.1016/j.neurom.2022.09.012. Epub 2022 Nov 18.
PubMed 36404213
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Use of an Interphase Gap in Biphasic Pulses in DBS for ET Patients
- ClinicalTrials.gov ID
- NCT05177900
- Acronym / sponsor ID
- s61020_IPG
- Conditions
- Essential Tremor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Myles Mc LaughlinUniversity, hospital or other
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 27 Jan 2022 (actual)
- Study completion
- 27 Jan 2022 (actual)
- First posted
- 5 Jan 2022 (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.
Deep Brain Stimulation (DBS) is a well established therapy in medication-refractory essential tremor (ET). Since the inception of DBS, cathodic pulses are used. Recent work suggests that biphasic pulses influence the therapeutic window when compared to cathodic pulses, when tested acutely. Animal studies and work from cochlear implants, show that the use of an interphase gap, influences the generation of action potentials. In this study, the goal is to investigate the use of an interphase gap in biphasic pulses in DBS for ET patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- The patient will be allocated to the both arms in a cross-over design (no interphase gap and interphase gaps of different lenghts). The order of the pulses will be delivered in a random order, and with a double-blind design. Of all pulses, the therapeutic window will be assessed acutely (3 times per pulse shape).
| Arm | Type | Receives |
|---|---|---|
| Biphasic pulse without interphase gap | Active comparator | Device: Study Tool Computer |
| Biphasic pulse with interphase gap | Experimental | Device: Study Tool Computer |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with essential tremor treated with Vim-DBS
- Normal impedances of DBS circuit
- Signed written informed consent
Key exclusion criteria (5 listed)
- Active psychiatric disease or active alcohol or drug abuse
- Dementia
- History of recurrent or unprovoked seizures
- Relevant comorbidities that influence objective clinical assessment
- Pregnancy
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 |
|---|---|---|
| Study Tool ComputerNonconventional pulses delivered with custom-ware designed by Boston Scientific | Device | Biphasic pulse with interphase gap, Biphasic pulse without interphase gap |
Primary outcome
Therapeutic threshold (mA)
Time frame: During uptitration of the amplitude (entire process takes 3-4 minutes)
Amplitude needed to elicit tremor arrest, expressed in milliamperes (mA)
Side effect threshold (mA)
Time frame: During uptitration of the amplitude (entire process takes 3-4 minutes)
Amplitude needed to elicit non-transient side effects, expressed in milliamperes (mA)
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 6 Apr 2022.
- Derived from this study: PubMed 36404213Boogers A, Peeters J, Van Bogaert T, De Vloo P, Vandenberghe W, Nuttin B, Mc Laughlin M. Interphase Gaps in Symmetric Biphasic Pulses Reduce the Therapeutic Window in Ventral Intermediate Nucleus of the Thalamus-Deep Brain Stimulation for Essential Tremor. Neuromodulation. 2023 Dec;26(8):1699-1704. doi: 10.1016/j.neurom.2022.09.012. Epub 2022 Nov 18.
- Individual participant dataSharing planned: No
Related trials for Essential Tremor
RecruitingPhase 2
Study of AGN-151607-DP to Assess Adverse Events and Change in Disease Activity in Adult Participants With Upper Limb Essential Tremor
Upper Limb Essential Tremor
Recruiting
Deep Brain Stimulation Surgery for Movement Disorders
Parkinson's Disease, Essential Tremor
RecruitingObservational study
Phenotype/Genotype Correlations in Movement Disorders
Movement Disorder
RecruitingObservational study
Analysis of Cutaneous Phosphorylated Alpha-Synuclein to Identify Patients at Risk of Progressing From Essential Tremor to Parkinson's Disease
Essential Tremor, Movement Disorders, Essential Tremor
RecruitingPhase 2
Stereotactic Radiosurgery in the Treatment of Essential Tremor
Essential Tremor
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Study Tool Computer in people with Essential Tremor, run by Myles Mc Laughlin at 1 site in Belgium.
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 3 inclusion and 5 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 6 Apr 2022. 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 Belgium. 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 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?
Therapeutic threshold (mA) (time frame: During uptitration of the amplitude (entire process takes 3-4 minutes)). The study lists 2 primary outcomes in all. 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 NCT05177900, which also lists 1 linked publication.
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 6 Apr 2022.