Improving Accuracy of Implanting Stimulation ElectrodesNCT03136302
Correlation of Tractography and Motor Evoked Potentials in Deep Brain Stimulation
An observational study of Improving Accuracy of Implanting Stimulation Electrodes, run by Nova Scotia Health Authority at 1 site in Canada.
Trial summary
The goal is to establish another anatomical referencing system in order to achieve an even higher accuracy when implanting stimulation electrodes. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Improving Accuracy of Implanting Stimulation Electrodes
- What is being tested?
- Deep Brain Stimulation
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- 1 Sep 2017to 1 Sep 2025
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Patients who qualify for deep brain stimulation on the basis of a movement disorder and chronic pain
Who may be able to join
- Patient qualifying for deep brain stimulation on the basis of a movement disorder (Parkinson's Disease, tremor, dystonia) or chronic pain disease.
- Informed consent
Who cannot join
- Lack of consent
- Electrical or other devices that preclude the performance of an MRI
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Queen Elizabeth Health Science Centre
Halifax, Nova Scotia, B3H3A7
Lutz Weise, MD, 902-473-6850, lutz.weise@nshealth.ca
About this study
The goal is to establish another anatomical referencing system in order to achieve an even higher accuracy when implanting stimulation electrodes.
Read the detailed description
The main goal is to find out what are the optimal distances to these reference fiber tracts when stimulating and to find the optimal target. This has to be evaluated for each target, such as globus pallidus (Gpi), subthalamic nucleus (STN) and ventral intermediate nucleus of the thalamus (VIM) separately. This is of special importance as the investigators can demonstrate the internal capsule, which is often a generator of stimulation-induced side effects: tetanic muscle contractions, dysarthria and gaze deviations.
- Being tested
- Deep Brain Stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deep Brain StimulationProcedure or surgery
Deep Brain Stimulation
| Study group | Role | What they receive |
|---|---|---|
| Subthalamic Nucleus (STN) | Patients with Parkinson's disease Receives: Procedure: Deep Brain Stimulation | |
| Globus Pallidus (Gpi) | Patients with Dystonia Receives: Procedure: Deep Brain Stimulation | |
| Ventral intermediate nucleus of the thalamus (VIM) | Patients with Tremor Receives: Procedure: Deep Brain Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
distance between stimulation electrode and motor fibers in mm
Distances between the stimulation electrode and motor fibers as depicted on fiber tracking in millimeters in correlation to the threshold current for eliciting clinical side effects
Measured: Intraoperative
Secondary outcomes (7)
Intraoperative intensity of stimulation in milliampere (mA)
Intraoperative intensity of stimulation in milliamp, which elicits an activation of contralateral muscle groups (musculus interosseus dorsalis and the musculus tibialis anterior)
Measured: Intraoperative
Stimulation thresholds in milliampere (mA)
Threshold of intraoperative stimulation intensity in milliamp, which elicits capsular side effects
Measured: Intraoperative
Change in disease score units on the UPDRS rating scale
Assessment of therapeutic effects using Unified Parkinson disease rating scale (UPDRS)
Measured: twelve months
Change in disease score units on the FTRS rating scale
Assessment of therapeutic effects using, Fahn-Tremor Rating Scale (FTRS)
Measured: twelve months
Change in disease score units on the BFMDRS rating scale
Assessment of therapeutic effects using Burke-Fahn-Marsden dystonia rating scale (BFMDRS)
Measured: twelve months
Change in disease score units on the TWSTR rating scale
Assessment of therapeutic effects using Toronto Western Spasmodic torticollis rating scale (TWSTR)
Measured: twelve months
Change in disease score units on the PDQ-39 rating scale
Assessment of therapeutic effects using Parkinsons Disease QuestionnairePDQ-39
Measured: twelve months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2017
- Study start1 Sep 2017
- Primary completion1 Sep 2025 (estimated)
- Study completion1 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Improving Accuracy of Implanting Stimulation ElectrodesStudies of the same condition, open and under way.
- More trials run by Nova Scotia Health AuthorityThe 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 only
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nova Scotia Health Authority
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lutz Weise, MD, Principal investigator, Dalhousie University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03136302
- Sponsor's protocol ID
- DBS2017
- Status last verified
- Aug 2024
- First submitted
- 25 Jan 2017
- Last updated
- 21 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation of Tractography and Motor Evoked Potentials in Deep Brain Stimulation
- ClinicalTrials.gov ID
- NCT03136302
- Acronym / sponsor ID
- DBS2017
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Nova Scotia Health AuthorityUniversity, hospital or other
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 1 Sep 2025 (estimated)
- Study completion
- 1 Sep 2025 (estimated)
- First posted
- 2 May 2017 (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 goal is to establish another anatomical referencing system in order to achieve an even higher accuracy when implanting stimulation electrodes.
Detailed description
The main goal is to find out what are the optimal distances to these reference fiber tracts when stimulating and to find the optimal target. This has to be evaluated for each target, such as globus pallidus (Gpi), subthalamic nucleus (STN) and ventral intermediate nucleus of the thalamus (VIM) separately. This is of special importance as the investigators can demonstrate the internal capsule, which is often a generator of stimulation-induced side effects: tetanic muscle contractions, dysarthria and gaze deviations.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Subthalamic Nucleus (STN) | – | Procedure: Deep Brain StimulationPatients with Parkinson's disease |
| Globus Pallidus (Gpi) | – | Procedure: Deep Brain StimulationPatients with Dystonia |
| Ventral intermediate nucleus of the thalamus (VIM) | – | Procedure: Deep Brain StimulationPatients with Tremor |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who qualify for deep brain stimulation on the basis of a movement disorder and chronic pain
Key inclusion criteria (2 listed)
- Patient qualifying for deep brain stimulation on the basis of a movement disorder (Parkinson's Disease, tremor, dystonia) or chronic pain disease.
- Informed consent
Key exclusion criteria (2 listed)
- Lack of consent
- Electrical or other devices that preclude the performance of an MRI
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 |
|---|---|---|
| Deep Brain StimulationDeep Brain Stimulation | Procedure or surgery | Globus Pallidus (Gpi), Subthalamic Nucleus (STN), Ventral intermediate nucleus of the thalamus (VIM) |
Primary outcome
distance between stimulation electrode and motor fibers in mm
Time frame: Intraoperative
Distances between the stimulation electrode and motor fibers as depicted on fiber tracking in millimeters in correlation to the threshold current for eliciting clinical side effects
7 secondary outcomes
Intraoperative intensity of stimulation in milliampere (mA)
Time frame: Intraoperative
Stimulation thresholds in milliampere (mA)
Time frame: Intraoperative
Change in disease score units on the UPDRS rating scale
Time frame: twelve months
Change in disease score units on the FTRS rating scale
Time frame: twelve months
Change in disease score units on the BFMDRS rating scale
Time frame: twelve months
Change in disease score units on the TWSTR rating scale
Time frame: twelve months
Change in disease score units on the PDQ-39 rating scale
Time frame: twelve months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2024.
- Individual participant dataSharing planned: Undecided
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.
Lutz Weise, MD principal investigator
Dalhousie University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Improving Accuracy of Implanting Stimulation Electrodes, run by Nova Scotia Health Authority at 1 site in Canada.
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 2 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 21 Aug 2024. 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 Canada. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lutz Weise, MD (902-473-6850, lutz.weise@nshealth.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
distance between stimulation electrode and motor fibers in mm (time frame: Intraoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Aug 2024.