Movement DisordersNCT01975532
Evaluation of Diffusion MRI as a Tool in Planning Deep Brain Stimulation (DBS)
An observational study of Movement Disorders, run by University of Aarhus.
Trial summary
The purpose of this study is to explore the relationship between deep brain stimulation implantation site and DTI (diffusion tensor imaging) derived measures for the region and later compare this to the clinical treatment outcomes. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Movement Disorders
- How many people
- 13 participants
- Where
- No sites listed yet
- Study dates
- Nov 2013to Jun 2015
- 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
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients screened and deemed eligible for treatment with Deep Brain Stimulation
Who may be able to join
- Deep Brian Stimulation surgery
Who cannot join
- DBS treatment stopped before 12 month followup
About this study
Official title: Evaluation of MRI Based Fiber Tracking as a Tool in Deep Brain Stimulation for Movement Disorders
The purpose of this study is to explore the relationship between deep brain stimulation implantation site and DTI (diffusion tensor imaging) derived measures for the region and later compare this to the clinical treatment outcomes.
- Conditions
- Movement Disorders
- Medical subject headings
- Movement Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
UPDRS (unified parkinson disease rating scale) score
Measured: patients will be followed from pre-surgical evaluation to 1 year after surgery, roughly 13-14 months
Secondary outcomes (1)
Cognitive scores on neuropsychological exam
Measured: patients will be followed from per-surgical evaluation to 1 year after surgery, roughly 13-14 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2013 (estimated)
- Study startNov 2013
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Movement DisordersStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mikkel Petersen, phd-student, Principal investigator, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01975532
- Sponsor's protocol ID
- 26-MRI-DTI-on-DBS
- Status last verified
- Dec 2015
- First submitted
- 22 Oct 2013
- Last updated
- 7 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of MRI Based Fiber Tracking as a Tool in Deep Brain Stimulation for Movement Disorders
- ClinicalTrials.gov ID
- NCT01975532
- Acronym / sponsor ID
- 26-MRI-DTI-on-DBS
- Conditions
- Movement Disorders
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 4 Nov 2013 (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 explore the relationship between deep brain stimulation implantation site and DTI (diffusion tensor imaging) derived measures for the region and later compare this to the clinical treatment outcomes.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients screened and deemed eligible for treatment with Deep Brain Stimulation
Key inclusion criteria (1 listed)
- Deep Brian Stimulation surgery
Key exclusion criteria (1 listed)
- DBS treatment stopped before 12 month followup
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
UPDRS (unified parkinson disease rating scale) score
Time frame: patients will be followed from pre-surgical evaluation to 1 year after surgery, roughly 13-14 months
1 secondary outcome
Cognitive scores on neuropsychological exam
Time frame: patients will be followed from per-surgical evaluation to 1 year after surgery, roughly 13-14 months
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 7 Dec 2015.
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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.
Mikkel Petersen, phd-student principal investigator
Aarhus University Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Movement Disorders, run by University of Aarhus.
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 1 inclusion and 1 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 7 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
UPDRS (unified parkinson disease rating scale) score (time frame: patients will be followed from pre-surgical evaluation to 1 year after surgery, roughly 13-14 months). 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 7 Dec 2015; AzTrials last refreshed its copy on 31 Oct 2026.