Parkinson DiseaseNCT01809613
Functional Magnetic Resonance Imaging (fMRI) During Deep Brain Stimulation (DBS) to Treat Parkinson's Disease
An observational study of Parkinson Disease and Essential Tremor, run by Mayo Clinic at 1 site in United States.
Trial summary
This study is investigating the usefulness of using functional magnetic resonance imaging (fMRI) to monitor brain activation during deep brain stimulation for Parkinson's Disease, Essential tremor, dystonia, OCD, depression, pain, Tourette's syndrome, and epilepsy. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Parkinson Disease, Essential Tremor, Dystonia
- What is being tested?
- Functional Magnetic Resonance Imaging (fMRI)
- Type of treatment
- Surgery or procedure
- How many people
- 88 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2013to 27 Jul 2017
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients approved and scheduled to undergo the clinical procedure of Deep Brain stimulation.
Who may be able to join
- Adult Patients with medically intractable Parkinson's Disease who have been approved for DBS surgery by the interdisciplinary Mayo DBS committee.
Who cannot join
- Pregnant patients, prisoners, children (age less than 18), and any patients identified as unsuitable for this protocol by the Mayo DBS committee.
Trial locations and contacts
1 site in 1 country.
About this study
This study is investigating the usefulness of using functional magnetic resonance imaging (fMRI) to monitor brain activation during deep brain stimulation for Parkinson's Disease, Essential tremor, dystonia, OCD, depression, pain, Tourette's syndrome, and epilepsy. The study may determine the relationship between patterns of brain activation and therapeutic outcome and/or side effects.
Read the detailed description
Deep brain stimulation (DBS) is an effective neurosurgical approach for treating motor disorders including Parkinson's disease (PD), Essential Tremor (ET), and dystonia. Its therapeutic benefit has led to the application of DBS to a wide spectrum of disorders including psychiatric conditions, epilepsy, Alzeimer's disease, headache, obsessive-compulsive disorder (OCD), Tourette syndrome, depression and intractable pain. However, because the nature of its underlying mechanisms and clinical effects are not fully understood, precision targeting, decreasing adverse effects, and improving clinical outcomes represent major clinical and scientific challenges in PD and other disorders treated by DBS. Our goal is to investigate the inter-relationships between site-specific neural activation and clinical outcomes during DBS. To do so, we will perform non-invasive functional Magnetic Resonance Imaging (fMRI) to investigate DBS-mediated activation of neural network circuitry. Our proposed protocol involves the addition of intraoperative fMRI to the standard DBS or battery change protocol in order to determine the major sites of activation during application of clinically effective DBS to the subthalamic nucleus (STN), ventral intermediate thalamus (VIM), globus pallidus interna (GPi), fornix, nucleus accumbens (NAc), anterior thalamus and periaqueductal gray matter. Patients will undergo clinical assessment to determine the relative efficacy of DBS stimulation parameters, applied during the fMRI and at regularly scheduled post-operative programming visits up to 6 months of follow-up. Our Specific Aims are to: (1) Identify fMRI-activated brain regions by DBS in patients who undergo DBS surgery (Patients diagnosed with PD, ET, dystonia, OCD, depression, pain, Tourette's syndrome, and epilepsy. (2) Correlate fMRI activation with clinical outcomes and side effects. With the goal of improving DBS electrode targeting for optimal and reproducible clinical outcomes, these experiments will be the first attempt to relate site-specific DBS with functional in vivo imaging data and quantitative longitudinal clinical outcome measures in DBS patients.
- Being tested
- Functional Magnetic Resonance Imaging (fMRI)
- Keywords
- Parkinson disease, Deep Brain Stimulation, Functional Magnetic Resonance Imaging
- Medical subject headings
- Parkinson Disease, Essential Tremor, Dystonia, Obsessive-Compulsive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functional Magnetic Resonance Imaging (fMRI)Procedure or surgery
During the deep brain stimulation (DBS) surgery of the subthalamic nucleus within the thalamocortical basal ganglion, an additional lead extendor will be connected to the DBS electrode to allow externalization of the lead. Following confirmation of electrode location with MRI, a series of fMRI scans will be run. Total scanning time will be limited to 35 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Deep Brain Stimulation | Functional Magnetic Resonance Imaging (fMRI) will be performed to determine the areas of BOLD signal modulation with DBS. Receives: Procedure: Functional Magnetic Resonance Imaging (fMRI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Score on Unified Parkinson's Disease Rating Scale (UPDRS)
The UPDRS is a rating scale used to follow the longitudinal course of Parkinson's disease. The version of the scale used in this study has a total of 14 items; each of these item has a scale of 0-4, with 0 being no impairment, and 4 being severe impairment. All of the parts are combined to give a numeric score: 0 indicating no sign of disease, and 56, the highest score indicating severely incapacitated.
Measured: 6 months after Deep Brain Stimulation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2013 (estimated)
- Study startMar 2013
- Primary completion27 Jul 2017
- Study completion27 Jul 2017
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 Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kendall H. Lee, Mayo Clinic
- Investigators
- Kendall Lee, MD, PhD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01809613
- Sponsor's protocol ID
- 12-009020
- Status last verified
- Aug 2017
- First submitted
- 11 Mar 2013
- Last updated
- 3 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Knight EJ, Testini P, Min HK, Gibson WS, Gorny KR, Favazza CP, Felmlee JP, Kim I, Welker KM, Clayton DA, Klassen BT, Chang SY, Lee KH. Motor and Nonmotor Circuitry Activation Induced by Subthalamic Nucleus Deep Brain Stimulation in Patients With Parkinson Disease: Intraoperative Functional Magnetic Resonance Imaging for Deep Brain Stimulation. Mayo Clin Proc. 2015 Jun;90(6):773-85. doi: 10.1016/j.mayocp.2015.03.022.
PubMed 26046412
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Magnetic Resonance Imaging (fMRI) During Deep Brain Stimulation (DBS) to Treat Parkinson's Disease
- ClinicalTrials.gov ID
- NCT01809613
- Acronym / sponsor ID
- 12-009020
- Keywords
- Parkinson disease, Deep Brain Stimulation, Functional Magnetic Resonance Imaging
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- 27 Jul 2017 (actual)
- Study completion
- 27 Jul 2017 (actual)
- First posted
- 13 Mar 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.
This study is investigating the usefulness of using functional magnetic resonance imaging (fMRI) to monitor brain activation during deep brain stimulation for Parkinson's Disease, Essential tremor, dystonia, OCD, depression, pain, Tourette's syndrome, and epilepsy. The study may determine the relationship between patterns of brain activation and therapeutic outcome and/or side effects.
Detailed description
Deep brain stimulation (DBS) is an effective neurosurgical approach for treating motor disorders including Parkinson's disease (PD), Essential Tremor (ET), and dystonia. Its therapeutic benefit has led to the application of DBS to a wide spectrum of disorders including psychiatric conditions, epilepsy, Alzeimer's disease, headache, obsessive-compulsive disorder (OCD), Tourette syndrome, depression and intractable pain. However, because the nature of its underlying mechanisms and clinical effects are not fully understood, precision targeting, decreasing adverse effects, and improving clinical outcomes represent major clinical and scientific challenges in PD and other disorders treated by DBS. Our goal is to investigate the inter-relationships between site-specific neural activation and clinical outcomes during DBS. To do so, we will perform non-invasive functional Magnetic Resonance Imaging (fMRI) to investigate DBS-mediated activation of neural network circuitry. Our proposed protocol involves the addition of intraoperative fMRI to the standard DBS or battery change protocol in order to determine the major sites of activation during application of clinically effective DBS to the subthalamic nucleus (STN), ventral intermediate thalamus (VIM), globus pallidus interna (GPi), fornix, nucleus accumbens (NAc), anterior thalamus and periaqueductal gray matter. Patients will undergo clinical assessment to determine the relative efficacy of DBS stimulation parameters, applied during the fMRI and at regularly scheduled post-operative programming visits up to 6 months of follow-up. Our Specific Aims are to: (1) Identify fMRI-activated brain regions by DBS in patients who undergo DBS surgery (Patients diagnosed with PD, ET, dystonia, OCD, depression, pain, Tourette's syndrome, and epilepsy. (2) Correlate fMRI activation with clinical outcomes and side effects. With the goal of improving DBS electrode targeting for optimal and reproducible clinical outcomes, these experiments will be the first attempt to relate site-specific DBS with functional in vivo imaging data and quantitative longitudinal clinical outcome measures in DBS patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Deep Brain Stimulation | – | Procedure: Functional Magnetic Resonance Imaging (fMRI)Functional Magnetic Resonance Imaging (fMRI) will be performed to determine the areas of BOLD signal modulation with DBS. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients approved and scheduled to undergo the clinical procedure of Deep Brain stimulation.
Key inclusion criteria (1 listed)
- Adult Patients with medically intractable Parkinson's Disease who have been approved for DBS surgery by the interdisciplinary Mayo DBS committee.
Key exclusion criteria (1 listed)
- Pregnant patients, prisoners, children (age less than 18), and any patients identified as unsuitable for this protocol by the Mayo DBS committee.
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 |
|---|---|---|
| Functional Magnetic Resonance Imaging (fMRI)During the deep brain stimulation (DBS) surgery of the subthalamic nucleus within the thalamocortical basal ganglion, an additional lead extendor will be connected to the DBS electrode to allow externalization of the lead. Following confirmation of electrode location with MRI, a series of fMRI scans will be run. Total scanning time will be limited to 35 minutes. | Procedure or surgery | Deep Brain Stimulation |
Primary outcome
Mean Score on Unified Parkinson's Disease Rating Scale (UPDRS)
Time frame: 6 months after Deep Brain Stimulation
The UPDRS is a rating scale used to follow the longitudinal course of Parkinson's disease. The version of the scale used in this study has a total of 14 items; each of these item has a scale of 0-4, with 0 being no impairment, and 4 being severe impairment. All of the parts are combined to give a numeric score: 0 indicating no sign of disease, and 56, the highest score indicating severely incapacitated.
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 3 Aug 2017.
- Derived from this study: PubMed 26046412Knight EJ, Testini P, Min HK, Gibson WS, Gorny KR, Favazza CP, Felmlee JP, Kim I, Welker KM, Clayton DA, Klassen BT, Chang SY, Lee KH. Motor and Nonmotor Circuitry Activation Induced by Subthalamic Nucleus Deep Brain Stimulation in Patients With Parkinson Disease: Intraoperative Functional Magnetic Resonance Imaging for Deep Brain Stimulation. Mayo Clin Proc. 2015 Jun;90(6):773-85. doi: 10.1016/j.mayocp.2015.03.022.
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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.
Kendall Lee, MD, PhD principal investigator
Mayo Clinic
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 Parkinson Disease and Essential Tremor, run by Mayo Clinic 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 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 3 Aug 2017. 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. 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?
Mean Score on Unified Parkinson's Disease Rating Scale (UPDRS) (time frame: 6 months after Deep Brain Stimulation). 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 NCT01809613, 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 3 Aug 2017.