Spine MRI in Patients With Deep Brain Stimulation (DBS)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-01

Study Completion Date

2022-01-21

Brief Summary

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Magnetic resonance imaging (MRI) of patients implanted with deep brain stimulation (DBS) is under strict safety guidelines. Depending on the body part being imaged, the safety may vary.

Many DBS patients will need a spine MRI based on their clinical symptoms. However, the vendor safety guidelines are limiting in terms of possible MR pulse sequences. Based on phantom safety data, we designed a set of MR pulse sequences deemed as safe as possible and the protocol allows acquisition of diagnostic quality MRI images.

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Detailed Description

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The patients who clinically require a spine MRI will undergo a spine MRI with our designed protocols to obtain diagnostic quality images. Furthermore, a limited brain MRI will be done before and after to ensure no peri-electrode tissue changes.

Conditions

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Parkinson Disease Dystonia Depression Spinal Stenosis Spinal Diseases

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

This is a prospective cohort study that will enroll patients who have already undergone DBS electrode placement for a variety of disorders including, but not limited to Parkinson's disease, essential tremor, dystonia, depression, epilepsy, neuropathic pain and Alzheimer's disease. This eligible patient population is broad but unified by the fact that they have undergone DBS to treat specific circuit dysfunctions. Patients with internalized leads and IPG may be included. Patients will undergo routine clinical MRI sequences used for the spine (structural in axial and sagittal planes). The choice of imaging the cervical, thoracic or lumbar will depend on the requisition from the treating physician.

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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DBS electrode placement

Participants in this study will be patients who have already undergone surgery for implantation of DBS electrodes.

Patients who have already undergone surgery for implantation of DBS electrodes and patients for whom the treating physicians recommends (based on clinical grounds) a spine MRI (cervical, thoracic or lumbar) shall be recruited for the study.This eligible patient population is broad but unified by the fact that they have undergone DBS to treat specific circuit dysfunctions. Patients with internalized leads and IPG may be included. Patients will undergo routine clinical MRI sequences used for the spine (structural in axial and sagittal planes). The choice of imaging the cervical, thoracic or lumbar will depend on the requisition from the treating physician.

Group Type EXPERIMENTAL

MRI of the spine

Intervention Type DIAGNOSTIC_TEST

Perform a clinically indicated MRI of the spine in DBS patients

Interventions

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MRI of the spine

Perform a clinically indicated MRI of the spine in DBS patients

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Age between 18 and 85 years of age
* Participants must have undergone implantation of DBS electrodes.
* Participants must be able to understand the purpose of this research and must sign the informed consent form.
* Participants must understand that the role of this research is demonstrate the safety of spine MRI in patients with DBS.

Exclusion Criteria

* Participants who have serious cognitive or psychological impairments and cannot give informed consent.
* Participants who are unable to effectively or efficiently communicate, for example patients suffering from speech deficits (dysarthria, aphasia) or are non-English speaking.

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No