Deep Brain Stimulation Therapy in Movement Disorders

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-100
SponsorNational Institute of Neurological Disorders and Stroke (NINDS)

About this trial

Background:

\- In deep brain stimulation (DBS), a device called a neurostimulator is placed in the chest. It is attached to wires in parts of the brain that affect movement. DBS might help people with movement disorders like Parkinson s disease (PD), dystonia, and essential tremor (ET).

Objective:

\- To provide DBS treatment to people with some movement disorders.

Eligibility:

\- Adults 18 years and older with PD, ET, or certain forms of dystonia.

Design:

* Participants will be screened with medical history and physical exam. They will have blood and urine tests and: * MRI brain scan. The participant will lie on a table that slides in and out of a metal cylinder with a magnetic field. They will be in the scanner about 60 minutes. They will get earplugs for the loud noises. During part of the MRI, a needle will guide a thin plastic tube into an arm vein and a dye will be injected. * Electrocardiogram. Metal disks or sticky pads will be placed on the chest, arms, and legs. They record heart activity. * Chest X-ray. * Tests of memory, attention, concentration, thinking, and movement. * Eligible participants will have DBS surgery. The surgery and hospital care afterward are NOT part of this protocol. * Study doctors will see participants 3 4 weeks after surgery to turn on the neurostimulator. * Participants will return every month for 3 months, then every 3 months during the first year, and every 6 months during the second year. Each time, participants will be examined and answer questions. DBS placement will be evaluated with MRI. The neurostimulator will be programmed. At two visits, participants will have tests of movements, thinking, and memory....

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Be 18 years of age or older.

Able to comply with study procedures and provide informed consent.

The diagnosis of idiopathic PD will be based on the UK Brain Bank Criteria, and confirmed by the Movement Disorders Neurologists in the NIH Parkinson Clinic.

The diagnosis of primary (generalized or segmental), hemidystonia, or cervical dystonia will be confirmed on clinical examination in the NIH Movement Disorders Clinic.

Disqualifiers

Clinically significant medical disease that would increase the risk of developing pre- or postoperative complications, including but not limited to uncontrolled systemic hypertension with values above 170/100; unstable heart disease; unstable respiratory disease; uncorrected coagulation abnormalities or need for therapeutic anticoagulation which cannot be interrupted;

History of stroke, exposure to toxins, neuroleptics, or encephalitis

Neurologic signs of upper motor neuron or cerebellar involvement, supranuclear gaze palsy, or multiple systems atrophy.

MR-imaging with evidence indicative of secondary disease such as tumor, or stroke, which could cause the movement disorder.

Trial design

Design model

Single group

Treatments tested in this trial

  • Deep Brain Stimulation management

    Device

    The DBS surgery will be performed according to standard of care in the centers of referral. If performed at the NIH, this will be done under protocol 11-N-0211 or other protocols permitting DBS surgery depending on future availability.

Treatment groups

300 Participants
are divided into 1 treatment group
Group A: Single-armOther 1 intervention

Trial outcomes

Primary outcomes

1

To provide DBS therapy and follow-up management

a. Severity of PD motor symptoms (measured by the UPDRS III scale) b. Changes in dystonia severity (measured by the Burke-Fahn-Marsden (BFM) dystonia rating scale (Burke et al., 1985) c. Changes in tremor severity (measured by the Tremor Rating Scale (TRS)) d. Levels of effective drug therapy for PD patients using the Levodopa Equivalent Drug Dosing (LEDD) e. Changes in behavior, performance of activities of daily living and complications of therapy as measured by the UPDRS I, II, and IV scales 2. To evaluate effects of DBS before and 1 year after surgery on quality of life: a. For PD patients (measured by UPDRS part II and other scales such as the PDQ-39) b. For the Dystonia and ET patients (measured by the SF-12 scale) 3. To evaluate radiographic correlation of DBS electrode position and clinical changes 4. To evaluate neurophysiological mechanisms of DBS and relevant basal ganglia physiology

Time frame
two years
2

To maintain a cohort of patients treated with DBS who can participate in other NIH protocols addressing the efficacy of functional surgery and the relevant physiology

To potentially enroll subjects in other NIH studies.

Time frame
ongoing
3

Data collection

All the data collected will be an outcome of standard of care and all analyses will be retrospective

Time frame
ongoing

Secondary outcomes

1

To access other clinical outcome measures related to response to therapy

Data collection

Time frame
2 years
2

To correlate radiographic data related to DBS electrode position with clinical changes

Data collection

Time frame
2 years
3

To collect physiology data correlated with motor and cognitive function in these

Data collection

Time frame
2 years

Other outcomes

Sponsors and contacts

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