Ignite Creation Date:
2024-05-05 @ 11:41 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00105430
Status:
COMPLETED
Last Update Posted:
2006-07-06
First Post:
2005-03-11
Brief Title:
Deep Brain Stimulation for Cervical Dystonia
Sponsor:
National Institute of Neurological Disorders and Stroke NINDS
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Deep Brain Stimulation of the Globus Pallidus Interna or the Subthalamic Nucleus for Treatment of Generalized Primary Dystonia
Status:
COMPLETED
Status Verified Date:
2006-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will evaluate the effectiveness of deep brain stimulation DBS in treating primary generalized dystonia Patients with dystonia have muscle spasms that cause uncontrolled twisting and repetitive movement or abnormal postures Medical therapies are available but not all patients get adequate relief from the abnormal movements or the pain associated with them DBS is a surgical procedure that interrupts neuronal circuits in the Gpi and STN areas of the basal ganglia of the brain that do not work correctly in patients with dystonia The surgery results in decreased movement and therefore may lessen patients symptoms and pain
Patients 7 years of age and older with generalized dystonia that does not respond to medical treatment may be eligible for this study Candidates are screened with blood and urine tests chest x-ray and an electrocardiogram in patients 35 years of age or more
Participants undergo the following tests and procedures
Magnetic resonance imaging MRI uses a magnetic field and radio waves to produce images of the brain The patient lies on a table that is moved into the scanner a narrow cylinder wearing earplugs to muffle loud knocking and thumping sounds that occur during the scanning process The procedure usually lasts about 45 to 90 minutes during which the patient is asked to lie still for up to 15 minutes at a time
Transcranial magnetic stimulation This procedure maps brain function A wire coil is held on the scalp and a brief electrical current is passed through the coil creating a magnetic pulse that stimulates the brain During the stimulation the patient may be asked to tense certain muscles slightly or perform other simple actions The stimulation may cause a twitch in muscles of the face arm or leg and the patient may hear a click and feel a pulling sensation on the skin under the coil During the stimulation electrical activity of muscles is recorded with a computer using electrodes attached to the skin with tape
Neurologic evaluation Before and after DBS the patients dystonia including voice strength and difficulty swallowing are measured with a standardized rating scale
DBS treatment Patients are randomly assigned to have electrodes implanted in either the Gpi or STN area of the basal ganglia The electrodes are what stimulate the brain in DBS therapy Before surgery a frame is secured to the patients head and an MRI scan is done DBS involves making two small incisions and two small holes in the skull opening the lining around the brain locating the Gpi or STN securing the electrodes in place and connecting them to the pulse generator that is placed under the skin below the collar bone Additionally during the surgery the patient is asked to move certain muscles The muscle activity is recorded to gain a better understanding of the physiology of movement After surgery computed tomography CT and MRI scans are done to confirm placement of the electrodes
Stimulation and evaluation After surgery patients movements are evaluated during and after stimulation The changes in movement and function are videotaped and scored according to a rating scale The optimal stimulation settings are determined and the stimulators are adjusted accordingly
Follow-up Patients are evaluated with videotaping at 1 2 3 6 12 18 and 24 months after surgery and the stimulators are adjusted as needed
Patients 7 years of age and older with generalized dystonia that does not respond to medical treatment may be eligible for this study Candidates are screened with blood and urine tests chest x-ray and an electrocardiogram in patients 35 years of age or more
Participants undergo the following tests and procedures
Magnetic resonance imaging MRI uses a magnetic field and radio waves to produce images of the brain The patient lies on a table that is moved into the scanner a narrow cylinder wearing earplugs to muffle loud knocking and thumping sounds that occur during the scanning process The procedure usually lasts about 45 to 90 minutes during which the patient is asked to lie still for up to 15 minutes at a time
Transcranial magnetic stimulation This procedure maps brain function A wire coil is held on the scalp and a brief electrical current is passed through the coil creating a magnetic pulse that stimulates the brain During the stimulation the patient may be asked to tense certain muscles slightly or perform other simple actions The stimulation may cause a twitch in muscles of the face arm or leg and the patient may hear a click and feel a pulling sensation on the skin under the coil During the stimulation electrical activity of muscles is recorded with a computer using electrodes attached to the skin with tape
Neurologic evaluation Before and after DBS the patients dystonia including voice strength and difficulty swallowing are measured with a standardized rating scale
DBS treatment Patients are randomly assigned to have electrodes implanted in either the Gpi or STN area of the basal ganglia The electrodes are what stimulate the brain in DBS therapy Before surgery a frame is secured to the patients head and an MRI scan is done DBS involves making two small incisions and two small holes in the skull opening the lining around the brain locating the Gpi or STN securing the electrodes in place and connecting them to the pulse generator that is placed under the skin below the collar bone Additionally during the surgery the patient is asked to move certain muscles The muscle activity is recorded to gain a better understanding of the physiology of movement After surgery computed tomography CT and MRI scans are done to confirm placement of the electrodes
Stimulation and evaluation After surgery patients movements are evaluated during and after stimulation The changes in movement and function are videotaped and scored according to a rating scale The optimal stimulation settings are determined and the stimulators are adjusted accordingly
Follow-up Patients are evaluated with videotaping at 1 2 3 6 12 18 and 24 months after surgery and the stimulators are adjusted as needed
Detailed Description:
OBJECTIVE
For dystonic patients who have failed medical therapy stereotactic deep brain stimulation DBS of the globus pallidus interna Gpi or subthalamic nucleus STN can provide significant symptom improvement but it is not known which site provides maximum benefit or the physiologic mechanisms by which these improvements may occur The study goals are to determine if DBS of Gpi or STN provides significant clinical improvement in patients with primary generalized dystonia whether the anatomic DBS site if either provides optimal improvement and to gain deeper insight into the underlying pathophysiology of this disorder
STUDY POPULATION
Adult and pediatric patients with medically refractory primary generalized dystonia will make-up the study population Patients with primary generalized dystonia suffer a wide range of symptoms including physical deformity speech difficulties swallowing dysfunction visual problems and intractable pain which can result in an inability to care for themselves Moreover pediatric primary generalized dystonia patients will often have abnormal skeletal development scoliosis resulting from the abnormal forces placed on the skeleton by dystonic muscle contractions
DESIGN
We propose placing DBS electrodes using microelectrode guidance bilaterally into either the Gpi or STN of medically refractory dystonia patients Physiological studies will be performed and compared with clinical changes to understand the mechanism of action of DBS and underlying pathophysiology of dystonia
OUTCOME MEASURES
Clinical effectiveness of DBS of the Gpi or STN will be measured by the Burke-Fahn-Marsden Scale BFM and monitored over time to determine the effectiveness of DBS and if there is an ideal anatomic stimulation site Electrophysiologic outcome measures will be obtained to determine the underlying pathophysiology of dystonia and the mechanism of action of DBS
For dystonic patients who have failed medical therapy stereotactic deep brain stimulation DBS of the globus pallidus interna Gpi or subthalamic nucleus STN can provide significant symptom improvement but it is not known which site provides maximum benefit or the physiologic mechanisms by which these improvements may occur The study goals are to determine if DBS of Gpi or STN provides significant clinical improvement in patients with primary generalized dystonia whether the anatomic DBS site if either provides optimal improvement and to gain deeper insight into the underlying pathophysiology of this disorder
STUDY POPULATION
Adult and pediatric patients with medically refractory primary generalized dystonia will make-up the study population Patients with primary generalized dystonia suffer a wide range of symptoms including physical deformity speech difficulties swallowing dysfunction visual problems and intractable pain which can result in an inability to care for themselves Moreover pediatric primary generalized dystonia patients will often have abnormal skeletal development scoliosis resulting from the abnormal forces placed on the skeleton by dystonic muscle contractions
DESIGN
We propose placing DBS electrodes using microelectrode guidance bilaterally into either the Gpi or STN of medically refractory dystonia patients Physiological studies will be performed and compared with clinical changes to understand the mechanism of action of DBS and underlying pathophysiology of dystonia
OUTCOME MEASURES
Clinical effectiveness of DBS of the Gpi or STN will be measured by the Burke-Fahn-Marsden Scale BFM and monitored over time to determine the effectiveness of DBS and if there is an ideal anatomic stimulation site Electrophysiologic outcome measures will be obtained to determine the underlying pathophysiology of dystonia and the mechanism of action of DBS
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 05-N-0111 | None | None | None |