Thalamic Deep Brain Stimulation for Secondary Dystonia in... | NCT03078816

NCT03078816

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Detailed Description

Dystonia is a movement disorder seen in both children and adults that is characterized by "sustained or intermittent muscle contractions causing abnormal, often repetitive, movements, postures, or both." Secondary dystonia has evolved to refer to dystonia resulting from damage to the nervous system or degenerative disease processes. While primary dystonia is generally thought to arise from genetic causes, secondary dystonias have a variety of causes including perinatal injuries (cerebral palsy), central nervous system infections, traumatic brain injuries, and many different metabolic, neurodegenerative, and mitochondrial conditions. Secondary dystonia is far more common in pediatric populations than primary dystonia, and far more recalcitrant to standard pharmacologic and surgical treatments including Deep Brain Stimulation. Given that most treatments for dystonia are developed for primary dystonia and then applied to secondary dystonia, it is not surprising that this effectiveness gap exists. Thus, there exists a large unmet need to develop new therapeutics, treatment strategies, and outcome measures for pediatric secondary dystonia.

Deep Brain Stimulation (DBS) is one such therapeutic intervention that has potential to improve secondary dystonia. DBS is a surgical treatment for several different movement disorders that evolved from functional stereotactic neurosurgery techniques initially used to lesion specific deep brain structures. While Essential Tremor and Idiopathic Parkinson's Disease have predictable and consistent response rates to DBS in carefully selected patients, response rates of dystonia have been much more inconsistent. One predictor of success has been the presence of DYT-1 mutation, the most common known genetic cause of primary dystonia. Success rates in DYT-1 dystonia are consistently high with reductions in dystonia typically greater than 80%. However, the results in secondary dystonia have been much more modest and inconsistent. A recent meta-analysis found that on average, dystonia symptoms as measured by common rating scales improve 23% following DBS for dystonic cerebral palsy (the most common cause of secondary dystonia), however there are frequent cases of non-responders. Additionally, there have been very few examination, radiological or laboratory predictors of good response to DBS, except for genetic confirmation of DYT-119. However, across both primary and secondary dystonia, younger age at the time of surgery (less than 21 years old) and shorter duration of symptoms (less than 15 years) have been shown to be the most likely predictive factors for a good postoperative outcome. This has led many to suggest that DBS should be offered earlier in the course of intractable dystonia, prior to the development of permanent complications such as orthopedic contractures. Thus, we are setting an upper age limit of 25 to account for the concern that earlier implantation leads to improved outcomes. The lower age limit of 7 reflects the fact that the current humanitarian exemption for DBS for dystonia currently goes down to age 7. Thus, there exists a need to both improve patient selection as well as application of DBS for secondary dystonia in children.

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
DBS active	Experimental	All participants will be enrolled in DBS placement and active stimulation. The following components will be used: Activa PC Primary Cell Neurostimulator - (Model 37601) Activa RC Rechargeable Neurostimulator - (Model 37612) Activa SC Single Cell Neurostimulator (Models 37602 and 37603) DBS Lead - (Model 3387) DBS Extension - (Models 37085/6) Patient Programmer - (Model 37642) Test Stimulator - (Model 3625) N'Vision Clinician Programmer - (Model 8840) N'Vision Software Application Card - (Model 8870)	Device: Activa PC Primary Cell Neurostimulator - (Model 37601) Device: Activa RC Rechargeable Neurostimulator - (Model 37612) Device: Activa SC Single Cell Neurostimulator (Models 37602/37603) Device: DBS Lead - (Model 3387 Device: DBS Extension - (Models 37085/6) Device: Patient Programmer - (Model 37642) Device: Test Stimulator - (Model 3625) Device: N'Vision Clinician Programmer - (Model 8840) Device: N'Vision Software Application Card - (Model 8870)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Activa PC Primary Cell Neurostimulator - (Model 37601)	Device	Deep Brain Stimulator system will be implanted using standard neurosurgical techniques. The device will deliver constant stimulation to the thalamus using settings programmed by study team.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change From Baseline in Burke-Fahn-Marsden Dystonia Rating Scale	Rating scale that measures movement and disability related to dystonia, range 0-120 motor, 0-30 disability , higher number indicates more severe dystonia Change from Baseline in Burke-Fahn-Marsden Dystonia Rating Scale	Change from baseline to 12 months postoperatively
Percent Change in Pediatric Quality of Life Inventory (PedsQL)	Quality of life measure, scored 0-100, larger scores indicate greater hinderance (ie. lower quality of life)	baseline to 12 months postoperatively
Change in Barry Albright Dystonia Rating Scale	Severity scale for secondary dystonia, range 0-32, higher scores indicates more severe dystonia	Change from baseline to 12 months postoperatively
Change in Blinded Burke-Fahn-Marsden Dystonia Rating Scale	Rating scale that measures movement and disability related to dystonia, range 0-120 motor, 0-30 disability , higher number indicates more severe dystonia. These ratings were carried out retroactively by a neurologist who was unfamiliar with the four study participants and who had no knowledge of their unblinded scores.	change from baseline to 12 months postoperatively

Secondary Outcomes

Measure	Description	Time Frame
Change in Modified Ashworth Scale - Upper Limbs	Measure of spasticity, range 0-32, higher values indicate more spasticity	Change from baseline to 12 months postoperatively
Change in Diadochokinetic Syllable Rates

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Marta San Luciano Palenzuela, MD	University of California, San Francisco	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
University of California San Francisco Hospital		San Francisco	California	94158	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
23893449	Background	Mink JW. Special concerns in defining, studying, and treating dystonia in children. Mov Disord. 2013 Jun 15;28(7):921-5. doi: 10.1002/mds.25548.
21887135	Background	Sironi VA. Origin and evolution of deep brain stimulation. Front Integr Neurosci. 2011 Aug 18;5:42. doi: 10.3389/fnint.2011.00042. eCollection 2011.

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	DBS Active	Participants will have DBS placement and active stimulation.The following components will be used: Activa PC Primary Cell Neurostimulator(Model 37601) Activa RC Rechargeable Neurostimulator(Model 37612) Activa SC Single Cell Neurostimulator(Models 37602 and 37603) DBS Lead(Model 3387) DBS Extension(Models 37085/6) Patient Programmer(Model 37642) Test Stimulator(Model 3625) N'Vision Clinician Programmer(Model 8840) N'Vision Software Application Card(Model 8870) Activa PC Primary Cell Neurostimulator(Model 37601): Deep Brain Stimulator system will be implanted using standard neurosurgical techniques. The device will deliver constant stimulation to the thalamus using settings programmed by study team. Activa RC Rechargeable Neurostimulator - (Model 37612): Deep Brain Stimulator system will be implanted using standard neurosurgical techniques.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Uploaded Document Information

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Mar 3, 2017

Derived Section

Miscellaneous Info Module

Submission Tracking

Condition Browse Module

Intervention Browse Module

No data available

No data is available for this block.

Masking Info

Articulation, range (min 6- no upper limit), longer times indicate less articulation/more difficulty with speech

Type of Units Analyzed

Arm/Group Information

ID	Title	Description
BG000	DBS Active	All participants will be enrolled in DBS placement and active stimulation. The following components will be used: Activa PC Primary Cell Neurostimulator - (Model 37601) Activa RC Rechargeable Neurostimulator - (Model 37612) Activa SC Single Cell Neurostimulator (Models 37602 and 37603) DBS Lead - (Model 3387) DBS Extension - (Models 37085/6) Patient Programmer - (Model 37642) Test Stimulator - (Model 3625) N'Vision Clinician Programmer - (Model 8840) N'Vision Software Application Card - (Model 8870) Activa PC Primary Cell Neurostimulator - (Model 37601): Deep Brain Stimulator system will be implanted using standard neurosurgical techniques. The device will deliver constant stimulation to the thalamus using settings programmed by study team. Activa RC Rechargeable Neurostimulator - (Model 37612): Deep Brain Stimulator system will be implanted using standard neurosurgical techniques.

Units	Counts
Participants	BG0004

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Categorical

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
<=18 years	BG0003
Between 18 and 65 years	BG0001
>=65 years	BG000

Age, Continuous

Mean

Full Range

years

Title

Denominators

Categories

Title	Measurements
	BG00014.5(9 to 19)

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG0002
Male	BG0002

Race/Ethnicity, Customized

Number

participants

Title

Denominators

Categories

White/ not Hispanic

Title	Measurements
	BG0002

White/ hispanic

Title	Measurements
	BG000

Region of Enrollment

Number

participants

Title

Denominators

Categories

United States

Title	Measurements
	BG0004

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Change From Baseline in Burke-Fahn-Marsden Dystonia Rating Scale

Rating scale that measures movement and disability related to dystonia, range 0-120 motor, 0-30 disability , higher number indicates more severe dystonia

Change from Baseline in Burke-Fahn-Marsden Dystonia Rating Scale

Posted

Mean

Standard Error

change in points on a scale

Change from baseline to 12 months postoperatively

ID	Title	Description
OG000	DBS Active	Participants will have DBS placement and active stimulation.The following components will be used: Activa PC Primary Cell Neurostimulator(Model 37601) Activa RC Rechargeable Neurostimulator(Model 37612) Activa SC Single Cell Neurostimulator(Models 37602 and 37603) DBS Lead(Model 3387) DBS Extension(Models 37085/6) Patient Programmer(Model 37642) Test Stimulator(Model 3625) N'Vision Clinician Programmer(Model 8840) N'Vision Software Application Card(Model 8870) Activa PC Primary Cell Neurostimulator(Model 37601): Deep Brain Stimulator system will be implanted using standard neurosurgical techniques. The device will deliver constant stimulation to the thalamus using settings programmed by study team. Activa RC Rechargeable Neurostimulator - (Model 37612): Deep Brain Stimulator system will be implanted using standard neurosurgical techniques.

Units	Counts
Participants	OG0004

Title

Denominators

Categories

Title	Measurements
	OG00014.7± 11.8

Primary

Percent Change in Pediatric Quality of Life Inventory (PedsQL)

Quality of life measure, scored 0-100, larger scores indicate greater hinderance (ie. lower quality of life)

Posted

Mean

Full Range

percent change

baseline to 12 months postoperatively

ID	Title	Description
OG000	DBS Active	Participants will have DBS placement and active stimulation.The following components will be used: Activa PC Primary Cell Neurostimulator(Model 37601) Activa RC Rechargeable Neurostimulator(Model 37612) Activa SC Single Cell Neurostimulator(Models 37602 and 37603) DBS Lead(Model 3387) DBS Extension(Models 37085/6) Patient Programmer(Model 37642) Test Stimulator(Model 3625) N'Vision Clinician Programmer(Model 8840) N'Vision Software Application Card(Model 8870) Activa PC Primary Cell Neurostimulator(Model 37601): Deep Brain Stimulator system will be implanted using standard neurosurgical techniques. The device will deliver constant stimulation to the thalamus using settings programmed by study team. Activa RC Rechargeable Neurostimulator - (Model 37612): Deep Brain Stimulator system will be implanted using standard neurosurgical techniques.

Units	Counts
Participants	OG000

Primary

Change in Barry Albright Dystonia Rating Scale

Severity scale for secondary dystonia, range 0-32, higher scores indicates more severe dystonia

Posted

Mean

Standard Error

average change of points on a scale

Change from baseline to 12 months postoperatively

ID	Title	Description
OG000	DBS Active	Participants will have DBS placement and active stimulation.The following components will be used: Activa PC Primary Cell Neurostimulator(Model 37601) Activa RC Rechargeable Neurostimulator(Model 37612) Activa SC Single Cell Neurostimulator(Models 37602 and 37603) DBS Lead(Model 3387) DBS Extension(Models 37085/6) Patient Programmer(Model 37642) Test Stimulator(Model 3625) N'Vision Clinician Programmer(Model 8840) N'Vision Software Application Card(Model 8870) Activa PC Primary Cell Neurostimulator(Model 37601): Deep Brain Stimulator system will be implanted using standard neurosurgical techniques. The device will deliver constant stimulation to the thalamus using settings programmed by study team. Activa RC Rechargeable Neurostimulator - (Model 37612): Deep Brain Stimulator system will be implanted using standard neurosurgical techniques.

Units	Counts
Participants	OG000

Primary

Change in Blinded Burke-Fahn-Marsden Dystonia Rating Scale

Rating scale that measures movement and disability related to dystonia, range 0-120 motor, 0-30 disability , higher number indicates more severe dystonia. These ratings were carried out retroactively by a neurologist who was unfamiliar with the four study participants and who had no knowledge of their unblinded scores.

Posted

Mean

Standard Error

change in points on a scale

change from baseline to 12 months postoperatively

ID	Title	Description
OG000	DBS Active	Participants will have DBS placement and active stimulation.The following components will be used: Activa PC Primary Cell Neurostimulator(Model 37601) Activa RC Rechargeable Neurostimulator(Model 37612) Activa SC Single Cell Neurostimulator(Models 37602 and 37603) DBS Lead(Model 3387) DBS Extension(Models 37085/6) Patient Programmer(Model 37642) Test Stimulator(Model 3625) N'Vision Clinician Programmer(Model 8840) N'Vision Software Application Card(Model 8870) Activa PC Primary Cell Neurostimulator(Model 37601): Deep Brain Stimulator system will be implanted using standard neurosurgical techniques. The device will deliver constant stimulation to the thalamus using settings programmed by study team. Activa RC Rechargeable Neurostimulator - (Model 37612): Deep Brain Stimulator system will be implanted using standard neurosurgical techniques.

Units	Counts
Participants

Secondary

Change in Modified Ashworth Scale - Upper Limbs

Measure of spasticity, range 0-32, higher values indicate more spasticity

Posted

Mean

Full Range

percentage change in points on a scale

Change from baseline to 12 months postoperatively

ID	Title	Description
OG000	DBS Active	Participants will have DBS placement and active stimulation.The following components will be used: Activa PC Primary Cell Neurostimulator(Model 37601) Activa RC Rechargeable Neurostimulator(Model 37612) Activa SC Single Cell Neurostimulator(Models 37602 and 37603) DBS Lead(Model 3387) DBS Extension(Models 37085/6) Patient Programmer(Model 37642) Test Stimulator(Model 3625) N'Vision Clinician Programmer(Model 8840) N'Vision Software Application Card(Model 8870) Activa PC Primary Cell Neurostimulator(Model 37601): Deep Brain Stimulator system will be implanted using standard neurosurgical techniques. The device will deliver constant stimulation to the thalamus using settings programmed by study team. Activa RC Rechargeable Neurostimulator - (Model 37612): Deep Brain Stimulator system will be implanted using standard neurosurgical techniques.

Units	Counts
Participants	OG000

Secondary

Change in Diadochokinetic Syllable Rates

Articulation, range (min 6- no upper limit), longer times indicate less articulation/more difficulty with speech

Syllable rates collected from 2 out of the 4 participants as reported here.

Posted

Mean

Standard Deviation

change in number utterances per 15 sec

Change from baseline to 12 months postoperatively

ID	Title	Description
OG000	DBS Active	Participants will have DBS placement and active stimulation.The following components will be used: Activa PC Primary Cell Neurostimulator(Model 37601) Activa RC Rechargeable Neurostimulator(Model 37612) Activa SC Single Cell Neurostimulator(Models 37602 and 37603) DBS Lead(Model 3387) DBS Extension(Models 37085/6) Patient Programmer(Model 37642) Test Stimulator(Model 3625) N'Vision Clinician Programmer(Model 8840) N'Vision Software Application Card(Model 8870) Activa PC Primary Cell Neurostimulator(Model 37601): Deep Brain Stimulator system will be implanted using standard neurosurgical techniques. The device will deliver constant stimulation to the thalamus using settings programmed by study team. Activa RC Rechargeable Neurostimulator - (Model 37612): Deep Brain Stimulator system will be implanted using standard neurosurgical techniques.

Units	Counts
Participants

Secondary

Children's Memory Scale

Will include the following subtests: Memory for Faces, Dot Locations, and Digit Span

The Children's Memory Scale was not administered.

Posted

Change from baseline to 12 months postoperatively

ID	Title	Description
OG000	DBS Active	Participants will have DBS placement and active stimulation.The following components will be used: Activa PC Primary Cell Neurostimulator(Model 37601) Activa RC Rechargeable Neurostimulator(Model 37612) Activa SC Single Cell Neurostimulator(Models 37602 and 37603) DBS Lead(Model 3387) DBS Extension(Models 37085/6) Patient Programmer(Model 37642) Test Stimulator(Model 3625) N'Vision Clinician Programmer(Model 8840) N'Vision Software Application Card(Model 8870) Activa PC Primary Cell Neurostimulator(Model 37601): Deep Brain Stimulator system will be implanted using standard neurosurgical techniques. The device will deliver constant stimulation to the thalamus using settings programmed by study team. Activa RC Rechargeable Neurostimulator - (Model 37612): Deep Brain Stimulator system will be implanted using standard neurosurgical techniques.

Units	Counts
Participants	OG000

Secondary

Change in Behavioral Assessment System, 3rd Edition: Self Report of Personality

Mood and behavior assessment, main use as a screening tool for depression.

Behavioral Assessment System was able to be completed by only one of the four participants. Categorical description of "atypicality" is all that was reported for the baseline and 12 month follow-up on this participant (participant 4), and no quantitative score was recorded.

Posted

Change from baseline to 12 months postoperatively

ID	Title	Description
OG000	DBS Active	Participants will have DBS placement and active stimulation.The following components will be used: Activa PC Primary Cell Neurostimulator(Model 37601) Activa RC Rechargeable Neurostimulator(Model 37612) Activa SC Single Cell Neurostimulator(Models 37602 and 37603) DBS Lead(Model 3387) DBS Extension(Models 37085/6) Patient Programmer(Model 37642) Test Stimulator(Model 3625) N'Vision Clinician Programmer(Model 8840) N'Vision Software Application Card(Model 8870) Activa PC Primary Cell Neurostimulator(Model 37601): Deep Brain Stimulator system will be implanted using standard neurosurgical techniques. The device will deliver constant stimulation to the thalamus using settings programmed by study team. Activa RC Rechargeable Neurostimulator - (Model 37612): Deep Brain Stimulator system will be implanted using standard neurosurgical techniques.

Units	Counts

Secondary

Change in Modified Ashworth Scale Spasticity Ratings - Lower Limbs

This scale is used to measure spasticity, which is a velocity-dependent increase in muscle stretch reflexes associated with increased muscle tone as a component of upper motor neuron syndrome. It is scored 0-4 with higher scores indicating greater severity.

Posted

Mean

Full Range

percentage change in points on a scale

Change from baseline to 12 months postoperatively

ID	Title	Description
OG000	DBS Active	Participants will have DBS placement and active stimulation.The following components will be used: Activa PC Primary Cell Neurostimulator(Model 37601) Activa RC Rechargeable Neurostimulator(Model 37612) Activa SC Single Cell Neurostimulator(Models 37602 and 37603) DBS Lead(Model 3387) DBS Extension(Models 37085/6) Patient Programmer(Model 37642) Test Stimulator(Model 3625) N'Vision Clinician Programmer(Model 8840) N'Vision Software Application Card(Model 8870) Activa PC Primary Cell Neurostimulator(Model 37601): Deep Brain Stimulator system will be implanted using standard neurosurgical techniques. The device will deliver constant stimulation to the thalamus using settings programmed by study team. Activa RC Rechargeable Neurostimulator - (Model 37612): Deep Brain Stimulator system will be implanted using standard neurosurgical techniques.

Units	Counts
Participants

Secondary

Change in Kaufman Brief Intelligence Test - Second Addition

Kaufman Brief Intelligence Test Second Edition (KBIT-2) is a brief measure of verbal and nonverbal intelligence used with individuals ages 4 through 90 years, raw scores 0 - unlimited, with higher scores indicating higher ability.

The Kaufman Brief Intelligence Test was only administered to 3 of the 4 participants.

Posted

Mean

Standard Deviation

change BL- 12 mo. raw score on a scale

baseline to 12 months postoperatively

ID	Title	Description
OG000	DBS Active	Participants will have DBS placement and active stimulation.The following components will be used: Activa PC Primary Cell Neurostimulator(Model 37601) Activa RC Rechargeable Neurostimulator(Model 37612) Activa SC Single Cell Neurostimulator(Models 37602 and 37603) DBS Lead(Model 3387) DBS Extension(Models 37085/6) Patient Programmer(Model 37642) Test Stimulator(Model 3625) N'Vision Clinician Programmer(Model 8840) N'Vision Software Application Card(Model 8870) Activa PC Primary Cell Neurostimulator(Model 37601): Deep Brain Stimulator system will be implanted using standard neurosurgical techniques. The device will deliver constant stimulation to the thalamus using settings programmed by study team. Activa RC Rechargeable Neurostimulator - (Model 37612): Deep Brain Stimulator system will be implanted using standard neurosurgical techniques.

Units	Counts

Secondary

Change in Burke-Fahn-Marsden Dystonia Disability Subscale

This scale is a measurement of quality of life related to dystonia, with lower scores indicating greater quality of life and high scores indicating more hinderance. It is scored 0-100.

Posted

Mean

Full Range

percentage change in score on a scale

baseline to 12 months postoperatively

ID	Title	Description
OG000	DBS Active	Participants will have DBS placement and active stimulation.The following components will be used: Activa PC Primary Cell Neurostimulator(Model 37601) Activa RC Rechargeable Neurostimulator(Model 37612) Activa SC Single Cell Neurostimulator(Models 37602 and 37603) DBS Lead(Model 3387) DBS Extension(Models 37085/6) Patient Programmer(Model 37642) Test Stimulator(Model 3625) N'Vision Clinician Programmer(Model 8840) N'Vision Software Application Card(Model 8870) Activa PC Primary Cell Neurostimulator(Model 37601): Deep Brain Stimulator system will be implanted using standard neurosurgical techniques. The device will deliver constant stimulation to the thalamus using settings programmed by study team. Activa RC Rechargeable Neurostimulator - (Model 37612): Deep Brain Stimulator system will be implanted using standard neurosurgical techniques.

Units	Counts
Participants

Secondary

Change in Modified Unified Parkinson's Disease Rating Scale - Second Edition

This scale is a measurement of quality of life related to dystonia, with lower scores indicating greater quality of life and high scores indicating more hinderance. It is scored 0-199

Outcome data for this scale is only available for two of the four participants because the scale was not administered during the 12 month follow up visit for these two patients.

Posted

Mean

Full Range

percentage change in points on a scale

baseline to 12 months posoperatively

ID	Title	Description
OG000	DBS Active	Participants will have DBS placement and active stimulation.The following components will be used: Activa PC Primary Cell Neurostimulator(Model 37601) Activa RC Rechargeable Neurostimulator(Model 37612) Activa SC Single Cell Neurostimulator(Models 37602 and 37603) DBS Lead(Model 3387) DBS Extension(Models 37085/6) Patient Programmer(Model 37642) Test Stimulator(Model 3625) N'Vision Clinician Programmer(Model 8840) N'Vision Software Application Card(Model 8870) Activa PC Primary Cell Neurostimulator(Model 37601): Deep Brain Stimulator system will be implanted using standard neurosurgical techniques. The device will deliver constant stimulation to the thalamus using settings programmed by study team. Activa RC Rechargeable Neurostimulator - (Model 37612): Deep Brain Stimulator system will be implanted using standard neurosurgical techniques.

Units

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	DBS Active	All participants will be enrolled in DBS placement and active stimulation. The following components will be used: Activa PC Primary Cell Neurostimulator - (Model 37601) Activa RC Rechargeable Neurostimulator - (Model 37612) Activa SC Single Cell Neurostimulator (Models 37602 and 37603) DBS Lead - (Model 3387) DBS Extension - (Models 37085/6) Patient Programmer - (Model 37642) Test Stimulator - (Model 3625) N'Vision Clinician Programmer - (Model 8840) N'Vision Software Application Card - (Model 8870) Activa PC Primary Cell Neurostimulator - (Model 37601): Deep Brain Stimulator system will be implanted using standard neurosurgical techniques. The device will deliver constant stimulation to the thalamus using settings programmed by study team. Activa RC Rechargeable Neurostimulator - (Model 37612): Deep Brain Stimulator system will be implanted using standard neurosurgical techniques.	0	4	0	4	4	4

Other Adverse Events

Term	Organ System	Assessment Type	Statistical Information
Diarrhea	Gastrointestinal disorders	Non-systematic Assessment	EG0001 events1 affected4 at risk
teeth hurt	General disorders	Non-systematic Assessment	EG0001 events1 affected4 at risk
worsening hand movements	General disorders	Non-systematic Assessment	EG0001 affected4 at risk
drooling in sleep	General disorders	Non-systematic Assessment	EG0002 events1 affected4 at risk
full body jerks	General disorders	Non-systematic Assessment	EG0001 events1 affected4 at risk
fever or flu	General disorders	Non-systematic Assessment	EG0001 events1 affected4 at risk
attitude	General disorders	Non-systematic Assessment	EG0001 events1 affected4 at risk
viral illness	General disorders	Non-systematic Assessment	EG0001 events1 affected4 at risk
Weight Gain	General disorders	Non-systematic Assessment	EG0001 events1 affected4 at risk
stool incontinence	General disorders	Non-systematic Assessment	EG0001 events1 affected4 at risk

First MCP Posted Date

ID	Term
D004421	Dystonia

ID	Term
D020820	Dyskinesias
D009461	Neurologic Manifestations
D009422	Nervous System Diseases
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms