Closed Loop Deep Brain Stimulation in Parkinson’s Disease and Dystonia (Activa RC+S)

Parkinson’s Disease:

1. Ability to give informed consent for the study

2. Movement disorder symptoms that are sufficiently severe, in spite of best medical
therapy, to warrant surgical implantation of deep brain stimulators according to
standard clinical criteria

3. Patient has requested surgical intervention with deep brain stimulation for their
disorder

4. No MR abnormalities that suggest an alternative diagnosis or contraindicate surgery

5. Absence of significant cognitive impairment (score of 20 or greater on the Montreal
Cognitive Assessment (MoCA),

6. Signed informed consent

7. Ability to comply with study follow-up visits for brain recording, testing of adaptive
stimulation, and clinical assessment.

8. Age 21-75 (for STN patients, minimum age is 25)

9. Diagnosis of idiopathic PD with duration of motor symptoms for 4 years or greater

10. Patient has undergone appropriate therapy with oral medications with inadequate relief
as determined by a movement disorders neurologist, and has had stable doses of
antiparkinsonian medications for 30 days prior to baseline assessment.

11. UPDRS-III score off medication between 20 and 80 and an improvement of at least 30% in
the baseline UPDRS-III on medication score, compared to the baseline off-medication
score, and motor fluctuations with at least 2 hours per day of on time without
dyskinesia or with non-bothersome dyskinesia.

OR Patients with tremor-dominant PD (a tremor score of at least 2 on a UPDRS-III sub-score
for tremor), treatment resistant, with significant functional disability despite maximal
medical management

Dystonia:

1. Ability to give informed consent for the study

2. Movement disorder symptoms that are sufficiently severe, in spite of best medical
therapy, to warrant surgical implantation of deep brain stimulators according to
standard clinical criteria

3. Patient has requested surgical intervention with deep brain stimulation for their
disorder

4. No MR abnormalities that suggest an alternative diagnosis or contraindicate surgery

5. Absence of significant cognitive impairment (score of 20 or greater on the Montreal
Cognitive Assessment (MoCA)

6. Signed informed consent

7. Ability to comply with study follow-up visits for brain recording, testing of adaptive
stimulation, and clinical assessment.

8. Age 21-75

9. Diagnosis of Isolated dystonia, which may be focal cervical, segmental craniocervical,
or generalized forms.

10. Stable doses of anti-dystonia medications (such as trihexyphenydil, Baclofen, or
clonazepam) for at least 30 days prior to baseline assessment

11. For dystonia patients with craniofacial and cervical involvement, prior treatment with
botulinum toxin with failure to adequately control dystonia symptoms.

Exclusion Criteria

Parkinson’s Disease:

1. Coagulopathy, anticoagulant medications, uncontrolled hypertension, history of
seizures, heart disease, or other medical conditions considered to place the patient
at elevated risk for surgical complications

2. Evidence of a psychogenic movement disorder: Motor symptoms that remit with suggestion
or “while unobserved”, symptoms that are inconsistent over time or incongruent with
clinical condition, plus other manifestation such as “false” signs, multiple
somatizations, or obvious psychiatric disturbance.

3. Pregnancy: all women of child bearing potential will have a negative urine pregnancy
test prior to undergoing their surgical procedure.

4. Significant untreated depression (BDI-II score >20) History of suicidal attempt or
active suicidal ideation (Yes to #2-5 on C-SSRS)

5. Any personality or mood symptoms that study personnel believe will interfere with
study requirements.

6. Subjects who require ECT, rTMS or diathermy

7. Implanted stimulation systems such as; cochlear implant, pacemaker, defibrillator,
neurostimulator or metallic implant

8. Previous cranial surgery

9. Drug or alcohol abuse

10. Meets criteria for Parkinson’s disease with mild cognitive impairment (PD-MCI). These
criteria are: performance of more than two standard deviations below appropriate
norms, for tests from two or more of these five cognitive domains: attention,
executive function, language, memory, and visuospatial tests.

Dystonia:

1. Coagulopathy, anticoagulant medications, uncontrolled hypertension, history of
seizures, heart disease, or other medical conditions considered to place the patient
at elevated risk for surgical complications

2. Evidence of a psychogenic movement disorder: Motor symptoms that remit with suggestion
or “while unobserved”, symptoms that are inconsistent over time or incongruent with
clinical condition, plus other manifestation such as “false” signs, multiple
somatizations, or obvious psychiatric disturbance.

3. Pregnancy: all women of child bearing potential will have a negative urine pregnancy
test prior to undergoing their surgical procedure.

4. Significant untreated depression (BDI-II score >20) History of suicidal attempt or
active suicidal ideation (Yes to #2-5 on C-SSRS)

5. Any personality or mood symptoms that study personnel believe will interfere with
study requirements.

6. Subjects who require ECT, rTMS or diathermy

7. Implanted stimulation systems such as; cochlear implant, pacemaker, defibrillator,
neurostimulator or metallic implant

8. Previous cranial surgery

9. Drug or alcohol abuse