Please select the eligibility criteria that correspond to the clinical trial below.
Title: The Human Thalamocortical Network in Tourette Syndrome
Brief Summary: The purpose of this study is to evaluate the effectiveness and safety of deep brain stimulation (DBS) as a possible new treatment for Tourette Syndrome (TS).

This investigation will (1) test the hypothesis that centromedian (CM) continuous brain stimulation will be an effective, safe method for the treatment of tics in medication refractory TS, (2) will define the intra-operative and post-operative physiological changes, and (3) will test the hypothesis that responsive brain stimulation (RBS) will provide an alternative to chronic DBS in TS.


Options:
A: Inclusion Criteria:

* Tourette's syndrome (DSM IV)
* inducing a disability in the social and personal life
* No improvement with medical treatment
* Severe self suffering

Exclusion Criteria:

* Cognitive impairment (MMS \< 24)
* Depression
B: Inclusion Criteria:

* Patients must have a clinical diagnosis of probable idiopathic PD.
* Demonstrated response to dopaminergic therapy, defined as demonstrating at least 30% improvement in parkinsonian motor signs, based upon the UPDRS motor examination subscore, following the administration of their dopamine agonist (DA) drug(s) during the screening neurological examination.
* Hoehn and Yahr (H\&Y) stage II when OFF medication.
* No contraindications to surgery.
* Age between 50 and 75 years old.
* Available for follow-up for four years.
* Informed Consent: The subject understands the risks, benefits, and alternatives to the study procedures and participation in the study.
* MRI within normal range for age.
* Levodopa or dopamine agonist therapy for greater than six months but less than or equal to four years.

Exclusion Criteria:

* Evidence of an alternative diagnosis or secondary parkinsonism, as suggested by features unusual early in the clinical course: Prominent postural instability, freezing phenomena, or hallucinations unrelated to medications in the first 3 years after symptom onset; dementia preceding motor symptoms; supranuclear gaze palsy (other than restriction of upward gaze) or slowing of vertical saccades in the first year; severe, symptomatic dysautonomia unrelated to medications; documentation of a condition known to produce parkinsonism and plausibly connected to the subject's symptoms (such as suitably located focal brain lesions or neuroleptic use within the past 6 months)
* Uncontrolled medical condition or clinically significant medical disease that would increase the risk of developing pre- or postoperative complications (e.g., significant cardiac or pulmonary disease, uncontrolled hypertension).
* Evidence of dementia
* Major psychiatric disorder
* Previous brain operation or injury.
* Active participation in another clinical trial for the treatment of PD.
* Patients who have demand cardiac pacemakers or implantable cardioverter defibrillators (ICD's).
* Patients who have medical conditions that require repeat MRI scans or diathermy treatments.
* Evidence of existing dyskinesias or motor fluctuations.
C: Inclusion Criteria:

* Must be 21+ years of age
* Diagnosis of Tourette Syndrome (TS) in accordance to the Diagnostic and Statistical Manual of Mental DIsorders (DSM-V) criteria
* Yale Global Tic Severity Scale (YGTSS) must be ≥35/50 for at least 12 months; Motor Tic subscore must be ≥15
* TS must be causing incapacitation with severe distress, self-injurious behavior, and/or quality of life disruption
* TS must be medication refractory. Criteria to determine if medication refractory is the exact criteria stated by Mink et. al TSA DBS Guidelines published in 2006: Subjects must have been treated by a psychiatrist or neurologist experienced in TS with therapeutic doses of either 1-4 mg/day of haloperidol or 2-8 mg/day of pimozide, risperidone (1-3 mg/day), and aripiprazole (2.5-5 mg/day). Must be at minimum a single trial with an alpha-2 adrenergic agonist (0.1-0.3 mg/day)
* Clinically relevant depression must be pharmacologically treated and deemed stable
* Must have been stabilized for 1 month on TS medication without a dose change prior to surgical intervention. If medication trials resulted in discontinuation of TS medications, the subject must be stabilized for 3 months off TS medicines
* Must be willing to keep TS related medications stable and unchanged throughout the trial
* Must have been offered habit reversal therapy/cognitive behavioral intervention therapy (HRT) if subject did not have it prior to enrollment. (Subjects not required to participate in HRT but it will be highly encouraged, and must be completed prior to start of this study's protocol. Those who improve significantly will be excluded from receiving DBS surgery)
* If tic is focal or addressable by botulinum toxin treatment, the study neurologist will offer to administer a trial of botulinum toxin prior to consideration of surgical therapy. (If the subject chooses not to have the treatment, they cannot participate in the study. If the patient responds satisfactorily and their quality of life significantly improves, they will be excluded)

Exclusion Criteria:

* Any previous neurological intervention including DBS or ablative brain lesions, any metal in the head, and any type of implanted stimulator
* Untreated or unstable anxiety, depression, bipolar disorder, or other Axis I psychiatric disorder
* Presence of psychotic features
* Significant psychosocial factors that can cause increased risk
* The presence of only simple motor tics, a movement disorder other than TS, or medication related movement disorders from TS medications
* Severe medical co-morbidity including cardiovascular disorder, lung disorder, kidney disease, chronic neurological disease, hematological disease, or frailty that impacts tolerability of the surgery as judged by the screening physicians
* Abnormal brain magnetic resonance imaging (MRI) scan, including severe atrophy, hydrocephalus, stroke, structural lesions, demyelinating lesions, or infectious lesions that would potentially confound the outcome or safety of the surgery as judged by the study neurosurgeon
* Dementia or cognitive dysfunction that will place the subject at risk for worsening cognition, and/or may impact the ability to cooperate with tasks involved in the study
* Any attempt or intent of suicide in the last 6 months
* Significant substance abuse or dependence within the last 6 months
* Multiple failed medication treatments of inadequate dose or duration
* History of noncompliance with previous medical and psychosocial treatment efforts
* Severe head banging tics
* Women of child-bearing potential who are pregnant or planning pregnancy (urine pregnancy test required)
* Positive urine drug screen for illicit substances (urine drug screen required)
* History of multiple surgical procedures with poor outcomes
* Unexplained gaps in medical history
* Pending lawsuits or other legal action
D: Inclusion Criteria:

1. The participant must be adult with stable Tourette syndrome.
2. The participant must have a chronic and severe tic disorder with severe functional impairment, with a Yale Tourette Severity Scale score of at least 35/55 for at least 12 months prior to surgery.
3. The participant must have failed conventional medical treatment at therapeutic doses of three classes of medication.
4. The participant must not be suitable for behavioural intervention or that this intervention is inappropriate or unsuccessful.
5. The participant must have been on stable and optimised treatment of co-morbid conditions for at least 6 months.
6. The participant must be actively involved with and compliant with any psychosocial interventions.
7. The patient must be compliant with treatment plans.

Exclusion Criteria:

1. The tic disorder is attributable to any other condition.
2. Any other medical or psychiatric disorders that substantially increase the risk of a failed procedure or that would significantly impede recovery.
3. Psychosocial factors which might impede operative and post-operative care and research participation.
4. Coagulation problems
5. Other disease compromising life expectancy
6. Patient likely to benefit from psychological intervention
7. Patient unwilling to co-operate with post operative assessment and care
8. Pregnancy.
9. Participant under 20 years old.

Answer: C