Cortical Stimulation to Treat Mood and Behavioral Symptoms in Parkinson’s
Sponsor:
Brief Summary:
Parkinson’s disease patients.
Criteria
– Ability to give informed consent for the study
– Age 30-75
– Diagnosis of Parkinson’s disease by a movement disorders specialist
– Movement disorder symptoms that are sufficiently severe, in the setting of best
medical therapy, to warrant surgical implantation of deep brain stimulators according
to standard clinical criteria
– 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.
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 OR Patients intolerant to medication causing significant functional
disability
– Have one or several mild to moderate mood or impulsive behavior as defined by:
1. depression (BDI>=13)
2. anxiety (BAI >=7)
3. impulsive behavior as indicated by a positive score on the QUIP-A (Questionnaire
for Impulsive-Compulsive disorders in Parkinson’s Disease) or as determined by
clinical interview or informant report
4. Mood or behavior symptom fluctuations corresponding to minimum 30% improvement in
non-motor symptoms when comparing visual analogue scales (VAS) scores in the on
versus off medication state
– Stable doses of anti-Parkinsonian medications for at least 30 days prior to their
baseline assessment.
Exclusion Criteria:
– Pregnancy or breast feeding
– MRI showing cortical atrophy out of proportion to age
– MRI showing focal brain lesions that could indicate a disorder other than idiopathic
PD
– Major comorbidity increasing the risk of surgery (prior stroke, severe hypertension,
severe diabetes, or need for chronic anticoagulation other than aspirin)
– Any prior intracranial surgery except DBS surgery
– Significant cognitive impairment (MoCA<20). - History of seizures - Immunocompromised - Has an active infection - Requires diathermy, electroconvulsive therapy (ECT) or transcranial magnetic stimulation (TMS) to treat a chronic condition - Inability to comply with study follow-up visits - Any personality or mood symptoms that study personnel believe will interfere with study requirements.
Locations
- UCSF Surgical Movement Disorders Center, San Francisco, California, United States, 94115