NCT03131817Completed
Cortical Stimulation to Treat Mood and Behavioral Symptoms in Parkinson's Disease Patients
Cortical Stimulation to Treat Mood and Behavioral Symptoms in Parkinson's
Source: ClinicalTrials.gov · Last updated 21 Nov 2025
Brief summary (registry, in English)
This study will investigate cortical stimulation to treat mood and behavioral symptoms in Parkinson's disease patients.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 5 (actual)
- First submitted
- 28 Sept 2016
- Start date
- 16 Dec 2016
- Primary completion date
- 18 Jun 2024
- Lead sponsor
- Simon J. Little, MBBS, PhD
- Diseases
- Parkinson disease
- NCT number
- NCT03131817
What you commit to
- Study type: Interventional
- Participants enrolled: 5
- From 16 Dec 2016 to the primary completion date, 18 Jun 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- MRI showing focal brain lesions that could indicate a disorder other than idiopathic PD
- Significant cognitive impairment (MoCA\<20).
- History of seizures
- Has an active infection
- Requires diathermy, electroconvulsive therapy (ECT) or transcranial magnetic stimulation (TMS) to treat a chronic condition
Age
- MRI showing cortical atrophy out of proportion to age
Other
- Pregnancy or breast feeding
- Immunocompromised
- Inability to comply with study follow-up visits
- Any personality or mood symptoms that study personnel believe will interfere with study requirements.
Who the study is looking for
- 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:
- depression (BDI\>=13)
- anxiety (BAI \>=7)
- impulsive behavior as indicated by a positive score on the Questionnaire for Impulsive-Compulsive disorders in Parkinson's Disease (QUIP-A) or as determined by clinical interview or informant report
- 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.
Age in the registry: 30 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| UCSF Surgical Movement Disorders Center Coordinator of this site? Confirm its status | San Francisco | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.