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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
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

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
UCSF Surgical Movement Disorders Center
Coordinator of this site? Confirm its status
San FranciscoUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.