Tryptophan depletion in Parkinson*s disease patients treated with deep brain stimulation of the subthalamic nucleus: effects on mood and motor functions.
- Conditions
- Parkinson's disease1002803710027946
- Registration Number
- NL-OMON41322
- Lead Sponsor
- Medisch Universitair Ziekenhuis Maastricht
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 30
Subjects must be mentally competent (*wilsbekwaam*)
Subjects must have undergone STN DBS surgery for Parkinson's disease symptomatology ;Age, duration and severity of disease, duration of DBS implantation do not play a role in the selection process.
Head injury
Stroke
Neurological disorders other than PD
Psychoactive medication: antidepressants and antipsychotics (a stable dose of benzodiazepines will be allowed).
Clinically relevant cognitive decline, operationalized as an Mini Mental State Examination score <24
Current psychiatric symptomatology, operationalized as a Hamilton Depression scale score >16 or a score >2 on any of the MDS-UPDRS section I items.
Current malignancy or infection;Age, duration and severity of disease, duration of DBS implantation do not play a role in the selection process.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Our primary outcome measures are changes in mood scales (depression,<br /><br>(hypo)mania). </p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary outcome measures are<br /><br>1) the motor scores as assessed through the Unified Parkinson Disease Rating<br /><br>Scale and the motor component of the reaction time task;<br /><br>2) impulsivity as assessed through the impulsivity component of the reaction<br /><br>time task.<br /><br>3) emotional responsiveness as assessed through the emotional responsiveness<br /><br>task.</p><br>