Tryptophan Depletion in PD Patients Treated With STN DBS

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02632279
• Date of registration: 26/11/2015
• Prospective Registration: No
• Primary sponsor: Maastricht University Medical Center
• Public title: Tryptophan Depletion in PD Patients Treated With STN DBS
• Scientific title: Tryptophan Depletion in Parkinson's Disease Patients Treated With Deep Brain Stimulation of the Subthalamic Nucleus: Effects on Mood and Motor Functions
• Date of first enrolment: November 2015
• Target sample size: 7
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT02632279
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Investigator, Outcomes Assessor).
• Phase: N/A

Countries of recruitment

Netherlands

Contacts

• Name: Yasin Temel, MD, PhD
• Affiliation: Maastricht University Medical Center

Key inclusion & exclusion criteria

Inclusion Criteria:

- subjects must be mentally competent

- subjects must have undergone STN DBS surgery for PD symptomatology

Exclusion Criteria:

- head injury

- stroke

- currentl malignancy or infection

- neurological disorders other than PD

- psychoactive medication: specifically antidepressants and antipsychotics ( a stable
dose of benzodiazepines will be allowed)

- clinically relevant cognitive decline, operationalized as a MMSE score < 24

- current psychiatric syptomatology, operationalized as a Hamilton Depression scale
score > 16 or a score >2 on one of the MDS-UPDRS section I, items 1-6



Age minimum: N/A
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Parkinson's Disease

Intervention(s)

Device: Stimulator ON

Dietary Supplement: Tryptophan (TRP) depletion

Dietary Supplement: Placebo

Device: Stimulator OFF

Primary Outcome(s)

Mood [Time Frame: There will be 6 measurements spread over 2 testing days with a wash-out period of min. 1 weak. baseline measure, 3.5 hours after intake of the amino acid mixture, and 5.5 hours after intake of the amino acid mixture]

Secondary Outcome(s)

Emotional Responsiveness [Time Frame: There will be 4 measurements spread over 2 testing days with a wash-out period of min. 1 weak. baseline measure, 3.5 hours after intake of the amino-acid mixture]

Impulsivity [Time Frame: There will be 6 measurements spread over 2 testing days with a wash-out period of min. 1 weak. baseline measure, 3.5 hours after intake of the amino-acid mixture, and 5.5 hours after intake of the amino-acid mixture]

Motor scores [Time Frame: There will be 6 measurements spread over 2 testing days with a wash-out period of min. 1 weak. baseline measure, 3.5 hours after intake of the amino-acid mixture, and 5.5 hours after intake of the amino-acid mixture]

Secondary ID(s)

Tryptophan depletion in PD

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Netherlands Brain Foundation