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Tryptophan Depletion in PD Patients Treated With STN DBS

NCT02632279 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2018-08-22

No results posted yet for this study

Summary

The purpose of this study is to assess the effect of tryptophan depletion on mood and behavior in Parkinson's disease (PD) patients treated with deep brain stimulation (DBS) of the subthalamic nucleus (STN). By doing this, the investigators hope to be able to identify risk factors for and mechanisms underlying psychiatric side effects of STN DBS. The study will be an intervention study with a placebo controlled, randomized cross-over design.

Conditions

Interventions

DIETARY_SUPPLEMENT

Tryptophan (TRP) depletion

TRP depletion will be accomplished by administering a TRP-low amino acid protein drink containing 100 g of gelatin powder. The protein mixture consists of 18 amino acids. According to Dutch law, TRP is considered a food supplement and is not registered as a medicine.

DIETARY_SUPPLEMENT

Placebo

The placebo treatment will consist of an identical amino acid protein drink containing 100 g of gelatin powder to which 1.21g TRP is added.

DEVICE

Stimulator ON

Participants will be tested while their stimulator is turned ON

DEVICE

Stimulator OFF

Participans will be tested while their stimulator is turned OFF

Sponsors & Collaborators

  • Netherlands Brain Foundation

    collaborator OTHER

  • Maastricht University Medical Center

    lead OTHER

Principal Investigators

  • Yasin Temel, MD, PhD · Maastricht University Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-11-30
Primary Completion
2017-11-30
Completion
2017-11-15

Countries

  • Netherlands

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02632279 on ClinicalTrials.gov