Targeting Dopamine Therapy in RLS

This study is not yet open for participant recruitment.
Verified December 2013 by Tel-Aviv Sourasky Medical Center
Sponsor:
Information provided by (Responsible Party):
Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier:
NCT01937169
First received: September 3, 2013
Last updated: December 17, 2013
Last verified: December 2013
  Purpose

Neurons in the brain require blood and oxygen for proper function. The term "neurovascular coupling" has been postulated in the 19th century by Roy & Sherrington referring to increased blood flow to active neurons. The rationale of this research relies on the neurovascular coupling, suggesting that increased blood flow to active regions on the brain should supply not only more blood, but also more of a pharmacological agent present in the blood system at the time. Thus, active regions should be affected by the agent (=drug) to a greater extent.

In the present study we focus on the dopaminergic system, critical in many functions such as cognition, response to stimuli and movement. One of the well-known dopaminergic pathways in the brain is the nigrostriatal pathway, mediating motor function. In this research, we intend to examine the effects of coupling functional activation in this pathway with a dopaminergic agent, Carbidopa/Levodopa, on symptoms of Restless Leg Syndrome (RLS). RLS is characterized by an irresistible urge to move the limbs (i.e. Akathisia), and results most prominently by a significant decrease in the quality of sleep. Our research focuses on this symptom of RLS to examine the effect of coupling brain activation and drug treatment.

The first line of treatment in RLS is dopaminergic drugs. These drugs increase dopamine levels in motor pathways, and our research will aim to couple activation in the nigrostriatal motor pathway with dopaminergic treatment in RLS. Functional activation will be achieved with a simple motor task, known to elicit activation in the nigrostriatal pathway. We hypothesize that the drug will act upon the pre-activated motor system, and that this coupling between brain activation and drug treatment will ameliorate sleep-related symptoms of RLS, compared with treating these symptoms solely with a dopaminergic drug and compared with using a non-motor task.


Condition Intervention
Restless Legs Syndrome
Behavioral: Motor Task
Drug: Levodopa tablet
Behavioral: Sham non-motor task
Drug: Placebo pill

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Tel-Aviv Sourasky Medical Center:

Primary Outcome Measures:
  • Efficacy [ Time Frame: 1 week ] [ Designated as safety issue: No ]
    Nighttime measures of motor activity will be used to assess the efficacy of treatment intervention


Secondary Outcome Measures:
  • reported efficacy [ Time Frame: 1 week ] [ Designated as safety issue: No ]
    Participant's reports of the quality of sleep will be recorded


Estimated Enrollment: 30
Study Start Date: January 2014
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Drug + motor task

Each participant will undergo physical examination by an doctor. Then, the participant will receive the Fitbit device with instructions for proper use. The next stages will take place at the participant's home environment.

Each participant will monitor motor activity in hours prior to sleep and at night for assessing baseline activity level. After 3 nights of monitoring, each participant will be administered with a quarter of a Dopicar pill (4th night) and half a Dopical pill (5th night), measuring different dose effect on motor activity during sleep.This group will be administered with a quarter of a Dopicar pill, 1 hour prior to sleep. After 15 minutes, participants in this group will perform a motor task (e.g., walking) for 30 minutes.

Behavioral: Motor Task
A motor task executed for 30 minutes after drug adminidtration
Drug: Levodopa tablet
Placebo Comparator: Placebo + motor task

Each participant will undergo physical examination by an doctor. Then, the participant will receive the Fitbit device with instructions for proper use. The next stages will take place at the participant's home environment.

Each participant will monitor motor activity in hours prior to sleep and at night for assessing baseline activity level. After 3 nights of monitoring, each participant will be administered with a quarter of a Dopicar pill (4th night) and half a Dopical pill (5th night), measuring different dose effect on motor activity during sleep. This group will be administered with a quarter of a Placebo pill, 1 hour prior to sleep. After 15 minutes, participants in this group will perform a motor task (e.g., walking) for 30 minutes.

Behavioral: Motor Task
A motor task executed for 30 minutes after drug adminidtration
Drug: Placebo pill
Sham Comparator: Dopicar + Sham task

Each participant will undergo physical examination by an doctor. Then, the participant will receive the Fitbit device with instructions for proper use. The next stages will take place at the participant's home environment.

Each participant will monitor motor activity in hours prior to sleep and at night for assessing baseline activity level. After 3 nights of monitoring, each participant will be administered with a quarter of a Dopicar pill (4th night) and half a Dopical pill (5th night), measuring different dose effect on motor activity during sleep. This group will be administered with a quarter of a Dopicar pill, 1 hour prior to sleep. After 15 minutes, participants in this group will perform a non-motor task (e.g., crossword puzzle) for 30 minutes.

Drug: Levodopa tablet Behavioral: Sham non-motor task
A non-motor task )sham condition) will be executed for 30 minutes after drug adminidtration

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

RLS diagnosis according the common clinical criteria No known neurological illnesses No known Kidney illnesses No known iron deficiency No history of drug or alcohol use

Exclusion Criteria:

Regular drug treatment Use of a psychotropic substance in the two weeks prior to the study Auditory or Visual impairment Psychiatric history Neurological illness Chronic Kidney illness Obstructive Sleep Apnea (OSA) Dopaminergic drug intolerance or sensitivity Glaucoma Melanoma or Pre-Melanoma (current or previous) Pregnancy

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01937169

Contacts
Contact: Haggai Sharon, MD haggais@tlvmc.gov.il

Locations
Israel
Tel Aviv Sourasky Medical Center Not yet recruiting
Tel Aviv, N/A = Not Applicable, Israel, 64288
Contact: Haggai Sharon, MD       haggais@tlvmc.gov.il   
Sponsors and Collaborators
Tel-Aviv Sourasky Medical Center
  More Information

No publications provided

Responsible Party: Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier: NCT01937169     History of Changes
Other Study ID Numbers: TASMC-13-TH-0416-CTIL
Study First Received: September 3, 2013
Last Updated: December 17, 2013
Health Authority: Israel: Ministry of Health

Additional relevant MeSH terms:
Restless Legs Syndrome
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases
Parasomnias
Mental Disorders
Levodopa
Antiparkinson Agents
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 17, 2014