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NCT01675323 · ClinicalTrials.gov registry record
Glutamate, Hyperarousal and Restless Legs Syndrome
A clinical trial, sponsored by Johns Hopkins University.
- Completed
- Registry status
- 77
- Enrollment target
NCT01675323: Completed study, sponsored by Johns Hopkins University.
NCT01675323 is a clinical trial that has completed, run by Johns Hopkins University. The registered enrollment target is 77 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01675323 has completed, sponsored by Johns Hopkins University.
- COMPLETED
- Registry status
- 77 participants
- Enrollment target
Study Summary
Restless Legs Syndrome (RLS) research has focused on the sensory features and failed to address an important aspect of RLS; i.e. a 'hyperarousal' or profound chronic sleep loss without significant excessive daytime sleepiness. This hyperarousal produces RLS symptoms by overwhelming the normal inhibitory processes needed to decrease sensory and motor cortical activity for resting and sleep. Thus the hyperarousal produces both the RLS need to move when trying to rest and the inability to maintain sleep. The biological consequences of this hyperarousal process on sleep (increased wake time) and cortical excitability (as demonstrated by transcranial magnetic stimulation (TMS)) are postulated to reflect increased degree of excitatory glutamatergic activity, and therefore affected brain regions will show relatively increased glutamate (Glu) and glutamine (Gln) on MR spectroscopy (MRS). Changes in inhibitory activity and GABA may also occur, but less significantly than the increase in Glu/Gln. Our pilot MRS data discovered a new abnormality in RLS: increased Thalamic Glx (Glu + Gln) that correlated well with sleep measures of hyperarousal. Glx levels are not specific for the neurotransmitter role of Glu. In this project RLS and matching controls subjects will be studied using polysomnograms (PSG) and TMS and 7T MRI for MRS that provides accurate measurement of Gln levels, which reflect mostly neurotransmitter Glu activity. The first aim is to confirm that Gln is increased in the thalamus and to determine if this also occurs in the motor and sensory cortices. The relation between Glu, Gln and GABA will also be evaluated. Second, assessments will be made of the degree of relation between Gln increase and the hyperarousal effects on sleep and cortical excitability (TMS). This would demonstrate that abnormally increased Glu activity is primary to RLS hyperarousal and radically changes the emphasis in RLS to be less on dopamine and more on Glu-hyperarousal as a major feature o
Primary Outcome
Study of thalamic glutamate levels in the brain using MR Spectroscopy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 77 participants |
| Start Date | 2012-08 |
| Est. Completion | 2016-07 |
What the finished NCT01675323 record still lists
NCT01675323 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 77 participants, a relatively small participant target.
The record links to 0 conditions, and to 0 interventions.
NCT01675323 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01675323 about?
NCT01675323 is a clinical study titled "Glutamate, Hyperarousal and Restless Legs Syndrome". Restless Legs Syndrome (RLS) research has focused on the sensory features and failed to address an important aspect of RLS; i.e. a 'hyperarousal' or profound chronic sleep loss without significant excessive daytime sleepiness. This hyperarousal produces RLS symptoms by overwhelming the normal inhibi...
What is the current status of trial NCT01675323?
This trial is currently completed. The enrollment target is 77 participants. The study started on 2012-08. Estimated completion is 2016-07.
Who is sponsoring clinical trial NCT01675323?
This trial is sponsored by Johns Hopkins University, which has 1,448 total clinical trials registered on ClinicalTrials.gov.
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