Restless Legs SyndromeRLSNCT01109537
Altered Brain GABA and Glutamate in Restless Legs Syndrome
An observational study of Restless Legs Syndrome, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
The purpose of the study is to understand the brain chemistry of people with Restless Legs Syndrome (RLS). The primary hypothesis is that patients with RLS will have reduced GABA levels in their Thalamus and elevated Glutamate levels in their Anterior Cingulate Cortex. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Restless Legs Syndrome
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2010to May 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Male and female subjects who have RLS or are normal controls will be recruited from the greater Boston metropolitan area. We anticipate enrolling 70 subjects with RLS and 70 normal controls, under a plan to complete 15 subjects in each group.
Who may be able to join
- Subjects at least 18 years of age
- Subjects with a diagnosis of RLS using the International RLS Study Group (IRLSSG) criteria
- Subjects with a history of RLS symptoms at least 15 nights in the prior month, or, if on treatment, this frequency of symptoms before treatment was started
Who cannot join
- Subjects who are unable to discontinue prohibited medications prior to sleep study and 1H-MRS. These include any CNS-active medications. For RLS subjects, RLS-related medications (e.g. dopaminergic agents and alpha 2-delta agents) must be discontinued a minimum of 48 hours prior to PSG. In the RLS group, benzodiazepines must be discontinued a minimum of one week prior to PSG. For normal controls with regular treatment (>1 time/wk) with CNS active agents within 1 month of screening visit will also be excluded.
- Subjects with an active or unstable major psychiatric disorder requiring further treatment (e.g., major depressive disorder). Subjects with clinically significant depression, or with clinically significant anxiety, or who, in the investigator's judgment might require intervention with either pharmacological or non-pharmacological therapy over the course of the study.
- Subjects with clinical evidence of any untreated moderate to severe sleep disorder other than RLS (forRLS group) (e.g. obstructive sleep apnea, insomnia, narcolepsy, delayed sleep phase syndrome, etc.) within the preceding year
- Subjects with an apnea-hypopnea index (AHI) > 15 at the polysomnography visit
- Subjects who consume beverages containing more than 400mg of caffeine per day
- Subjects who consume more than 14 alcoholic units in any week, or more than 5 alcoholic units in any single day, over the month preceding the screening visit.
Show all 21Show fewer
- Females who are pregnant or lactating
- Subjects with a history of neurologic illness (e.g. brain neoplasm, multiple sclerosis), significant or unstable medical illness (e.g. congestive heart failure, diabetes mellitus), or history of significant head trauma or loss of consciousness > 30 minutes
- Subjects who have positive urine drug screening (phencyclidine, cocaine, amphetamines, tetrahydrocannabinol, and opiates) at the screening visit or at the MRS visit.
- Contraindications to MRS scans, including:
- Cardiac pacemakers
- Aneurysm clips and other vascular stents, filters, clips or other devices
- Prosthetic heart values
- Other prostheses
- Neuro-stimulator devices
- Implanted infusion pumps
- Cochlear (ear) implants
- Ocular (eye) implants or known metal fragments in eyes
- Exposure to shrapnel or metal filings (sheetmetal workers, welders, and others)
- Other metallic surgical hardware in vital areas
- Severe claustrophobia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Thalamic and Anterior Cingulate Cortex GABA and Glutamate in Restless Legs Syndrome: A 1-HMRS Study
The purpose of the study is to understand the brain chemistry of people with Restless Legs Syndrome (RLS). The primary hypothesis is that patients with RLS will have reduced GABA levels in their Thalamus and elevated Glutamate levels in their Anterior Cingulate Cortex. The study will use MRS imaging to examine the regional levels of these neurochemicals, GABA and Glutamate, in the brain.
Read the detailed description
The study will involve a screening visit, a washout period for those taking RLS medications, a night of actigraphy, an overnight polysomnogram, an MRI scan, and an MRS scan. The polysomnography and MR scan visits will occur on consecutive days.
Visit 1: Screening Visit
The informed consent process for the study will be completed and a signed informed consent form will be obtained. All subjects with RLS will undergo a clinical interview in order to confirm or exclude an RLS diagnosis consistent with the International Restless Legs Syndrome Study Group criteria and to determine the presence of any psychiatric or medical disorders. The following study assessments will be completed:
- International Restless Legs Syndrome Scale (IRLS) (RLS subjects only)
- Clinical Global Impression-Severity (CGI) (RLS subjects only)
- Insomnia Severity Index (ISI)
- Beck Depression Inventory
- Pittsburgh Sleep Quality Index (PSQI)
- Hamilton Anxiety Scale (HAM-A)
- Sleep Health Centers Questionnaire
- Metal implant questionnaire
All women will have a urine pregnancy test and all subjects will have a urine sample for drug screening collected.
Washout Period
Subjects in the RLS group will be required to discontinue their RLS medications at least 48 hours prior to the PSG.
Actigraphy
An actigraph will be used to record limb movements of both legs the night before the PSG. The actigraph will be worn from the subjects' bedtime until the subjects' final wake time Subjects will also record their bedtime and wake time on the Actigraphy Data Form. Data from the night of actigraphy will be used to monitor subjects' sleep.
Visit 2: Polysomnography (PSG) The PSG will occur on the night prior to the MRS visit. The time of lights out during all PSG sessions will be determined for each subject based on self report of usual bedtime.
Channels will include an electroencephalograph (EEG), an electro-oculogram (EOG), a submental electromyography (EMG), EMG of both anterior tibialis muscles (separate channels for each leg), oral/nasal airflow, pulse oximetry, and respiratory effort. The PSG will be analyzed for traditional sleep staging. Measures from the PSG will include Sleep Onset Latency (SOL), Wake After Sleep Onset (WASO), Sleep Efficiency (SE), N-REM and REM percentages, Periodic Limb Movement Index (PLMI) and PLMs associated with arousal per hour of sleep (PLMAI).
Visit 3: MR scans
Following visits 1 and 2, qualified subjects will undergo Magnetic Resonance brain scans the Brain Imaging Center of McLean Hospital in Belmont, MA. Prior to MR scanning, subjects will be questioned for a second time about the presence of metallic implants and fragments or any other contraindications to MR imaging. They will be asked about recent alcohol, drug (licit and illicit), and caffeine use. They will also be asked to provide a urine sample for drug screening. Women will take a urine pregnancy test. Also, since brain GABA levels can be affected by the menstrual cycle, women will be scheduled to have their MR scans during the first portion of their menstrual cycle. Subjects will also be asked to complete the following assessments before the MR scans:
- IRLS (modified)
- Medical Outcomes Study Sleep Scale (modified) (MOS)
- Profile of Mood States (POMS)
- Patient Global Impression-Severity (PGI-S)
- State Trait Anxiety Inventory (STAI)
Subjects will undergo proton magnetic resonance spectroscopy (MRS) at 4T. In addition, in accordance with the McLean Hospital Neuroimaging center guidelines, subjects will additionally have a MR screening scan at either 1.5T or 3T. All MR recordings will be obtained using parameters that are within FDA safety guidelines for exposure to static magnetic fields, radio-frequency energy deposition, magnetic field switching rates and acoustic noise levels. GABA and glutamate levels will be derived from MRS Scan at 4T. Subjects will be in each scanner for approximately one hour. At the conclusion of each scan, subjects will be queried regarding any adverse effects related to MR scans. The subject will have completed the study at the conclusion of the MR scans.
During the MRS at 4T, patients will complete a modified Suggested Immobilization Test (SIT). During the SIT, the subjects will be asked by study staff to verbally rate the level of discomfort in their legs on a scale from 1 (no discomfort) to 10 (extreme discomfort). Subjects will be asked to make a rating in five minute intervals over one hour.
In the case that MR scans on the 1.5T/3T and 4T MR scanners cannot be coordinated on the same visit day at the McLean Brain Imaging center due to scheduling conflicts, the subject will be offered the opportunity to return to McLean to have the remaining scan on a separate day. Subjects will still be offered $50 for completion of each scan. Also, in the case that the data collected during MR imaging is not usable (due to technical problems with the scanner, excessive noise in the measurement, etc.), the subject may be contacted and offered a repeat MRS scan on a separate date. Subjects will be compensated an additional $100 for completion of such a repeat MRS scan.
The Primary Endpoints of this protocol are regional GABA and glutamate levels derived from 4T MRS.
- Conditions
- Restless Legs Syndrome
- Keywords
- Restless Legs Syndrome (RLS), GABA, Glutamate, Magnetic Resonance Spectroscopy
- Medical subject headings
- Restless Legs Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| RLS Diagnosis | Not described | |
| Healthy Controls | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Regional GABA and glutamate levels derived from 4T MRS.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2010 (estimated)
- Study startApr 2010
- Primary completionMay 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Restless Legs SyndromeStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- GlaxoSmithKline
- Responsible party
- Principal investigator, John W. Winkelman, MD, PhD, Brigham and Women's Hospital
- Investigators
- John W Winkelman, MD, PhD, Principal investigator, Sleep Health Centers, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01109537
- Sponsor's protocol ID
- BWH-2010-12345
- Acronym
- RLS
- Status last verified
- Jan 2015
- First submitted
- 22 Apr 2010
- Last updated
- 7 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Bucher SF, Seelos KC, Oertel WH, Reiser M, Trenkwalder C. Cerebral generators involved in the pathogenesis of the restless legs syndrome. Ann Neurol. 1997 May;41(5):639-45. doi: 10.1002/ana.410410513.
PubMed 9153526Price DD. Psychological and neural mechanisms of the affective dimension of pain. Science. 2000 Jun 9;288(5472):1769-72. doi: 10.1126/science.288.5472.1769.
PubMed 10846154Cervenka S, Palhagen SE, Comley RA, Panagiotidis G, Cselenyi Z, Matthews JC, Lai RY, Halldin C, Farde L. Support for dopaminergic hypoactivity in restless legs syndrome: a PET study on D2-receptor binding. Brain. 2006 Aug;129(Pt 8):2017-28. doi: 10.1093/brain/awl163. Epub 2006 Jul 1.
PubMed 16816393von Spiczak S, Whone AL, Hammers A, Asselin MC, Turkheimer F, Tings T, Happe S, Paulus W, Trenkwalder C, Brooks DJ. The role of opioids in restless legs syndrome: an [11C]diprenorphine PET study. Brain. 2005 Apr;128(Pt 4):906-17. doi: 10.1093/brain/awh441. Epub 2005 Feb 23.
PubMed 15728657Spiegelhalder K, Feige B, Paul D, Riemann D, van Elst LT, Seifritz E, Hennig J, Hornyak M. Cerebral correlates of muscle tone fluctuations in restless legs syndrome: a pilot study with combined functional magnetic resonance imaging and anterior tibial muscle electromyography. Sleep Med. 2008 Jan;9(2):177-83. doi: 10.1016/j.sleep.2007.03.021. Epub 2007 Jul 16.
PubMed 17638594Etgen T, Draganski B, Ilg C, Schroder M, Geisler P, Hajak G, Eisensehr I, Sander D, May A. Bilateral thalamic gray matter changes in patients with restless legs syndrome. Neuroimage. 2005 Feb 15;24(4):1242-7. doi: 10.1016/j.neuroimage.2004.10.021. Epub 2004 Dec 8.
PubMed 15670702Winkelman JW, Redline S, Baldwin CM, Resnick HE, Newman AB, Gottlieb DJ. Polysomnographic and health-related quality of life correlates of restless legs syndrome in the Sleep Heart Health Study. Sleep. 2009 Jun;32(6):772-8. doi: 10.1093/sleep/32.6.772.
PubMed 19544754Kushida CA, Allen RP, Atkinson MJ. Modeling the causal relationships between symptoms associated with restless legs syndrome and the patient-reported impact of RLS. Sleep Med. 2004 Sep;5(5):485-8. doi: 10.1016/j.sleep.2004.04.004.
PubMed 15341894
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thalamic and Anterior Cingulate Cortex GABA and Glutamate in Restless Legs Syndrome: A 1-HMRS Study
- ClinicalTrials.gov ID
- NCT01109537
- Acronym / sponsor ID
- RLS / BWH-2010-12345
- Conditions
- Restless Legs Syndrome
- Keywords
- Restless Legs Syndrome (RLS), GABA, Glutamate, Magnetic Resonance Spectroscopy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- GlaxoSmithKline
- Study start
- Apr 2010
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 23 Apr 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to understand the brain chemistry of people with Restless Legs Syndrome (RLS). The primary hypothesis is that patients with RLS will have reduced GABA levels in their Thalamus and elevated Glutamate levels in their Anterior Cingulate Cortex. The study will use MRS imaging to examine the regional levels of these neurochemicals, GABA and Glutamate, in the brain.
Detailed description
The study will involve a screening visit, a washout period for those taking RLS medications, a night of actigraphy, an overnight polysomnogram, an MRI scan, and an MRS scan. The polysomnography and MR scan visits will occur on consecutive days.
Visit 1: Screening Visit
The informed consent process for the study will be completed and a signed informed consent form will be obtained. All subjects with RLS will undergo a clinical interview in order to confirm or exclude an RLS diagnosis consistent with the International Restless Legs Syndrome Study Group criteria and to determine the presence of any psychiatric or medical disorders. The following study assessments will be completed:
- International Restless Legs Syndrome Scale (IRLS) (RLS subjects only)
- Clinical Global Impression-Severity (CGI) (RLS subjects only)
- Insomnia Severity Index (ISI)
- Beck Depression Inventory
- Pittsburgh Sleep Quality Index (PSQI)
- Hamilton Anxiety Scale (HAM-A)
- Sleep Health Centers Questionnaire
- Metal implant questionnaire
All women will have a urine pregnancy test and all subjects will have a urine sample for drug screening collected.
Washout Period
Subjects in the RLS group will be required to discontinue their RLS medications at least 48 hours prior to the PSG.
Actigraphy
An actigraph will be used to record limb movements of both legs the night before the PSG. The actigraph will be worn from the subjects' bedtime until the subjects' final wake time Subjects will also record their bedtime and wake time on the Actigraphy Data Form. Data from the night of actigraphy will be used to monitor subjects' sleep.
Visit 2: Polysomnography (PSG) The PSG will occur on the night prior to the MRS visit. The time of lights out during all PSG sessions will be determined for each subject based on self report of usual bedtime.
Channels will include an electroencephalograph (EEG), an electro-oculogram (EOG), a submental electromyography (EMG), EMG of both anterior tibialis muscles (separate channels for each leg), oral/nasal airflow, pulse oximetry, and respiratory effort. The PSG will be analyzed for traditional sleep staging. Measures from the PSG will include Sleep Onset Latency (SOL), Wake After Sleep Onset (WASO), Sleep Efficiency (SE), N-REM and REM percentages, Periodic Limb Movement Index (PLMI) and PLMs associated with arousal per hour of sleep (PLMAI).
Visit 3: MR scans
Following visits 1 and 2, qualified subjects will undergo Magnetic Resonance brain scans the Brain Imaging Center of McLean Hospital in Belmont, MA. Prior to MR scanning, subjects will be questioned for a second time about the presence of metallic implants and fragments or any other contraindications to MR imaging. They will be asked about recent alcohol, drug (licit and illicit), and caffeine use. They will also be asked to provide a urine sample for drug screening. Women will take a urine pregnancy test. Also, since brain GABA levels can be affected by the menstrual cycle, women will be scheduled to have their MR scans during the first portion of their menstrual cycle. Subjects will also be asked to complete the following assessments before the MR scans:
- IRLS (modified)
- Medical Outcomes Study Sleep Scale (modified) (MOS)
- Profile of Mood States (POMS)
- Patient Global Impression-Severity (PGI-S)
- State Trait Anxiety Inventory (STAI)
Subjects will undergo proton magnetic resonance spectroscopy (MRS) at 4T. In addition, in accordance with the McLean Hospital Neuroimaging center guidelines, subjects will additionally have a MR screening scan at either 1.5T or 3T. All MR recordings will be obtained using parameters that are within FDA safety guidelines for exposure to static magnetic fields, radio-frequency energy deposition, magnetic field switching rates and acoustic noise levels. GABA and glutamate levels will be derived from MRS Scan at 4T. Subjects will be in each scanner for approximately one hour. At the conclusion of each scan, subjects will be queried regarding any adverse effects related to MR scans. The subject will have completed the study at the conclusion of the MR scans.
During the MRS at 4T, patients will complete a modified Suggested Immobilization Test (SIT). During the SIT, the subjects will be asked by study staff to verbally rate the level of discomfort in their legs on a scale from 1 (no discomfort) to 10 (extreme discomfort). Subjects will be asked to make a rating in five minute intervals over one hour.
In the case that MR scans on the 1.5T/3T and 4T MR scanners cannot be coordinated on the same visit day at the McLean Brain Imaging center due to scheduling conflicts, the subject will be offered the opportunity to return to McLean to have the remaining scan on a separate day. Subjects will still be offered $50 for completion of each scan. Also, in the case that the data collected during MR imaging is not usable (due to technical problems with the scanner, excessive noise in the measurement, etc.), the subject may be contacted and offered a repeat MRS scan on a separate date. Subjects will be compensated an additional $100 for completion of such a repeat MRS scan.
The Primary Endpoints of this protocol are regional GABA and glutamate levels derived from 4T MRS.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RLS Diagnosis | – | – |
| Healthy Controls | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Male and female subjects who have RLS or are normal controls will be recruited from the greater Boston metropolitan area. We anticipate enrolling 70 subjects with RLS and 70 normal controls, under a plan to complete 15 subjects in each group.
Key inclusion criteria (3 listed)
- Subjects at least 18 years of age
- Subjects with a diagnosis of RLS using the International RLS Study Group (IRLSSG) criteria
- Subjects with a history of RLS symptoms at least 15 nights in the prior month, or, if on treatment, this frequency of symptoms before treatment was started
Key exclusion criteria (21 listed)
- Subjects who are unable to discontinue prohibited medications prior to sleep study and 1H-MRS. These include any CNS-active medications. For RLS subjects, RLS-related medications (e.g. dopaminergic agents and alpha 2-delta agents) must be discontinued a minimum of 48 hours prior to PSG. In the RLS group, benzodiazepines must be discontinued a minimum of one week prior to PSG. For normal controls with regular treatment (>1 time/wk) with CNS active agents within 1 month of screening visit will also be excluded.
- Subjects with an active or unstable major psychiatric disorder requiring further treatment (e.g., major depressive disorder). Subjects with clinically significant depression, or with clinically significant anxiety, or who, in the investigator's judgment might require intervention with either pharmacological or non-pharmacological therapy over the course of the study.
- Subjects with clinical evidence of any untreated moderate to severe sleep disorder other than RLS (forRLS group) (e.g. obstructive sleep apnea, insomnia, narcolepsy, delayed sleep phase syndrome, etc.) within the preceding year
- Subjects with an apnea-hypopnea index (AHI) > 15 at the polysomnography visit
- Subjects who consume beverages containing more than 400mg of caffeine per day
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Regional GABA and glutamate levels derived from 4T MRS.
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2015.
- Background: PubMed 9153526Bucher SF, Seelos KC, Oertel WH, Reiser M, Trenkwalder C. Cerebral generators involved in the pathogenesis of the restless legs syndrome. Ann Neurol. 1997 May;41(5):639-45. doi: 10.1002/ana.410410513.
- Background: PubMed 10846154Price DD. Psychological and neural mechanisms of the affective dimension of pain. Science. 2000 Jun 9;288(5472):1769-72. doi: 10.1126/science.288.5472.1769.
- Background: PubMed 16816393Cervenka S, Palhagen SE, Comley RA, Panagiotidis G, Cselenyi Z, Matthews JC, Lai RY, Halldin C, Farde L. Support for dopaminergic hypoactivity in restless legs syndrome: a PET study on D2-receptor binding. Brain. 2006 Aug;129(Pt 8):2017-28. doi: 10.1093/brain/awl163. Epub 2006 Jul 1.
- Background: PubMed 15728657von Spiczak S, Whone AL, Hammers A, Asselin MC, Turkheimer F, Tings T, Happe S, Paulus W, Trenkwalder C, Brooks DJ. The role of opioids in restless legs syndrome: an [11C]diprenorphine PET study. Brain. 2005 Apr;128(Pt 4):906-17. doi: 10.1093/brain/awh441. Epub 2005 Feb 23.
- Background: PubMed 17638594Spiegelhalder K, Feige B, Paul D, Riemann D, van Elst LT, Seifritz E, Hennig J, Hornyak M. Cerebral correlates of muscle tone fluctuations in restless legs syndrome: a pilot study with combined functional magnetic resonance imaging and anterior tibial muscle electromyography. Sleep Med. 2008 Jan;9(2):177-83. doi: 10.1016/j.sleep.2007.03.021. Epub 2007 Jul 16.
- Background: PubMed 15670702Etgen T, Draganski B, Ilg C, Schroder M, Geisler P, Hajak G, Eisensehr I, Sander D, May A. Bilateral thalamic gray matter changes in patients with restless legs syndrome. Neuroimage. 2005 Feb 15;24(4):1242-7. doi: 10.1016/j.neuroimage.2004.10.021. Epub 2004 Dec 8.
- Background: PubMed 19544754Winkelman JW, Redline S, Baldwin CM, Resnick HE, Newman AB, Gottlieb DJ. Polysomnographic and health-related quality of life correlates of restless legs syndrome in the Sleep Heart Health Study. Sleep. 2009 Jun;32(6):772-8. doi: 10.1093/sleep/32.6.772.
- Background: PubMed 15341894Kushida CA, Allen RP, Atkinson MJ. Modeling the causal relationships between symptoms associated with restless legs syndrome and the patient-reported impact of RLS. Sleep Med. 2004 Sep;5(5):485-8. doi: 10.1016/j.sleep.2004.04.004.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John W Winkelman, MD, PhD principal investigator
Sleep Health Centers, Brigham and Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Restless Legs Syndrome, run by Brigham and Women's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Regional GABA and glutamate levels derived from 4T MRS. (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01109537, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2015.