Multiple SclerosisNCT01023074
Effects of Training on Central Auditory Function in Multiple Sclerosis
A study testing Auditory training in people with Multiple Sclerosis, run by VA Office of Research and Development at 1 site in United States.
Trial summary
The purpose of this study is to characterize the central auditory processing (CAP) deficits that result from multiple sclerosis (MS). Read more about this study
- Who is it for?
- Ages 21 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Auditory training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2007to Jun 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 21 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age 21-65 years;
- a clinical or laboratory supported diagnosis of "definite" MS;
- a diagnosis of relapsing-remitting, primary progressive, or secondary progressive MS;
- a Kurtzke Expanded Disability Status Score (EDSS) of 0 to 7.0, inclusive;
- no history of a clinical relapse or change in EDSS for three months preceding entry into the study; and
- a brain MRI scan that shows at least three white-matter lesions on T2-weighted images consistent with MS
Who cannot join
- current major disease or disorder other than MS (e.g., cancer, end-stage renal disease, end-stage cardiopulmonary disease, post-traumatic stress disorder, diabetes);
- other neurological conditions that could interfere with the ability to respond to tests and questionnaires;
- non-native speaker of English (since test materials are presented in English);
- pregnant (due to potential negative effects on the fetus during fMRI);
- more than a mild degree (less than a 40 dB HL four-frequency pure-tone average [PTA]) of hearing loss bilaterally (since the presence of more than a mild degree of peripheral hearing impairment may impact CAP test results);
- metal implants (due to fMRI constraints); and
- left-handedness
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Portland Health Care System, Portland, OR
Portland, Oregon, 97239
About this study
The purpose of this study is to characterize the central auditory processing (CAP) deficits that result from multiple sclerosis (MS).
Read the detailed description
Five general types of evaluations will be employed over multiple study sessions at the National Center for Rehabilitative Auditory Research (NCRAR). First, a neurologist will review the subject's medical history and perform a neurologic exam to confirm MS diagnosis. Second, peripheral auditory function will be evaluated using a standard set of routine audiometric tests. Additionally, subjects will complete a case history and series of hearing handicap inventories. Third, a battery of behavioral procedures will be used to characterize central auditory processing. Fourth, auditory evoked potential studies will be performed. Emphasis here will be upon evoked potentials whose putative neural generators lie within the central auditory nervous system. Fifth, subjects will receive magnetic resonance imaging (MRI) evaluation to determine sites and amount of neural degeneration.
- Conditions
- Multiple Sclerosis
- Being tested
- Auditory training, MS: Control Activity
- Keywords
- MS, CAP
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Auditory trainingBehavioural
the study was originally set up so that half of the MS subjects would received auditory training. This intervention has since been discontinued.
MS: Control ActivityOther
MS group not receiving auditory training, doing control activity
| Study group | Role | What they receive |
|---|---|---|
| Non-MS Control | No intervention | Non-MS control group |
| MS: Auditory Training | Active comparator | MS group receiving auditory training Receives: Behavioral: Auditory training |
| MS: Control Activity | Placebo comparator | MS group not receiving auditory training, doing control activity Receives: Other: MS: Control Activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Electrophysiological Auditory Test
auditory P300 amplitude in response to "rare" 1000 Hz tones
Measured: Recordings were conducted during one session
Secondary outcomes (2)
Neural Magnetic Resonance Imaging (MRI)
Gray matter volume
Measured: Results were recorded during one scanning session
SCAN-A: Competing Words Test
The SCAN-A: Competing Words Test assesses participants' auditory processing abilities via a dichotic listening task. Lists of word pairs are presented separately to each ear, and participants repeat the words they hear. Possible range of scores = 0-20, with higher scores indicating better performance.
Measured: Test administered during one session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2009 (estimated)
- Study startOct 2007
- Primary completionJun 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Collaborators
- Oregon Health and Science University
- Responsible party
- Sponsor
- Investigators
- Dennis N. Bourdette, MD, Principal investigator, VA Portland Health Care System, Portland, OR
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01023074
- Sponsor's protocol ID
- B4762-R
- Other IDs
- NCRAR-VA-04-1205, OHSU - 3188
- Status last verified
- Sep 2018
- First submitted
- 30 Nov 2009
- Last updated
- 9 Oct 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Training on Central Auditory Function in Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT01023074
- Acronym / sponsor ID
- B4762-R
- Conditions
- Multiple Sclerosis
- Keywords
- MS, CAP
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Collaborators
- Oregon Health and Science University
- Study start
- Oct 2007
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 2 Dec 2009 (estimated)
- Results
- Posted 17 Mar 2015
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 this study is to characterize the central auditory processing (CAP) deficits that result from multiple sclerosis (MS).
Detailed description
Five general types of evaluations will be employed over multiple study sessions at the National Center for Rehabilitative Auditory Research (NCRAR). First, a neurologist will review the subject's medical history and perform a neurologic exam to confirm MS diagnosis. Second, peripheral auditory function will be evaluated using a standard set of routine audiometric tests. Additionally, subjects will complete a case history and series of hearing handicap inventories. Third, a battery of behavioral procedures will be used to characterize central auditory processing. Fourth, auditory evoked potential studies will be performed. Emphasis here will be upon evoked potentials whose putative neural generators lie within the central auditory nervous system. Fifth, subjects will receive magnetic resonance imaging (MRI) evaluation to determine sites and amount of neural degeneration.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Non-MS Control | No intervention | –Non-MS control group |
| MS: Auditory Training | Active comparator | Behavioral: Auditory trainingMS group receiving auditory training |
| MS: Control Activity | Placebo comparator | Other: MS: Control ActivityMS group not receiving auditory training, doing control activity |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- age 21-65 years;
- a clinical or laboratory supported diagnosis of "definite" MS;
- a diagnosis of relapsing-remitting, primary progressive, or secondary progressive MS;
- a Kurtzke Expanded Disability Status Score (EDSS) of 0 to 7.0, inclusive;
- no history of a clinical relapse or change in EDSS for three months preceding entry into the study; and
Key exclusion criteria (7 listed)
- current major disease or disorder other than MS (e.g., cancer, end-stage renal disease, end-stage cardiopulmonary disease, post-traumatic stress disorder, diabetes);
- other neurological conditions that could interfere with the ability to respond to tests and questionnaires;
- non-native speaker of English (since test materials are presented in English);
- pregnant (due to potential negative effects on the fetus during fMRI);
- more than a mild degree (less than a 40 dB HL four-frequency pure-tone average [PTA]) of hearing loss bilaterally (since the presence of more than a mild degree of peripheral hearing impairment may impact CAP test results);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Auditory trainingthe study was originally set up so that half of the MS subjects would received auditory training. This intervention has since been discontinued. | Behavioural | MS: Auditory Training |
| MS: Control ActivityMS group not receiving auditory training, doing control activity | Other | MS: Control Activity |
Primary outcome
Electrophysiological Auditory Test
Time frame: Recordings were conducted during one session
auditory P300 amplitude in response to "rare" 1000 Hz tones
2 secondary outcomes
Neural Magnetic Resonance Imaging (MRI)
Time frame: Results were recorded during one scanning session
SCAN-A: Competing Words Test
Time frame: Test administered during one session
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Dennis N. Bourdette, MD principal investigator
VA Portland Health Care System, Portland, OR
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Auditory training in people with Multiple Sclerosis, run by VA Office of Research and Development 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 6 inclusion and 7 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 9 Oct 2018. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 17 Mar 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Electrophysiological Auditory Test (time frame: Recordings were conducted during one session). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Oct 2018.