N/A
N=52
Effects of Training on Central Auditory Function in Multiple Sclerosis
Multiple Sclerosis
Bottom Line
View on ClinicalTrials.gov: NCT01023074 ↗Enrolled (actual)
52
Serious AEs
0.0%
Results posted
Mar 2015
Primary outcome: Primary: Electrophysiological Auditory Test — 13.1; 6.4; 6.6 microvolts
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Auditory training (Behavioral); MS: Control Activity (Other)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- Jun 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Electrophysiological Auditory Test |
13.1; 6.4; 6.6 | — |
| SECONDARY Neural Magnetic Resonance Imaging (MRI) |
1065; 990; 990 | — |
| SECONDARY SCAN-A: Competing Words Test |
10.5; 7.5; 7.5 | — |
Summary
The purpose of this study is to characterize the central auditory processing (CAP) deficits that result from multiple sclerosis (MS).
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT01023074). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.