Effects of Training on Central Auditory Function in Multiple Sclerosis
Effects of Training on Central Auditory Function in Multiple Sclerosis
What it found
Results are posted in the registry, but without a statistical test of the main measure. See the numbers below.
What was tested
Treatment tested
- Auditory training
Placebo
- MS: Control Activity
Results by group
Electrophysiological Auditory Test
Recordings were conducted during one session
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Arm 1 | 13.1 microvolts | 6.7 (Standard Deviation) | 26 |
| Arm 2 | 6.4 microvolts | 4 (Standard Deviation) | 13 |
| Arm 3 | 6.6 microvolts | 4.4 (Standard Deviation) | 13 |
Arm 1
Arm 2
Arm 3
Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.
Safety
| Group | Participants at risk | Serious adverse events | Deaths |
|---|---|---|---|
| Non-MS Control | 26 | 0 (0.0%) | |
| MS: Auditory Training | 13 | 0 (0.0%) | |
| MS: Control Activity | 13 | 0 (0.0%) |
As posted on ClinicalTrials.gov. Serious adverse events include any serious health event during the trial, whether or not the treatment caused it.
What it measured
Main measures
Electrophysiological Auditory Test
Recordings were conducted during one session
Other measures (2)
Neural Magnetic Resonance Imaging (MRI)
Results were recorded during one scanning session
MRI lesionsBrain volume lossSCAN-A: Competing Words Test
Test administered during one session
Who could take part
Relapsing and progressive · 21 to 65 · EDSS 0 to 7.0
Show the full 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
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
The purpose of this study is to characterize the central auditory processing (CAP) deficits that result from multiple sclerosis (MS).
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History
Started
Oct 2007
Main results due
Jun 2011
Finished
Jun 2011
Results posted
Mar 2015