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N/A Completed N=52 Randomized Supportive Care

Effects of Training on Central Auditory Function in Multiple Sclerosis

Source: ClinicalTrials.gov NCT01023074 ↗
Enrolled (actual)
52
Serious AEs
0.0%
Results posted
Mar 2015
Primary outcomePrimary: Electrophysiological Auditory Test — 13.1; 6.4; 6.6 microvolts

Summary

The purpose of this study is to characterize the central auditory processing (CAP) deficits that result from multiple sclerosis (MS).

Outcome Measures

OutcomeResultp-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

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
View full record on ClinicalTrials.gov →

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. Informational only — not medical advice.

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