Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Effects of Training on Central Auditory Function in Multiple Sclerosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01023074
Recruitment Status : Completed
First Posted : December 2, 2009
Results First Posted : March 17, 2015
Last Update Posted : October 9, 2018
Sponsor:
Collaborator:
Oregon Health and Science University
Information provided by (Responsible Party):
VA Office of Research and Development

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Supportive Care
Condition Multiple Sclerosis
Interventions Behavioral: Auditory training
Other: MS: Control Activity
Enrollment 52
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Non-MS Control MS: Auditory Training MS: Control Activity
Hide Arm/Group Description Non-MS control group

MS group receiving auditory training

Auditory training: the study was originally set up so that half of the MS subjects would received auditory training. This intervention has since been discontinued.

MS group not receiving auditory training, doing control activity

Auditory training: the study was originally set up so that half of the MS subjects would received auditory training. This intervention has since been discontinued.

Period Title: Overall Study
Started 26 13 13
Completed 26 13 13
Not Completed 0 0 0
Arm/Group Title Non-MS Control MS:Auditory Training MS: Control Activity Total
Hide Arm/Group Description Non-MS control group

MS group receiving auditory training

Auditory training: the study was originally set up so that half of the MS subjects would received auditory training. This intervention has since been discontinued.

MS group not receiving auditory training, doing control activity

Auditory training: the study was originally set up so that half of the MS subjects would received auditory training. This intervention has since been discontinued.

Total of all reporting groups
Overall Number of Baseline Participants 26 13 13 52
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 26 participants 13 participants 13 participants 52 participants
43.2  (12.5) 52.0  (9.6) 53.0  (10) 47.85  (11.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 26 participants 13 participants 13 participants 52 participants
Female
15
  57.7%
10
  76.9%
10
  76.9%
35
  67.3%
Male
11
  42.3%
3
  23.1%
3
  23.1%
17
  32.7%
1.Primary Outcome
Title Electrophysiological Auditory Test
Hide Description auditory P300 amplitude in response to "rare" 1000 Hz tones
Time Frame Recordings were conducted during one session
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm 1 Arm 2 Arm 3
Hide Arm/Group Description:
Non-MS control group

MS group receiving auditory training

Auditory training: the study was originally set up so that half of the MS subjects would received auditory training. This intervention has since been discontinued.

MS group not receiving auditory training, doing control activity

Auditory training: the study was originally set up so that half of the MS subjects would received auditory training. This intervention has since been discontinued.

Overall Number of Participants Analyzed 26 13 13
Mean (Standard Deviation)
Unit of Measure: microvolts
13.1  (6.7) 6.4  (4.0) 6.6  (4.4)
2.Secondary Outcome
Title Neural Magnetic Resonance Imaging (MRI)
Hide Description Gray matter volume
Time Frame Results were recorded during one scanning session
Hide Outcome Measure Data
Hide Analysis Population Description
Data reported for 47 study participants who underwent MRI
Arm/Group Title Non-MS Control MS: Auditory Training MS: Control Activity
Hide Arm/Group Description:
Non-MS control group

MS group receiving auditory training

Auditory training: the study was originally set up so that half of the MS subjects would received auditory training. This intervention has since been discontinued.

MS group not receiving auditory training, doing control activity
Overall Number of Participants Analyzed 21 13 13
Mean (Standard Deviation)
Unit of Measure: cubic cm
1065  (17) 990  (22) 990  (22)
3.Secondary Outcome
Title SCAN-A: Competing Words Test
Hide Description 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.
Time Frame Test administered during one session
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Non-MS Control MS: Auditory Training MS: Control Activity
Hide Arm/Group Description:
Non-MS control group

MS group receiving auditory training

Auditory training: the study was originally set up so that half of the MS subjects would received auditory training. This intervention has since been discontinued.

MS group not receiving auditory training, doing control activity

Auditory training: the study was originally set up so that half of the MS subjects would received auditory training. This intervention has since been discontinued.

Overall Number of Participants Analyzed 26 13 13
Mean (Standard Deviation)
Unit of Measure: units on a scale
10.5  (2.2) 7.5  (3.7) 7.5  (3.7)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Non-MS Control MS: Auditory Training MS: Control Activity
Hide Arm/Group Description Non-MS control group

MS group receiving auditory training

Auditory training: the study was originally set up so that half of the MS subjects would received auditory training. This intervention has since been discontinued.

MS group not receiving auditory training, doing control activity

Auditory training: the study was originally set up so that half of the MS subjects would received auditory training. This intervention has since been discontinued.

All-Cause Mortality
Non-MS Control MS: Auditory Training MS: Control Activity
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Non-MS Control MS: Auditory Training MS: Control Activity
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/26 (0.00%)   0/13 (0.00%)   0/13 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Non-MS Control MS: Auditory Training MS: Control Activity
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/26 (0.00%)   0/13 (0.00%)   0/13 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Robert Folmer, Ph.D.
Organization: Portland VA Medical Center
Phone: 503-220-8262 ext 51868
EMail: Robert.Folmer@va.gov
Layout table for additonal information
Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT01023074     History of Changes
Other Study ID Numbers: B4762-R
NCRAR-VA-04-1205 ( Other Identifier: Portland VA Medical Center IRB )
OHSU - 3188 ( Other Identifier: Oregon Health Sciences University IRB )
First Submitted: November 30, 2009
First Posted: December 2, 2009
Results First Submitted: January 29, 2015
Results First Posted: March 17, 2015
Last Update Posted: October 9, 2018