Trial Outcomes & Findings for Effects of Training on Central Auditory Function in Multiple Sclerosis (NCT NCT01023074)

NCT ID: NCT01023074

Last Updated: 2018-10-09

Results Overview

auditory P300 amplitude in response to "rare" 1000 Hz tones

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 52 participants
• Primary outcome timeframe: Recordings were conducted during one session
• Results posted on: 2018-10-09

Participant Flow

Participant milestones

Measure	Non-MS Control Non-MS control group	MS: Auditory Training 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: Control Activity 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 Study STARTED	26	13	13
Overall Study COMPLETED	26	13	13
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effects of Training on Central Auditory Function in Multiple Sclerosis

Baseline characteristics by cohort

Measure	Non-MS Control n=26 Participants Non-MS control group	MS:Auditory Training n=13 Participants 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: Control Activity n=13 Participants 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 n=52 Participants Total of all reporting groups
Age, Continuous	43.2 years STANDARD_DEVIATION 12.5 • n=5 Participants	52.0 years STANDARD_DEVIATION 9.6 • n=7 Participants	53.0 years STANDARD_DEVIATION 10 • n=5 Participants	47.85 years STANDARD_DEVIATION 11.1 • n=4 Participants
Sex: Female, Male Female	15 Participants n=5 Participants	10 Participants n=7 Participants	10 Participants n=5 Participants	35 Participants n=4 Participants
Sex: Female, Male Male	11 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants	17 Participants n=4 Participants

PRIMARY outcome

Timeframe: Recordings were conducted during one session

auditory P300 amplitude in response to "rare" 1000 Hz tones

Outcome measures

Measure	Arm 1 n=26 Participants Non-MS control group	Arm 2 n=13 Participants 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.	Arm 3 n=13 Participants 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.
Electrophysiological Auditory Test	13.1 microvolts Standard Deviation 6.7	6.4 microvolts Standard Deviation 4.0	6.6 microvolts Standard Deviation 4.4

SECONDARY outcome

Timeframe: Results were recorded during one scanning session

Population: Data reported for 47 study participants who underwent MRI

Gray matter volume

Outcome measures

Measure	Arm 1 n=21 Participants Non-MS control group	Arm 2 n=13 Participants 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.	Arm 3 n=13 Participants 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.
Neural Magnetic Resonance Imaging (MRI)	1065 cubic cm Standard Deviation 17	990 cubic cm Standard Deviation 22	990 cubic cm Standard Deviation 22

SECONDARY outcome

Timeframe: Test administered during one session

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.

Outcome measures

Measure	Arm 1 n=26 Participants Non-MS control group	Arm 2 n=13 Participants 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.	Arm 3 n=13 Participants 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.
SCAN-A: Competing Words Test	10.5 units on a scale Standard Deviation 2.2	7.5 units on a scale Standard Deviation 3.7	7.5 units on a scale Standard Deviation 3.7

Adverse Events

Non-MS Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

MS: Auditory Training

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

MS: Control Activity

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Robert Folmer, Ph.D.

Portland VA Medical Center

Phone: 503-220-8262

Email: Robert.Folmer@va.gov

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place