Trial Outcomes & Findings for DESIPHER_Speech Degradation as an Indicator of Physiological Degeneration in ALS (NCT NCT02675075)
NCT ID: NCT02675075
Last Updated: 2020-08-18
Results Overview
Forced Vital Capacity (FVC) measures the ability of the lung to move air. The change in FVC was calculated from the initial time point to either the end of study (24 months) or to final visit due to either death or loss to followup.
Recruitment status
COMPLETED
Target enrollment
34 participants
Primary outcome timeframe
Baseline, and every 3 months up to 24 months
Results posted on
2020-08-18
Participant Flow
Subjects were recruited from the amyotrophic lateral sclerosis (ALS) Clinic at the James A. Haley Hospital from January 2016 to November 2017
Participant milestones
| Measure |
Veterans With ALS
This Cohort Study will admit all eligible, interested Veterans diagnosed with ALS who meet the inclusion criteria.
|
Healthy Controls
Anonymous Controls who were not diagnosed with any nervous system diseases.
|
|---|---|---|
|
Overall Study
STARTED
|
15
|
19
|
|
Overall Study
COMPLETED
|
12
|
19
|
|
Overall Study
NOT COMPLETED
|
3
|
0
|
Reasons for withdrawal
| Measure |
Veterans With ALS
This Cohort Study will admit all eligible, interested Veterans diagnosed with ALS who meet the inclusion criteria.
|
Healthy Controls
Anonymous Controls who were not diagnosed with any nervous system diseases.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
3
|
0
|
Baseline Characteristics
Healthy controls were only service as baseline for Vocal recordings to minimize burden on the subjects. Tongue strength was only collected for the ALS arm.
Baseline characteristics by cohort
| Measure |
Veterans With ALS
n=15 Participants
This Cohort Study will admit all eligible, interested Veterans diagnosed with ALS who meet the inclusion criteria. Veterans were at least 18 years old, and were diagnosed with ALS, and followed at the James A Haley VA Hospital
|
Healthy Controls
n=19 Participants
Healthy Controls were recruited to complete a one time vocal recording of the TIMIT and Ba repetition voice recordings.
|
Total
n=34 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=15 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=34 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
8 Participants
n=15 Participants
|
14 Participants
n=19 Participants
|
22 Participants
n=34 Participants
|
|
Age, Categorical
>=65 years
|
7 Participants
n=15 Participants
|
5 Participants
n=19 Participants
|
12 Participants
n=34 Participants
|
|
Age, Continuous
|
63.4 years
STANDARD_DEVIATION 10.8 • n=15 Participants
|
53.3 years
STANDARD_DEVIATION 11.2 • n=19 Participants
|
57.8 years
STANDARD_DEVIATION 11.6 • n=34 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=15 Participants
|
12 Participants
n=19 Participants
|
13 Participants
n=34 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=15 Participants
|
7 Participants
n=19 Participants
|
21 Participants
n=34 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=15 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=34 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=15 Participants
|
2 Participants
n=19 Participants
|
3 Participants
n=34 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=15 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=34 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=15 Participants
|
1 Participants
n=19 Participants
|
2 Participants
n=34 Participants
|
|
Race (NIH/OMB)
White
|
13 Participants
n=15 Participants
|
16 Participants
n=19 Participants
|
29 Participants
n=34 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=15 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=34 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=15 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=34 Participants
|
|
Tongue Strength
|
31.6 KPa
STANDARD_DEVIATION 17.2 • n=15 Participants • Healthy controls were only service as baseline for Vocal recordings to minimize burden on the subjects. Tongue strength was only collected for the ALS arm.
|
—
|
31.6 KPa
STANDARD_DEVIATION 17.2 • n=15 Participants • Healthy controls were only service as baseline for Vocal recordings to minimize burden on the subjects. Tongue strength was only collected for the ALS arm.
|
|
Lip Strength
|
15.5 kPa
STANDARD_DEVIATION 9.0 • n=15 Participants • Healthy Controls were only serving as baseline for vocal recordings. Lip strength was only collected for the ALS ARM.
|
—
|
15.5 kPa
STANDARD_DEVIATION 9.0 • n=15 Participants • Healthy Controls were only serving as baseline for vocal recordings. Lip strength was only collected for the ALS ARM.
|
|
Percent of Predicted Forced Vital Capacity (FVC)
|
69.1 Expected % Max FVC
STANDARD_DEVIATION 21.9 • n=15 Participants • Healthy controls only participated in vocal recording to minimize burden. This measurement was only taken for the ALS Arm of the study.
|
—
|
69.1 Expected % Max FVC
STANDARD_DEVIATION 21.9 • n=15 Participants • Healthy controls only participated in vocal recording to minimize burden. This measurement was only taken for the ALS Arm of the study.
|
|
Speech Intelligence Test
|
98.6 Percent words Intellegible
STANDARD_DEVIATION 4.5 • n=15 Participants • Healthy controls only participated in the Vocal recordings to minimize subject burden. This measurement was only collected for the ALS arm of the study.
|
—
|
98.6 Percent words Intellegible
STANDARD_DEVIATION 4.5 • n=15 Participants • Healthy controls only participated in the Vocal recordings to minimize subject burden. This measurement was only collected for the ALS arm of the study.
|
|
ALS Functional Ratings Scale-Revised
|
32.5 units Standardized Outcome Measu
STANDARD_DEVIATION 7.4 • n=15 Participants • Healthy controls only participated in the Vocal recordings to minimize subject burden. This measurement was only collected for the ALS arm of the study.
|
—
|
32.5 units Standardized Outcome Measu
STANDARD_DEVIATION 7.4 • n=15 Participants • Healthy controls only participated in the Vocal recordings to minimize subject burden. This measurement was only collected for the ALS arm of the study.
|
PRIMARY outcome
Timeframe: Baseline, and every 3 months up to 24 monthsPopulation: Data for this measure were not collected for healthy controls.
Forced Vital Capacity (FVC) measures the ability of the lung to move air. The change in FVC was calculated from the initial time point to either the end of study (24 months) or to final visit due to either death or loss to followup.
Outcome measures
| Measure |
Veterans With ALS
n=9 Participants
This Cohort Study will admit all eligible, interested Veterans diagnosed with ALS who meet the inclusion criteria.
|
Healthy Controls
Anonymous Controls who were not diagnosed with any nervous system diseases.
|
|---|---|---|
|
Change in Percent of Expected Lung Force Vital Capacity
|
-1.25 % Expected Forced Vital Capacity
Standard Deviation 7.05
|
—
|
SECONDARY outcome
Timeframe: Baseline, 3 Month intervals up to 24 months, calculated from the initial time point to either the end of study (24 months) or to final visit due to either death or loss to followupPopulation: Data for this measurement was only collected on the Veterans with ALS Arm. Data for this measure were not collected for healthy controls.
A physiological measurement of tongue muscle strength, in multiple directions. A force measured with Iowa Oral Performance Instrument (IOPI)
Outcome measures
| Measure |
Veterans With ALS
n=9 Participants
This Cohort Study will admit all eligible, interested Veterans diagnosed with ALS who meet the inclusion criteria.
|
Healthy Controls
Anonymous Controls who were not diagnosed with any nervous system diseases.
|
|---|---|---|
|
Change in Tongue Strength
|
-.625 kPa
Standard Deviation 5.45
|
—
|
SECONDARY outcome
Timeframe: Baseline, 3 Month intervals up to 24 months, calculated from the initial time point to either the end of study (24 months) or to final visit due to either death or loss to followupPopulation: Speech Divergence is a novel calculated measure for this study based on change in vocal characteristics of 13 characteristics. Speech Divergence was not collected for the Healthy Controls.
A measure looking at changes in vocal characteristics away from standard language. Speech Divergence is a novel calculated measure based on identifying changes to 13 characteristics of speech. The score can range from 0-13. Zero would represent normal speech, while 13 would be distorted speech along all parameters.
Outcome measures
| Measure |
Veterans With ALS
n=9 Participants
This Cohort Study will admit all eligible, interested Veterans diagnosed with ALS who meet the inclusion criteria.
|
Healthy Controls
Anonymous Controls who were not diagnosed with any nervous system diseases.
|
|---|---|---|
|
Change in Speech - as Measured by Speech Divergence
|
1.88 score on a scale
Standard Deviation 1.40
|
—
|
Adverse Events
Veterans With ALS
Serious events: 4 serious events
Other events: 0 other events
Deaths: 3 deaths
Healthy Controls
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Veterans With ALS
n=15 participants at risk
This Cohort Study will admit all eligible, interested Veterans diagnosed with ALS who meet the inclusion criteria.
|
Healthy Controls
n=19 participants at risk
Healthy Controls were enrolled for a one time vocal recording. There was no follow-up visits for healthy controls.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Tracheostomy
|
6.7%
1/15 • Number of events 1 • Adverse Event Data was monitored from time of enrollment to end of study, loss to follow-up or death up to two years.
|
0.00%
0/19 • Adverse Event Data was monitored from time of enrollment to end of study, loss to follow-up or death up to two years.
|
|
Respiratory, thoracic and mediastinal disorders
Death due to progression of ALS
|
20.0%
3/15 • Number of events 3 • Adverse Event Data was monitored from time of enrollment to end of study, loss to follow-up or death up to two years.
|
0.00%
0/19 • Adverse Event Data was monitored from time of enrollment to end of study, loss to follow-up or death up to two years.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place