Trial Outcomes & Findings for Stability of Motor Output in Aging Adults (NCT NCT00970736)
NCT ID: NCT00970736
Last Updated: 2015-04-08
Results Overview
Cortical sites are stimulated sequentially from the SOLMT in the anterior direction. At each site, 5 pulses of 110% of the MEP threshold obtained at the SOLMT are delivered and recorded. If a site produces no MEP in 3/5 pulses it is considered non-submental. This process is continued until the entire submental representation is surrounded by non-submental responsive sites. The number of sites is used to calculate the area of submental representation. The mean sEMG amplitudes of the submental muscles for each of these sites is then calculated for the mean MEP measure.
COMPLETED
20 participants
2 weeks
2015-04-08
Participant Flow
Participant milestones
| Measure |
Healthy Participants
20 healthy participants between 60 and 80 years of age. Ten men and 10 women.
|
|---|---|
|
Overall Study
STARTED
|
20
|
|
Overall Study
COMPLETED
|
18
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Stability of Motor Output in Aging Adults
Baseline characteristics by cohort
| Measure |
Healthy Participants
n=20 Participants
20 healthy participants between 60 and 80 years of age. Ten men and 10 women.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
16 Participants
n=5 Participants
|
|
Age, Continuous
|
68 years
STANDARD_DEVIATION 6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 weeksPopulation: This data was not analyzed because the study funding, as well as PIs VA affiliation, ended prior to any data analyses.
Cortical sites are stimulated sequentially from the SOLMT in the anterior direction. At each site, 5 pulses of 110% of the MEP threshold obtained at the SOLMT are delivered and recorded. If a site produces no MEP in 3/5 pulses it is considered non-submental. This process is continued until the entire submental representation is surrounded by non-submental responsive sites. The number of sites is used to calculate the area of submental representation. The mean sEMG amplitudes of the submental muscles for each of these sites is then calculated for the mean MEP measure.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2 weeksPopulation: This data was not analyzed because the study and funding, as well as the PIs VA affiliation, ended prior to doing any analyses.
Position on the TMS motor map with highest amplitude response to stimulation in the muscles of interest (submental muscles).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2 weeksPopulation: This data was not analyzed because the study, funding, and PIs VA affiliation ended prior to any data analyses.
Cortical sites are stimulated sequentially from the SOLMT in the anterior direction. At each site, 5 pulses of 110% of the MEP threshold obtained at the SOLMT are delivered and recorded. If a site produces no MEP in 3/5 pulses it is considered non-submental. This process is continued until the entire submental representation is surrounded by non-submental responsive sites. The number of sites is used to calculate the area of submental representation.
Outcome measures
Outcome data not reported
Adverse Events
Healthy Participants
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place