Trial Outcomes & Findings for Using fMRI-guided TMS to Increase Central Executive Function in Older Adults (MCI_Sub) (NCT NCT04176406)
NCT ID: NCT04176406
Last Updated: 2021-01-27
Results Overview
Accuracy (in percentage) will be assessed to evaluate the acute effect of rTMS.
TERMINATED
NA
10 participants
Through study completion, an average of one year
2021-01-27
Participant Flow
Study was terminated prior to application of rTMS or Sham.
Participant milestones
| Measure |
rTMS Over a Node Within the Fronto-parietal Network
excitatory 5Hz rTMS will be applied over a node within the fronto-parietal network, defined via network analysis.
rTMS: excitatory 5Hz rTMS will be used
|
Sham rTMS Over a Node Within the Fronto-parietal Network
electrical sham coil applied over a node within the fronto-parietal network.
Sham rTMS: an electrical sham coil reproducing the same clicking sound and tactile sensation than the active rTMS will be used
|
rTMS Over the DLPFC
excitatory 5Hz rTMS will be applied over the dorso-lateral prefrontal cortex showing the strongest fMRI activation.
rTMS: excitatory 5Hz rTMS will be used
|
Sham rTMS Over the DLPFC
electrical sham coil applied over the DLPFC.
Sham rTMS: an electrical sham coil reproducing the same clicking sound and tactile sensation than the active rTMS will be used
|
|---|---|---|---|---|
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Overall Study
STARTED
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0
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0
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0
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0
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Overall Study
COMPLETED
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0
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0
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0
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0
|
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Overall Study
NOT COMPLETED
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0
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0
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0
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Using fMRI-guided TMS to Increase Central Executive Function in Older Adults (MCI_Sub)
Baseline characteristics by cohort
| Measure |
Enrolled Participants
n=10 Participants
The following numbers represent the baseline characteristics for the participants enrolled in the study, who performed only the behavioral task. None of these participants received rTMS
|
|---|---|
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Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
7 Participants
n=5 Participants
|
|
Age, Continuous
|
65.2 years
STANDARD_DEVIATION 6.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
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Region of Enrollment
United States
|
10 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Through study completion, an average of one yearPopulation: The study had to be interrupted because of Covid-19 situation, while we were still piloting the behavioral task. Therefore no data with rTMS were collected.
Accuracy (in percentage) will be assessed to evaluate the acute effect of rTMS.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Through study completion an average of one yearPopulation: The study had be be terminated early due to the Covid-19 situation, while we were still piloting the behavioral task. Therefore no participants received rTMS
Reaction times (in ms) will be assessed to evaluate the acute effect of rTMS
Outcome measures
Outcome data not reported
Adverse Events
rTMS Over a Node Within the Fronto-parietal Network
Sham rTMS Over a Node Within the Fronto-parietal Network
rTMS Over the DLPFC
Sham rTMS Over the DLPFC
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