Trial Outcomes & Findings for fMRI Guided TMS Enhancement of Associative Memory Networks (NCT NCT02749422)

NCT ID: NCT02749422

Last Updated: 2024-05-29

Results Overview

A face-object pair association task will be administered before and after rTMS treatment at each treatment session. This measure is evaluating the mean change in the task score from immediately before rTMS is applied to the left lateral parietal site to immediately after treatment.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

8 participants

Primary outcome timeframe

Immediately before Left Lateral Parietal Site Stimulation, Immediately after Left Lateral Parietal Site Stimulation (20 minute procedure; Up to Week 6)

Results posted on

2024-05-29

Participant Flow

No patients were enrolled in the Healthy Subjects arm.

Participant milestones

Participant milestones
Measure
Healthy Subjects
MagStim RapidStim2: Repetitive transcranial magnetic stimulation (TMS)
Temporal Lobe Epilepsy Patients
MagStim RapidStim2: Repetitive transcranial magnetic stimulation (TMS)
Overall Study
STARTED
0
8
Overall Study
COMPLETED
0
5
Overall Study
NOT COMPLETED
0
3

Reasons for withdrawal

Reasons for withdrawal
Measure
Healthy Subjects
MagStim RapidStim2: Repetitive transcranial magnetic stimulation (TMS)
Temporal Lobe Epilepsy Patients
MagStim RapidStim2: Repetitive transcranial magnetic stimulation (TMS)
Overall Study
Lost to Follow-up
0
2
Overall Study
Ineligible
0
1

Baseline Characteristics

fMRI Guided TMS Enhancement of Associative Memory Networks

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Healthy Subjects
MagStim RapidStim2: Repetitive transcranial magnetic stimulation (TMS)
Temporal Lobe Epilepsy Patients
n=5 Participants
MagStim RapidStim2: Repetitive transcranial magnetic stimulation (TMS)
Total
n=5 Participants
Total of all reporting groups
Age, Continuous
26.6 years
STANDARD_DEVIATION 7.3 • n=7 Participants
26.6 years
STANDARD_DEVIATION 7.3 • n=5 Participants
Sex: Female, Male
Female
4 Participants
n=7 Participants
4 Participants
n=5 Participants
Sex: Female, Male
Male
1 Participants
n=7 Participants
1 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
1 Participants
n=7 Participants
1 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
4 Participants
n=7 Participants
4 Participants
n=5 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
Asian
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
Black or African American
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
White
1 Participants
n=7 Participants
1 Participants
n=5 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
Unknown or Not Reported
4 Participants
n=7 Participants
4 Participants
n=5 Participants
Region of Enrollment
United States
5 participants
n=7 Participants
5 participants
n=5 Participants

PRIMARY outcome

Timeframe: Immediately before Left Lateral Parietal Site Stimulation, Immediately after Left Lateral Parietal Site Stimulation (20 minute procedure; Up to Week 6)

Population: Data for this outcome measure were not collected from participants in the study.

A face-object pair association task will be administered before and after rTMS treatment at each treatment session. This measure is evaluating the mean change in the task score from immediately before rTMS is applied to the left lateral parietal site to immediately after treatment.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Immediately before Motor Cortex Stimulation, Immediately after Motor Cortex Stimulation (20 minute procedure; Up to Week 6)

Population: Data for this outcome measure were not collected from participants in the study.

A face-object pair association task will be administered before and after rTMS treatment at each treatment session. This measure is evaluating the mean change in the task score from immediately before rTMS is applied to the motor cortex to immediately after treatment.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, Week 6

Population: Data for this outcome measure were not collected from participants in the study.

Changes in hippocampal-cortical functional connectivity will be identified using voxel-wise paired T-tests. The change will be measured between baseline assessment and resting state fMRI assessment following rTMS.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Immediately before Left Lateral Parietal Site Stimulation, Immediately after Left Lateral Parietal Site Stimulation (20 minute procedure; Up to Week 6)

Population: Data for this outcome measure were not collected from participants in the study.

A word-pair association task will be administered before and after rTMS treatment at each treatment session. This measure is evaluating the mean change in the task score from immediately before rTMS is applied to the left lateral parietal site to immediately after treatment.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Immediately before Motor Cortex Stimulation, Immediately after Motor Cortex Stimulation (20 minute procedure; Up to Week 6)

Population: Data for this outcome measure were not collected from participants in the study.

A word-pair association task will be administered before and after rTMS treatment at each treatment session. This measure is evaluating the mean change in the task score from immediately before rTMS is applied to the motor cortex to immediately after treatment.

Outcome measures

Outcome data not reported

Adverse Events

Healthy Subjects

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Temporal Lobe Epilepsy Patients

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

Anli Liu

NYU Langone Health

Phone: 929-455-2340

Results disclosure agreements

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