Epilepsy
Conditions
Keywords
cognitive dysfunction, memory loss, non-invasive transcranial magnetic stimulation (TMS), rTMS, Magstim Rapid2
Brief summary
This is a randomized, single-blinded, controlled phase 1 study to demonstrate feasibility and explore the neurophysiologic and clinical effects of repetitive transcranial magnetic stimulation (TMS) interventions in epilepsy patients and healthy controls. The inclusion of a control group will be used to see whether epilepsy patients, who suffer from a higher degree of comorbid memory difficulty presumably from entorhinal-hippocampal dysfunction, can benefit from a TMS intervention can benefit as much as a healthy matched population. Investigators will also be looking at functional connectivity between the hippocampus and cortical regions
Interventions
DIAGNOSTIC_TESTMagStim RapidStim2
Repetitive transcranial magnetic stimulation (TMS)
Sponsors
NYU Langone Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
* Fluent in English * Right-handed * Score at least 26 out of 30 on the Montreal Cognitive Assessment (MOCA). Healthy subjects will be matched to age, handedness, and education compared to epilepsy subjects. * Must be able to provide informed consent.
Exclusion criteria
* Any history of a neurological disorder * Chronic or progressive medical condition * Any history of severe traumatic brain injury or skull defect * Metal or devices in the head, including neurostimulators of metal foreign bodies * Any other implanted metal device, including pacemaker, spinal cord stimulator, VNS. * Any other ferromagnetic substance in the body (including tattoos, dental prosthetics, etc). * Taking a medication which may lower the seizure threshold within the 4 weeks prior to the start of the study, including use of neuroleptic (esp. clozapine), antibiotic (penicillin, cephalosporins), and bronchodilating medications. * Pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change in Face-Object Pair Association Task Score During Left Lateral Parietal Site Stimulation | Immediately before Left Lateral Parietal Site Stimulation, Immediately after Left Lateral Parietal Site Stimulation (20 minute procedure; Up to Week 6) | 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. |
| Mean Change in Face-Object Pair Association Task Score During Motor Cortex Stimulation | Immediately before Motor Cortex Stimulation, Immediately after Motor Cortex Stimulation (20 minute procedure; Up to Week 6) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in fMRI-based Functional Connectivity Between Hippocampus and Cortical Regions | Baseline, Week 6 | 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. |
| Mean Change in Word-Pair Association Task Score During Left Lateral Parietal Site Stimulation | Immediately before Left Lateral Parietal Site Stimulation, Immediately after Left Lateral Parietal Site Stimulation (20 minute procedure; Up to Week 6) | 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. |
| Mean Change in Word-Pair Association Task Score During Motor Cortex Stimulation | Immediately before Motor Cortex Stimulation, Immediately after Motor Cortex Stimulation (20 minute procedure; Up to Week 6) | 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. |
Countries
United States
Participant flow
Pre-assignment details
No patients were enrolled in the Healthy Subjects arm.
Participants by arm
| Arm | Count |
|---|---|
| Healthy Subjects MagStim RapidStim2: Repetitive transcranial magnetic stimulation (TMS) | 0 |
| Temporal Lobe Epilepsy Patients MagStim RapidStim2: Repetitive transcranial magnetic stimulation (TMS) | 5 |
| Total | 5 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Ineligible | 0 | 1 |
| Overall Study | Lost to Follow-up | 0 | 2 |
Baseline characteristics
| Characteristic | Temporal Lobe Epilepsy Patients | Total |
|---|---|---|
| Age, Continuous | 26.6 years STANDARD_DEVIATION 7.3 | 26.6 years STANDARD_DEVIATION 7.3 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 1 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 4 Participants | 4 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 4 Participants | 4 Participants |
| Race (NIH/OMB) White | 1 Participants | 1 Participants |
| Region of Enrollment United States | 5 participants | 5 participants |
| Sex: Female, Male Female | 4 Participants | 4 Participants |
| Sex: Female, Male Male | 1 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 5 |
| other Total, other adverse events | 0 / 0 | 0 / 5 |
| serious Total, serious adverse events | 0 / 0 | 0 / 5 |
Outcome results
Primary
Mean Change in Face-Object Pair Association Task Score During Left Lateral Parietal Site Stimulation
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.
Time frame: 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.
Primary
Mean Change in Face-Object Pair Association Task Score During Motor Cortex Stimulation
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.
Time frame: 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.
Secondary
Change in fMRI-based Functional Connectivity Between Hippocampus and Cortical Regions
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.
Time frame: Baseline, Week 6
Population: Data for this outcome measure were not collected from participants in the study.
Secondary
Mean Change in Word-Pair Association Task Score During Left Lateral Parietal Site Stimulation
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.
Time frame: 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.
Secondary
Mean Change in Word-Pair Association Task Score During Motor Cortex Stimulation
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.
Time frame: 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.