EpilepsyNCT02749422
fMRI Guided TMS Enhancement of Associative Memory Networks
A study testing MagStim RapidStim2 in people with Epilepsy, run by NYU Langone Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Epilepsy
- What is being tested?
- MagStim RapidStim2
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Oct 2016to 30 Mar 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
New York University School of Medicine
New York, New York, 10016
About this study
Official title: A Randomized Controlled Pilot Study of TMS Enhancement of Associative Memory Networks in Healthy Subjects and Epilepsy Patients
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
- Conditions
- Epilepsy
- Being tested
- MagStim RapidStim2
- Keywords
- cognitive dysfunction, memory loss, non-invasive transcranial magnetic stimulation (TMS), rTMS, Magstim Rapid2
- Medical subject headings
- Epilepsy, Cognitive Dysfunction, Memory Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MagStim RapidStim2Diagnostic test
Repetitive transcranial magnetic stimulation (TMS)
| Study group | Role | What they receive |
|---|---|---|
| Healthy Subjects | Active comparator | Not described Receives: Diagnostic Test: MagStim RapidStim2 |
| Temporal Lobe Epilepsy Patients | Experimental | Not described Receives: Diagnostic Test: MagStim RapidStim2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Immediately before Left Lateral Parietal Site Stimulation, Immediately after Left Lateral Parietal Site Stimulation (20 minute procedure; Up to Week 6)
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.
Measured: Immediately before Motor Cortex Stimulation, Immediately after Motor Cortex Stimulation (20 minute procedure; Up to Week 6)
Secondary outcomes (3)
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.
Measured: Baseline, Week 6
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.
Measured: Immediately before Left Lateral Parietal Site Stimulation, Immediately after Left Lateral Parietal Site Stimulation (20 minute procedure; Up to Week 6)
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.
Measured: Immediately before Motor Cortex Stimulation, Immediately after Motor Cortex Stimulation (20 minute procedure; Up to Week 6)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2016 (estimated)
- Study start14 Oct 2016
- Primary completion30 Mar 2023
- Study completion30 Mar 2023
Why it stopped: This study was closed prematurely due to longer-than-expected recruitment times.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anli Liu, MD, Principal investigator, New York University Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02749422
- Sponsor's protocol ID
- 15-00732
- Status last verified
- May 2024
- First submitted
- 13 Apr 2016
- Last updated
- 29 May 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Pilot Study of TMS Enhancement of Associative Memory Networks in Healthy Subjects and Epilepsy Patients
- ClinicalTrials.gov ID
- NCT02749422
- Acronym / sponsor ID
- 15-00732
- Conditions
- Epilepsy
- Keywords
- cognitive dysfunction, memory loss, non-invasive transcranial magnetic stimulation (TMS), rTMS, Magstim Rapid2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: This study was closed prematurely due to longer-than-expected recruitment times.
- Enrolment
- 8 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 14 Oct 2016 (actual)
- Primary completion
- 30 Mar 2023 (actual)
- Study completion
- 30 Mar 2023 (actual)
- First posted
- 25 Apr 2016 (estimated)
- Results
- Posted 29 May 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy Subjects | Active comparator | Diagnostic Test: MagStim RapidStim2 |
| Temporal Lobe Epilepsy Patients | Experimental | Diagnostic Test: MagStim RapidStim2 |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MagStim RapidStim2Repetitive transcranial magnetic stimulation (TMS) | Diagnostic test | Healthy Subjects, Temporal Lobe Epilepsy Patients |
Primary outcome
Mean Change in Face-Object Pair Association Task Score During Left Lateral Parietal Site Stimulation
Time frame: 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
Time frame: 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.
3 secondary outcomes
Change in fMRI-based Functional Connectivity Between Hippocampus and Cortical Regions
Time frame: Baseline, Week 6
Mean Change in Word-Pair Association Task Score During Left Lateral Parietal Site Stimulation
Time frame: Immediately before Left Lateral Parietal Site Stimulation, Immediately after Left Lateral Parietal Site Stimulation (20 minute procedure; Up to Week 6)
Mean Change in Word-Pair Association Task Score During Motor Cortex Stimulation
Time frame: Immediately before Motor Cortex Stimulation, Immediately after Motor Cortex Stimulation (20 minute procedure; Up to Week 6)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Related trials for Epilepsy
Not yet recruiting
Clinical Trial of SEEG for Drug-resistant Epilepsy
Drug-Resistant Epilepsy
RecruitingPhase 3
Investigate Efficacy and Safety of Carisbamate as Adjunctive Treatment for Seizures Associated With LGS in Children and Adults
Seizures, Lennox Gastaut Syndrome
RecruitingPhase 3
Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures
Focal Seizure, Epilepsy
Active, not recruitingObservational study
Transforming Research and Clinical Knowledge in Traumatic Brain Injury Epileptogenesis Project (TRACK-TBI EPI)
Traumatic Brain Injury, Post-traumatic Epilepsy
RecruitingPhase 3
Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures FOCUS-1
Focal Seizure, Epilepsy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anli Liu, MD principal investigator
New York University Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MagStim RapidStim2 in people with Epilepsy, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 29 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 May 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Change in Face-Object Pair Association Task Score During Left Lateral Parietal Site Stimulation (time frame: Immediately before Left Lateral Parietal Site Stimulation, Immediately after Left Lateral Parietal Site Stimulation (20 minute procedure; Up to Week 6)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2024.