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Trial record 36 of 38 for:    alternans

Repeated TMS at Low Frequencies to Reduce Seizure Occurrence

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ClinicalTrials.gov Identifier: NCT03154307
Recruitment Status : Recruiting
First Posted : May 16, 2017
Last Update Posted : May 16, 2017
Sponsor:
Collaborators:
U.S. National Science Foundation
Florida International University
Information provided by (Responsible Party):
Alberto Pinzon, Baptist Health South Florida

Brief Summary:
Perform non-invasive neuro-navigated repeated Transcranial Magnetic Stimulation (rTMS) at low frequencies (LF) with the intent to reduce the occurrence of seizures over time. Seizure reduction and improvements in the quality of life in patients with epilepsy will be associated with increased cortical inhibition resulting from the LF-rTMS sessions over time. This procedure using rTMS at low frequencies (LF-rTMS) between 0.5 and 1 Hz is a safe and painless method for noninvasive focal cortical brain stimulation, which will be evaluated in its efficacy at reducing/suppressing seizures. Accordingly, we propose a clinical trial in patients with epilepsy to test whether LF-rTMS can improve seizure suppression. The location of the presumed 3D source in the brain will be stimulated for few minutes (10 to 15 min.). With the same rTMS modality, we will also perform motor threshold mapping in conjunction with its fully integrated and compatible electroencephalography (EEG) module. Up to 100 individuals 18 to 80 years with epilepsy will be enrolled.

Condition or disease Intervention/treatment Phase
Epilepsy Device: Low frequency repeated TMS (LF-rTMS) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Repeated TMS at Low Frequencies to Reduce Seizure Occurrence
Actual Study Start Date : May 10, 2017
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy Seizures

Arm Intervention/treatment
Experimental: Group 1: Weekly TMS
LF-rTMS intervention for 2 weeks (5 days per week for total of 10 days) , LF-rTMS 1 session/week for 1 month (4 days), and LF-rTMS 1 session/month for 11 months
Device: Low frequency repeated TMS (LF-rTMS)
Each patient will then begin treatment with 14 minute sessions of 1 Hz rTMS or sham rTMS, 120% minimum threshold (MT), and 800 stimuli on the position of the calculated 3D source using EEG, MRI, and digitized electrode locations. Two different timelines of delivering the rTMS will be compared against a sham/delayed treatment group.

Experimental: Group 2: Monthly TMS
LF-rTMS intervention for 2 weeks (5 days per week for total of 10 days), LF-rTMS 1 session/month for 12 months
Device: Low frequency repeated TMS (LF-rTMS)
Each patient will then begin treatment with 14 minute sessions of 1 Hz rTMS or sham rTMS, 120% minimum threshold (MT), and 800 stimuli on the position of the calculated 3D source using EEG, MRI, and digitized electrode locations. Two different timelines of delivering the rTMS will be compared against a sham/delayed treatment group.

Sham Comparator: Group 3: Sham TMS
Sham LF-rTMS for 2 weeks (5 days per week for a total of 10 days), sham LF-rTMS 1 session/week for 1 month (4 days), and sham LF-rTMS 1 session/month for 1 month. After the sham stimulation real LF-rTMS intervention sessions will be delivered as follows: 50% of placebo group will follow group 1 protocol and the other 50% will follow group 2 protocol
Device: Low frequency repeated TMS (LF-rTMS)
Each patient will then begin treatment with 14 minute sessions of 1 Hz rTMS or sham rTMS, 120% minimum threshold (MT), and 800 stimuli on the position of the calculated 3D source using EEG, MRI, and digitized electrode locations. Two different timelines of delivering the rTMS will be compared against a sham/delayed treatment group.




Primary Outcome Measures :
  1. Average weekly seizure frequency [ Time Frame: From baseline to study completion, approx. 1 year ]
    The baseline seizure frequency and seizure frequency change after treatment will be computed from average weekly seizure frequencies before and after rTMS treatment for each patient.


Secondary Outcome Measures :
  1. Scalp EEG time and frequency domain parameters [ Time Frame: From baseline to study completion, approx. 1 year ]
    Scalp EEG s in order to extract time and frequency domain parameters to assess the reaction of the brain to magnetic stimulation using different intensities and frequencies.

  2. ECG signals [ Time Frame: From baseline to study completion, approx. 1 year ]
    To obtain the heart rate frequency and to calculate the QT dispersion ratio, and T- alternans

  3. Electromyography (EMG) data [ Time Frame: From baseline to study completion, approx. 1 year ]
    To monitor different muscle groups

  4. DICOM stimulation maps [ Time Frame: From baseline to study completion, approx. 1 year ]
    To determine motor threshold maps



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Experience ≥ 3 seizures/month in the month prior to starting study (any type of seizure will count)
  • No status epilepticus in the last 12 months
  • No change in medication in last 30 days

Exclusion Criteria:

  • Presence of implanted electronic devices (e.g., pacemaker, medication pump, brain or vagus nerve stimulator, cochlear implant)
  • Presence of intracranial metal (e.g., aneurysm clip)
  • Unable to cooperate with non-sedated, navigated TMS testing

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03154307


Contacts
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Contact: Amy K Starosciak, Ph.D. (786) 596-1825 amyst@baptisthealth.net

Locations
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United States, Florida
Baptist Hospital of Miami Recruiting
Miami, Florida, United States, 33176
Sponsors and Collaborators
Baptist Health South Florida
U.S. National Science Foundation
Florida International University
Investigators
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Principal Investigator: Alberto Pinzon, M.D., Ph.D. Baptist Health South Florida

Publications:
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Responsible Party: Alberto Pinzon, Neurologist, Medical Director, Baptist Health Epilepsy Program, Baptist Health South Florida
ClinicalTrials.gov Identifier: NCT03154307     History of Changes
Other Study ID Numbers: 15-135
First Posted: May 16, 2017    Key Record Dates
Last Update Posted: May 16, 2017
Last Verified: May 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Additional relevant MeSH terms:
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Seizures
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms