Repeated TMS at Low Frequencies to Reduce Seizure Occurrence

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Brief Title

Repeated TMS at Low Frequencies to Reduce Seizure Occurrence

Official Title

Repeated TMS at Low Frequencies to Reduce Seizure Occurrence

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 (long-term
      protocol). 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.

      In addition, a short-term protocol has been added to test whether LF-rTMS can reduce or
      suppress status epilepticus in medically refractory participants.
    

Detailed Description

      Long term protocol: Perform non-invasive neuro-navigated repeated Transcranial Magnetic
      Stimulation (rTMS) at low frequencies (LF) with 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.). Using a double-blinded, sham-controlled design, we will enroll up to
      100 participants aged 18-80 with focal and generalized retractable epilepsy. Baseline data
      will include a detailed seizure diary over 4 weeks, psychometric testing/neuropsychology
      evaluation, and 20-minute EEG recordings. Each patient will then begin treatment with 14
      minute sessions of 1 Hz rTMS or sham rTMS, 120%MT, and 800 stimuli on the position of the
      calculated 3D source using EEG, MRI, and digitized electrode locations. The protocol will be
      divided in 3 groups (Groups 1, 2 and 3) as follows:

        -  Groups 1, 2, and 3: LF-rTMS for 2 weeks (5 days per week for total of 10 days).

        -  Group 1: protocol total duration: 1 year: LF-rTMS 1 session/week for 1 month (4 days),
           and LF-rTMS 1 session/month for 11 months

        -  Group 2: protocol total duration: 1 year: LF-rTMS 1 session/month for 12 months

        -  Group 3 (placebo protocol, total duration: 1 year): LF-rTMS 1 session/week for 1 month
           (4 days); and LF-rTMS 1session/month.

      During each session EEG may be recorded. Also, we will obtain the number, frequency, and
      duration of seizure events from an ongoing seizure diary. Psychometric testing will be
      performed at the beginning of study, 3 months, and at the end of the study. Thus, each
      patient will have rTMS testing, psychometrics, and EEG recordings. With the same rTMS
      modality, we will also perform motor threshold mapping in conjunction with its fully
      integrated and compatible electroencephalography (EEG) module.

      Short-term protocol: Use LF-rTMS protocol as described but for up to 5 days in 10
      participants with medically refractory status epilepticus. During each session EEG will be
      recorded.
    


Study Type

Interventional


Primary Outcome

Average weekly seizure frequency (long-term protocol)

Secondary Outcome

 Scalp EEG: Ratio of right to left Alpha power (long-term protocol)

Condition

Epilepsy

Intervention

Low frequency repeated TMS (LF-rTMS)

Study Arms / Comparison Groups

 Group 1: Weekly TMS
Description:  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

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Device

Estimated Enrollment

110

Start Date

February 19, 2016

Completion Date

December 2023

Primary Completion Date

December 2023

Eligibility Criteria

        Long-term protocol:

        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

        Short-term protocol:

        Inclusion Criteria:

          -  Epilepsia partialis continua or status epilepticus

          -  At least 2 medications failed

          -  At least 24 hours of acute phase

        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)
      

Gender

All

Ages

18 Years - 80 Years

Accepts Healthy Volunteers

No

Contacts

Alberto Pinzon, M.D., Ph.D., , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT03154307

Organization ID

15-135


Responsible Party

Principal Investigator

Study Sponsor

Baptist Health South Florida

Collaborators

 U.S. National Science Foundation

Study Sponsor

Alberto Pinzon, M.D., Ph.D., Principal Investigator, Baptist Health South Florida


Verification Date

July 2022