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Acoustic Stimulation for Seizure Suppression

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ClinicalTrials.gov Identifier: NCT03198494
Recruitment Status : Enrolling by invitation
First Posted : June 26, 2017
Last Update Posted : June 18, 2019
Sponsor:
Information provided by (Responsible Party):
NYU Langone Health

Brief Summary:
The objective of this study is to test the feasibility and physiological effect of low-frequency (1 Hz) acoustic stimulation delivered during nocturnal NREM sleep in epilepsy patients. The long-term goal is to develop this protocol for daily, long-term use in a home setting, for nocturnal seizure and IED suppression

Condition or disease Intervention/treatment Phase
Epilepsy Other: Acoustic 1Hz Stimulation Other: Sham Background Noise Not Applicable

Detailed Description:
  1. To test the feasibility of wearing an earphone system delivering acoustic stimulation during a night of sleep in adult epilepsy patients monitored in an inpatient unit.
  2. To determine the acute physiological effects of low-frequency acoustic stimulation on interictal epileptiform discharge (IED) frequency during NREM sleep in adult patients with epilepsy in an ambulatory setting.
  3. To determine the feasibility of applying low-frequency acoustic stimulation in a long-term home setting in adult epilepsy patients with frequent nocturnal seizures.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Low Frequency Acoustic Stimulation During Sleep for Seizure Suppression
Actual Study Start Date : August 17, 2017
Estimated Primary Completion Date : August 17, 2019
Estimated Study Completion Date : August 17, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Acoustic 1Hz Stimulation
1 Hz acoustic stimulation applied via headphones and downloadable phone application during sleep every night.
Other: Acoustic 1Hz Stimulation
1Hz acoustic pulses delivered during sleep via headphones

Sham Comparator: Sham Background Noise
Background noise applied via headphones and downloadable phone application during sleep every night.
Other: Sham Background Noise
Background Noise used as a control

No Intervention: Baseline Seizure Monitoring
No use of sound system; Patients record seizures in a diary.



Primary Outcome Measures :
  1. Successful System Training [ Time Frame: 72 hours ]
    Assessment of how well participants learn to use stimulation smart-phone application and headphones, defined as the percentage of subjects with correctly maintained earphones during the first four hours of nocturnal sleep in the first days of use.

  2. Interictal Discharge frequency [ Time Frame: 72 hours ]
    IED frequency during nighttime sleep as measured by a 72 hour ambulatory EEG

  3. System Adherence [ Time Frame: 2 months ]
    Percentage of nights during which patients were compliant with the acoustic stimulation device during two months of home use (1 month control acoustic condition, 1 month 1Hz stimulation) determined weekly by patient self-report


Secondary Outcome Measures :
  1. System Use effect on Features of Sleep [ Time Frame: 72 hours ]
    Effect of system use on sleep features, including time spent in each stage of sleep, delta and spindle power and spatial distribution gather from EEG.

  2. Seizure Control [ Time Frame: 3 months ]
    Seizure frequency during control and treatment months gathered from seizure diary and IED frequency gathered from EEG (1 month baseline, 1 month sham stimulation, 1 month 1Hz stimulation).



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18-60 years old
  • Able to provide informed consent
  • MOCA ≥26
  • Fluent in English
  • Frequent nocturnal IEDs (≥ 10% of the sleep record)
  • Monitored on the adult epilepsy monitoring unit (EMU, for Aim 1 only) Additional inclusion criteria for Aim 3
  • Frequent nocturnal seizures (≥1 per week)

Exclusion Criteria:

  • Hearing impairment
  • Diagnosis of a sleep disorder (sleep apnea, periodic limb movements of sleep, or other medical conditions with frequent arousals)
  • Psychoactive medication use (other than AEDs, for example SSRIs, antipsychotics, BDZ, or stimulants)
  • Seizures ≤ 24 hours prior to study.
  • Alcohol or recreational drug use in the 24 hours prior to the study
  • BMI ≥ 30
  • MOCA <26
  • History of recent travel across time zones within the 1 month prior to study activities
  • Shift work for 1 month prior to study activities Additional Exclusion Criteria for Aim 3
  • No medication changes at least 1 month before study, and during 3 months of study activities

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): NCT03198494


Locations
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United States, New York
New York University School of Medicine
New York, New York, United States, 10016
Sponsors and Collaborators
NYU Langone Health
Investigators
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Principal Investigator: Anli Liu NYU Langone Health

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Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT03198494     History of Changes
Other Study ID Numbers: 17-00698
First Posted: June 26, 2017    Key Record Dates
Last Update Posted: June 18, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Seizures
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms