Effect of Auditory Stimulation on Spike Waves in Sleep

Epilepsy Clinical Trial

— ECLASS  

Official title:

Effect of Closed-loop Auditory Stimulation on Spike Waves During Slow Wave Sleep, an Open Label Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02562885
• Other study ID #: SW2015
• Status: Completed
• Phase: N/A
• First received: September 21, 2015
• Last updated: January 12, 2017
• Start date: October 2015
• Est. completion date: December 2016

Study information

• Verified date: December 2016
• Source: University Children's Hospital, Zurich
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Background: Close relationship exists between sleep slow wave (SSW) and the generation of spike wave in NREM-sleep. SSW are cortically generated oscillations alternating between excitatory depolarization ("Up-phase" of the SSW) and inhibitory hyperpolarization ("Down-phase" of the SSW). It has been shown experimentally that with increasing synchrony of slow neuronal oscillations SSW turn into spike waves. Acoustic pulses applied in correspondence to the SSW "Up-phase" enhance the amplitude of the subsequent SSW. Conversely, tones delivered at the SSW "Downphase" have a disruptive effect on the following SSW.

Participants: Patients with epilepsy and spike waves in NREM-sleep.

Objective: Modification of spike wave frequency, amplitude and spreading during NREM sleep by acoustic pulses applied at the "Up-" or "Down-phase" of SSW.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 12 Years

Eligibility

Inclusion Criteria:

• Participants with Rolandic epilepsy/BECTS

• Participants with ESES/CSWS

• Participants with generalized spike waves in sleep

• EEG within 6 months before study night consistent with the diagnosis

Exclusion Criteria:

• Clinically significant concomitant acute or chronic disease

• Seizure frequency >1/week, history of convulsive status epilepticus or seizures provoked by sleep deprivation

• Severe sleep problems

• Treatment with corticosteroids, immunosuppressive or vagus nerve stimulation

Related Conditions & MeSH terms

• Epilepsy
• Sleep

Intervention

Device:
• Acoustic pulses
Acoustic pulses applied during NREM sleep slow waves "Up-phase" or "Down-phase". The acoustic stimulus will be delivered by speakers with a volume of about 50 dB.

Locations

Country	Name	City	State
Switzerland	Div. of Clinical Neurophysiology/Epilepsy, University Children's Hospital Zurich	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
University Children's Hospital, Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Spike wave index	Change of spike wave index during acoustic pulses applied at the "Up-" or "Down-phase" of sleep slow waves. Spike wave index given in percent and calculated by number of seconds within 10 second windows with spike waves over the whole 15 minutes of the block design part.	Change baseline (without) and with acoustic pulses in the same NREM period: 45 minutes
Secondary	Spike wave amplitude	Change of spike wave amplitude (in microvolts) during acoustic pulses applied at the "Up-" or "Down-phase" of sleep slow waves. Amplitudes of maximum spike will be analyzed in 10 seconds periods of the first and the last 100 seconds of every part of the block design. EEG source derivation will be used for the analysis. The mean of the 3 highest amplitudes of each 10 seconds period will be determined and the mean of the 10 periods will presented in mean and SD.	Change baseline (without) and with acoustic pulses in the same NREM period: 45 minutes
Secondary	Spike wave spreading	Change of spike wave spreading during acoustic pulses applied at the "Up-" or "Down-phase" of sleep slow waves. Spreading will be analyzed in 10 seconds periods of the first and the last 100 seconds of every part of the block design. EEG source derivation will be used for the analysis. Maximum spike wave spreading (number of electrodes involved) visible in 3 spike waves of each 10 second period will be determined and the mean of the 10 periods will presented in mean and SD.	Change baseline (without) and with acoustic pulses in the same NREM period: 45 minutes
Secondary	Spike wave index in the NREM (2) period following the NREM (1) period with acoustic pulses	Change of spike wave index in the NREM period following the NREM period with acoustic pulses applied at the "Up-" or "Down-phase" of sleep slow waves. Over the first 15 minutes of the following NREM period: Spike wave index given in percent and calculated by number of seconds within 10 second windows with spike waves .	Change baseline (NREM 1) and NREM 2: expected average of 1 hour
Secondary	Spike wave amplitude in the NREM (2) period following the NREM (1) period with acoustic pulses	Change of spike wave amplitude (in microvolts) in the NREM period following the NREM period with acoustic pulses applied at the "Up-" or "Down-phase" of sleep slow waves. Amplitudes of maximum spike will be analyzed in 10 seconds periods of the first and the last 100 seconds of the following NREM period. EEG source derivation will be used for the analysis. The mean of the 3 highest amplitudes of each 10 seconds period will be determined and the mean of the 10 periods will presented in mean and SD.	Change baseline (NREM 1) and NREM 2: expected average of 1 hour
Secondary	Spike wave spreading in the NREM (2) period following the NREM (1) period with acoustic pulses	Change of spike wave spreading in the NREM period following the NREM period with acoustic pulses applied at the "Up-" or "Down-phase" of sleep slow waves. Spreading will be analyzed in 10 seconds periods of the first and the last 100 seconds of the following NREM period. EEG source derivation will be used for the analysis. Maximum spike wave spreading (number of electrodes involved) visible in 3 spike waves of each 10 second period will be determined and the mean of the 10 periods will presented in mean and SD.	Change baseline (NREM 1) and NREM 2: expected average of 1 hour