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Auditory Stimulation for Epilepsy
N/A
Recruiting
Led By Dara Manoach, PhD
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Aged 12-65
Inpatients with epilepsy
Must not have
Intellectual disability impairing ability to perform task
Motor problems that preclude finger tapping task
Timeline
Screening 3 weeks
Treatment Varies
Follow Up three nights of sleep within three weeks
Awards & highlights
No Placebo-Only Group
Summary
This trial will study whether playing noise at specific times can improve memory in epilepsy patients with implanted hippocampal electrodes.
Who is the study for?
This trial is for English-speaking epilepsy patients aged 12-65 who are inpatients with implanted hippocampal electrodes and can consent to the study. It's not suitable for those with intellectual disabilities affecting task performance, anticipated surgery that could affect sleep oscillations, or motor issues preventing finger tapping tasks.
What is being tested?
The study tests if brief bursts of noise during sleep can enhance brain rhythms and improve memory in epilepsy patients. Participants will perform a motor procedural memory task with and without auditory stimulation while undergoing EEG monitoring.
What are the potential side effects?
Since this trial involves non-invasive auditory stimulation and standard memory tasks, side effects may be minimal but could include discomfort from the noise or fatigue from performing the memory tasks.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 12 and 65 years old.
Select...
I am hospitalized due to epilepsy.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have an intellectual disability that affects my daily tasks.
Select...
I cannot perform tasks that require tapping my fingers due to motor issues.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ three nights of sleep within three weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~three nights of sleep within three weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Changes in slow oscillation-spindle-hippocampal ripple coupling
Secondary study objectives
Changes in hippocampal ripples
Changes in sleep spindles
Changes in sleep-dependent consolidation of motor procedural memory
+1 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Epilepsy inpatientsExperimental Treatment3 Interventions
Epilepsy inpatients with implanted hippocampal electrodes and continuous scalp EEG monitoring
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Who is running the clinical trial?
Massachusetts General HospitalLead Sponsor
3,015 Previous Clinical Trials
13,309,310 Total Patients Enrolled
8 Trials studying Epilepsy
588 Patients Enrolled for Epilepsy
Dara Manoach, PhDPrincipal InvestigatorProfessor
2 Previous Clinical Trials
100 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You are currently having continuous monitoring of brain activity with implanted electrodes.I have an intellectual disability that affects my daily tasks.I had surgery that may have affected my sleep patterns.I am between 12 and 65 years old.I cannot perform tasks that require tapping my fingers due to motor issues.I am hospitalized due to epilepsy.
Research Study Groups:
This trial has the following groups:- Group 1: Epilepsy inpatients
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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