Transcranial Stimulation During Sleep to Improve Cognition in Epilepsy

NCT02268591 | Withdrawn DMC

• 1 other identifier: S13-00539
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

Aim 1: Determine whether sleep enhances learning across a range of cognitive domains in healthy subjects. Aim 2: Determine whether low-frequency transcranial stimulation (TCS) delivered during slow wave sleep (SWS), compared to sham stimulation, enhances learning outcomes as indexed by a complete neuropsychological battery of tests in epilepsy patients and healthy control subjects. Aim 3: Determine whether low-frequency TCS delivered during SWS, compared to sham stimulation, enhances sleep architecture associated with enhanced memory consolidation (ie. increased coherence of slow wave activity and increased frequency of sleep spindles). Aim 4. Determine whether low-frequency TCS during sleep results in a more distributed memory representation, as suggested by increased hippocampal-perirhinal connectivity on fMRI in human subjects. Aim 5. Determine whether the frequency of interictal activity during sleep in epilepsy subjects is associated with the degree of cognitive benefit conferred by SWS. These studies will provide critical pilot data on whether non-invasive brain stimulation protocols previously tested in healthy subjects can be extended to epilepsy patients for potentially therapeutic cognitive benefits.

Conditions

Epilepsy

Outcome Measures

Primary Outcomes (1)

• Changes in Memory function assessment

  RAVLT, Yellow Cab Navigation Task, Working Memory tasks, Procedural Memory tasks, Insight based tasks.

  Day 1, 2 & 3

Study Arms (2)

Transcranial Stimulator

ACTIVE COMPARATOR

We will apply oscillating current at a slow frequency of 0.5-1.5 Hz during early sleep, which is rich in slow waves \[ie non-REM sleep\]. The peak intensity of stimulation which allows for optimal phase entrainment will be determined in pilot studies. However, peak stimulation intensities will not exceed 2 mA (as discussed above). The current will be applied over the left and right prefrontal cortex (F3, F4), corresponding to the predominant region of slow oscillations, during the onset of deep sleep to the first REM episode (early non-REM-rich sleep).

Device: Transcranial Stimulator

Sham Stimulation

NO INTERVENTION

The EEG and stimulation electrodes will be placed as in the stimulation sessions, but stimulation will not be administered.

Interventions

Transcranial Stimulator DEVICE

A non invasive brain stimulation which delivers low amplitude current through scalp electrodes by a Transcranial Stimulator

Also known as: TCS

Transcranial Stimulator

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 18-70 years
• Must score 22 or more on the MoCA.
• Must be able to provide informed consent.
• Must be fluent in English.
• Diagnosis of focal epilepsy

You may not qualify if:

• Patient has a progressive or unstable neurological or systemic disease
• Patient has a history of severe traumatic brain injury or prior brain surgery with skull defect
• Contraindictations to TCS, including metal in the head or implanted brain medical devices
• Pregnancy
• Any implanted electrical medical device, including pacers and implanted cardiac defibrillators
• History of schizophrenia, schizoaffective disorder, other psychosis, rapid-cycling bipolar illness, alcohol/drug abuse within the past year
• History of dementia
• History of known sleep disorder
• Ictal Focus over the F3 or F4 field
• Clinical or electrographic evidence of frequent nocturnal seizures, as determined with recent (\<2 year) ambulatory EEG.
• Generalized epilepsy

Sponsors & Collaborators

• NYU Langone Health: lead

MeSH Terms

Conditions

Epilepsy

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Anli Liu, MD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 2, 2014
• First Posted: October 20, 2014
• Study Start: May 28, 2013
• Primary Completion: May 27, 2014
• Study Completion: May 27, 2014
• Last Updated: March 15, 2018

Record last verified: 2018-03