Efficacy of TDCS for Treating Working Memory Dysfunction and Depression in Temporal Lobe Epilepsy

NCT02268578 | Withdrawn Phase 1 DMC

• 1 other identifier: S12-03395
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Memory difficulty ranks among the most common complaints for patients with temporal lobe epilepsy. While these cognitive problems may affect quality of life more than seizure frequency, no effective therapy exists. Transcranial Direct Current Stimulation (tDCS) is a method of safe, noninvasive, and painless brain stimulation delivering low intensity direct current through scalp electrodes to modulate brain activity. Several recently published studies demonstrate the enhancement of working memory and mood with stimulation of the frontal region of the brain. Furthermore, tDCS has never been reported to have induced a seizure. The aim of our study is to determine whether real tDCS can improve memory function and mood. The investigators are enrolling patients with well-controlled temporal lobe epilepsy who have not undergone brain surgery.

Conditions

Epilepsy

Keywords

Transcranial Direct Current Stimulation; TDCS; Memory Dysfunction; Depression

Outcome Measures

Primary Outcomes (1)

• Change in EEG Power

  Visits 1, 5, 6 & 7 over 5 weeks

Secondary Outcomes (1)

• Cognitive Tests

  Visits 1, 5, 6 & 7 over 5 weeks

Study Arms (2)

Transcranial Direct Current Stimulation

ACTIVE COMPARATOR

Subjects will receive a total of 5 sessions on consecutive days. During each session, 2 mA of tDCS will be applied for 20 minutes over the left DLPFC (active or sham). The electrodes will have the size of 35cm2 each. Direct current will be transferred by a saline-soaked pair of surface sponge electrodes and delivered b y a specially developed, battery driven, constant current stimulator with a maximum output of 2mA.

Device: Transcranial Direct Current Stimulation

Sham TDCS

SHAM COMPARATOR

For sham-controlled tDCS subjects, the same montage will be used; however current will be applied for only 30 seconds - this is a reliable method of sham stimulation as sensations arising from tDCS treatment occur only at the beginning of application as also demonstrated by a randomized study (Gandiga et al. 2006).

Procedure: Sham Transcranial Direct Current Stimulation

Interventions

Transcranial Direct Current Stimulation DEVICE

2mA tDCS

Transcranial Direct Current Stimulation

Sham Transcranial Direct Current Stimulation PROCEDURE

Transcranial Direct Current Stimulation is administered but at 0mA

Sham TDCS

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age between 18-70 years
• diagnosis of temporal lobe epilepsy, with seizure focus defined by seizure semiology, EEG, MRI Brain, PET and/or ictal and interictal SPECT.
• Must have a stable seizure frequency in the two (2) months prior to enrollment, as verified by the patient's seizure log and/or clinic notes and without recent antiepileptic medication changes.
• Must score above 22/30 on the Montreal Cognitive Assessment (MoCA).
• Must be able to provide informed consent.

You may not qualify if:

• Patient has a progressive or unstable neurological or systemic disease
• Patient has an ictal focus over the F3 or F4 (DLPFC) field
• Patient has a history of severe depression, as determined by a screen inventory test such as the Beck Depression Inventory or a psychiatrist
• Patient has a history of severe traumatic brain injury or prior brain surgery with skull defect
• Contraindictations to tDCS, 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

Sponsors & Collaborators

• NYU Langone Health: lead
• Epilepsy Foundation: collaborator
• American Epilepsy Society: collaborator
• American Academy of Neurology: collaborator

Study Sites (1)

Neurology

New York, New York, 11106, United States

Location

MeSH Terms

Conditions

Epilepsy; Depression

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Anli Liu, MD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 2, 2014
• First Posted: October 20, 2014
• Study Start: November 1, 2012
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2015
• Last Updated: April 15, 2016

Record last verified: 2016-04

Locations

US (1)