Transcranial Direct Current Stimulation and Cognitive Remediation Therapy for Interictal Dysfunction in Epilepsy

NCT02950506 | Withdrawn FDA Device

• 1 other identifier: CTSI24219
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to investigate whether tDCS enhances the effect of cognitive remediation therapy on cognition and functional outcome in patients with epilepsy. There has been evidence that working memory performance is enhanced in healthy subjects. Acute tDCS studies have found improvements in working memory performance in subjects with other neurological diseases. To date, there have been no published studies examining whether can enhance learning during multi-session cognitive remediation over 2 weeks in subjects with epilepsy. This study could have potential application as a non-invasive clinical intervention for interictal dysfunction in epilepsy.

Conditions

Epilepsy

Keywords

Interictal; Cognitive; Dysfunction; tDCS; transcranial direct current stimulation

Outcome Measures

Primary Outcomes (5)

• Cogstate Brief Battery

  The Cogstate Battery is a computerized cognitive assessment program which measures a wide range of cognitive functions (e.g. psychomotor speed, reaction time, working memory, divided attention, learning), which can be repeated with little to none observed practice effects (Falleti 2006). All tasks within the battery were adaptations of standard neuro-psychological and experimental psychological tests. Time to administer requires approximately 15-20 minutes consists of 8 tasks in the form of card games that are presented in succession.

  Change from baseline to 5 days, 1 month, and 3 months after last intervention visit.

• Rey Auditory Verbal Learning Test (AVLT)

  The Rey Auditory Verbal Learning Test (AVLT) is a measure of immediate auditory and verbal memory as well as delayed recall. Participants are given a list of 15 unrelated words repeated over five different trials and are asked to repeat. Another list of 15 unrelated words are given and the client must again repeat the original list of 15 words and then again after 30 minutes. Approximately 45-50 minutes is required for the procedure. (Loring et al. 2008, Strauss 2006)

  Change from baseline to 5 days, 1 month, and 3 months after last intervention visit.

• Picture Sequence Memory Test

  The Picture Sequence Memory Test (PSMT) is a measure for use in the assessment of episodic memory. Participants are asked to recall, in increasing length, a series of illustrated objects and activities that are presented in a particular order on the computer screen. The participants are asked to recall the sequence of pictures that is demonstrated over two learning trials. The number of pictures may vary depending on the age. The test takes approximately 7 minutes to administer. (Dikmen et al. 2014)

  Change from baseline to 5 days, 1 month, and 3 months after last intervention visit.

• Flanker Inhibitory Control and Attention Task

  This task measures both a participant's attention and inhibitory control. The test requires the participant to focus on a given arrow while inhibiting attention to other arrows surrounding it. (Heaton et al. 2014) Sometimes the middle stimulus is pointing in the same direction as the "flankers" (congruent) and sometimes in the opposite direction (incongruent). Scoring is based on a combination of accuracy and reaction time. The test takes approximately 3 minutes to administer.

  Change from baseline to 5 days, 1 month, and 3 months after last intervention visit.

• Dimensional Change Card Sort Test

  DCCS is an assessment to measure of cognitive flexibility. Two target pictures are presented that vary along two dimensions (e.g., shape and color). Participants are asked to match a series of bivalent test pictures (e.g., yellow balls and blue trucks) to the target pictures, first according to one dimension (e.g., color) and then, after a number of trials, according to the other dimension(e.g., shape). "Switch" trials are also employed, in which the participant must change the dimension being matched. For example, after 4 straight trials matching on shape,the participant may be asked to match on color on the next trial and then go back to shape, thus requiring the cognitive flexibility to quickly choose the correct stimulus. Scoring is based on a combination of accuracy and reaction time. This test takes approximately 4 minutes to administer.

  Change from baseline to 5 days, 1 month, and 3 months after last intervention visit.

Secondary Outcomes (3)

• Oral Symbol Digit Test

  Change from baseline to 5 days, 1 month, and 3 months after last intervention visit.

• Cogstate Brief Battery

  Change from baseline to 5 days, 1 month, and 3 months after last intervention visit.

• Quality of Life

  Change from baseline to 5 days, 1 month, and 3 months after last intervention visit.

Study Arms (2)

Active tDCS

ACTIVE COMPARATOR

There will be a total of 14 visits in the study: will complete a screening visit, an initial visit, 10 session visits with active tDCS(transcranial direct current stimulation) andcognitive remediation therapy, and follow--up visits immediately (within 5 days), 1 and 3 months after the last intervention. Subjects will be informed of their group assignment at the end of the study.

Device: transcranial direct current stimulation; Other: Cognitive Remediation Therapy

Sham tDCS

SHAM COMPARATOR

There will be a total of 14 visits in the study: will complete a screening visit, an initial visit, 10 session visits with sham tDCS and cognitive remediation therapy, and follow--up visits immediately (within 5 days), 1 and 3 months after the last intervention. Subjects will be informed of their group assignment at the end of the study.

Other: Cognitive Remediation Therapy

Interventions

transcranial direct current stimulation DEVICE

The anode will be placed over left DLPFC at F3, according to the 10-20 international system for EEG electrode placement. The cathode will be placed over the contralateral supraorbital area. They will be placed via two saline soaked electrode sponges (3 cm x 4.5 cm).After electrodes have been placed, the participants will be instructed to log into CRT software using a unique patient identifier. The CRT software that will be used will be Cogmed working memory training program (Pearson Education, Inc.)Active tDCS will be applied at a ramp-like fashion from 0 to 2mA over 10 seconds, and will be ramped down for the last 10 seconds of stimulation. Active tDCS will last 20 minutes each session. The sham procedure involves only 30 seconds of stimulation at 2mA.

Also known as: tDCS, Starstim, Starstim Enobio, Starstim 20, Starstim Enobio 20, Neuroelectrics Starstim

Active tDCS

Cognitive Remediation Therapy OTHER

The CRT software that will be used will be Cogmed working memory training program (Pearson Education, Inc.). Cogmed is a targeted computerized training program that has been shown to improve working memory and attention. (Spencer-Smith 2015).

Also known as: CRT, Cogmed

Active tDCS; Sham tDCS

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age 18-64
• Epilepsy diagnosis confirmed by the UMN Comprehensive Epilepsy Center
• Complete seizure logs of the type in standard clinic use at the UMN Comprehensive Epilepsy Center for at least 12 weeks prior to study entry
• Stable CNS medications for the 2 weeks prior to the initiation visit and expected to continue with current medication doses for the two weeks of the intervention
• No diagnosis of mental retardation (IQ not less than 70) or pervasive developmental disorder
• At least one subtest of learning and memory less than --1.5 SD
• Sufficient spoken English so as to be able to comprehend testing procedures
• Competent and willing to provide consent

You may not qualify if:

• Occurrence of generalized convulsive status epilepticus or of complex partial status epilepticus within 1 year prior to study entry
• Occurrence of more than 1 generalized tonic-clonic (GTC) seizure per month, or more than 4 complex partial (CP) seizures per week, as reported in the subject's seizure logs for 12 weeks prior to study entry
• Occurrence of GTC seizure within 48 hours before testing
• Any anti-epileptic medication changes or hospitalizations in the previous 4 weeks
• Additional neurologic disorder other epilepsy and cognitive dysfunctions
• History of metallic cranial plates, screws, or implanted devices
• History of craniotomy

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota Comprehensive Epilepsy Center(MINCEP)

Saint Louis Park, Minnesota, 55416, United States

Location

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MeSH Terms

Conditions

Epilepsy

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

• Thomas Henry, MD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: August 10, 2016
• First Posted: November 1, 2016
• Study Start: January 1, 2020
• Primary Completion: March 1, 2020
• Study Completion: March 1, 2020
• Last Updated: January 18, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)