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

January 3, 2022 updated by: University of Minnesota
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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

Epilepsy is a chronic neurological disorder affecting 50 million people worldwide. Patients suffer not only from recurring seizures, but also from cognitive deficits despite adequate treatment control. Cognitive remediation therapy (CRT) is a therapeutic intervention that has recently shown promise in improving cognitive impairment in many neuropsychological disorders. Transcranial direct current stimulation (tDCS) is a non-invasive method that modulates cortical excitability. It works by applying weak electrical currents to the scalp that induce acute modifications of neuronal membrane potentials, producing long-lasting changes in the bioelectric activity of underlying brain tissue. It is postulated that tDCS enhances benefit gained through cognitive remediation therapy. These interventions have yet to be combined with each other for the treatment of interictal dysfunction in patients with epilepsy. The goal of the study is to investigate whether the introduction of tDCS in addition to CRT is effective in the treatment of cognitive impairment in patients suffering from epilepsy.

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Saint Louis Park, Minnesota, United States, 55416
        • University of Minnesota Comprehensive Epilepsy Center(MINCEP)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 64 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Active tDCS
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
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.
Other Names:
  • tDCS
  • Neuroelectrics Starstim
  • Starstim
  • Starstim Enobio
  • Starstim 20
  • Starstim Enobio 20
Other: Cognitive Remediation Therapy
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).
Other Names:
  • Cogmed
  • CRT
Sham Comparator: Sham tDCS
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
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).
Other Names:
  • Cogmed
  • CRT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cogstate Brief Battery
Time Frame: Change from baseline to 5 days, 1 month, and 3 months after last intervention visit.

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

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

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

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
Time Frame: Change from baseline to 5 days, 1 month, and 3 months after last intervention visit.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cogstate Brief Battery
Time Frame: Change from baseline to 5 days, 1 month, and 3 months after last intervention visit.

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.
Oral Symbol Digit Test
Time Frame: Change from baseline to 5 days, 1 month, and 3 months after last intervention visit.
This instrument is a measure of processing speed. (Denboer et al. 2014). The participant is presented with a set of nine symbols on the computer screen, each associated with a number 1-9, and is then presented with a series of symbols without numbers and is asked to orally say each number that should go with that symbol, without skipping any. The score is equal to the number of symbols correctly identified orally within two minutes. This takes approximately 3 minutes.
Change from baseline to 5 days, 1 month, and 3 months after last intervention visit.
Quality of Life
Time Frame: Change from baseline to 5 days, 1 month, and 3 months after last intervention visit.
To asses quality of life the Quality of Life in Epilepsy Inventory 31 will be administered.
Change from baseline to 5 days, 1 month, and 3 months after last intervention visit.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Minnesota

Investigators

  • Principal Investigator: Thomas Henry, MD, University of Minnesota

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2020

Primary Completion (Actual)

March 1, 2020

Study Completion (Actual)

March 1, 2020

Study Registration Dates

First Submitted

August 10, 2016

First Submitted That Met QC Criteria

October 28, 2016

First Posted (Estimate)

November 1, 2016

Study Record Updates

Last Update Posted (Actual)

January 18, 2022

Last Update Submitted That Met QC Criteria

January 3, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CTSI24219

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

There is currently no plan to make individual participant data available.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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