EpilepsyNCT02950506
Transcranial Direct Current Stimulation and Cognitive Remediation Therapy for Interictal Dysfunction in Epilepsy
A study testing transcranial direct current stimulation and Cognitive Remediation Therapy in people with Epilepsy, run by University of Minnesota at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Epilepsy
- What is being tested?
- transcranial direct current stimulation and Cognitive Remediation Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2020to 1 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota Comprehensive Epilepsy Center(MINCEP)
Saint Louis Park, Minnesota, 55416
About this study
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.
Read the 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.
- Conditions
- Epilepsy
- Being tested
- transcranial direct current stimulation, Cognitive Remediation Therapy
- Keywords
- Interictal, Cognitive, Dysfunction, tDCS, transcranial direct current stimulation
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcranial direct current stimulationDevice
Also called tDCS, Starstim, Starstim Enobio, Starstim 20
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.
Cognitive Remediation TherapyOther
Also called CRT, Cogmed
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Cognitive Remediation Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
Measured: 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)
Measured: 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.
Measured: 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.
Measured: Change from baseline to 5 days, 1 month, and 3 months after last intervention visit.
Secondary outcomes (3)
Oral Symbol Digit Test
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.
Measured: Change from baseline to 5 days, 1 month, and 3 months after last intervention visit.
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.
Measured: Change from baseline to 5 days, 1 month, and 3 months after last intervention visit.
Quality of Life
To asses quality of life the Quality of Life in Epilepsy Inventory 31 will be administered.
Measured: Change from baseline to 5 days, 1 month, and 3 months after last intervention visit.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2016 (estimated)
- Study start1 Jan 2020
- Primary completion1 Mar 2020
- Study completion1 Mar 2020
Why it stopped: Lack of resources
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (38)Papers the sponsor has linked to this study.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thomas Henry, MD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02950506
- Sponsor's protocol ID
- CTSI24219
- Status last verified
- Jan 2022
- First submitted
- 10 Aug 2016
- Last updated
- 18 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: There is currently no plan to make individual participant data available.
Publications
Andrews SC, Hoy KE, Enticott PG, Daskalakis ZJ, Fitzgerald PB. Improving working memory: the effect of combining cognitive activity and anodal transcranial direct current stimulation to the left dorsolateral prefrontal cortex. Brain Stimul. 2011 Apr;4(2):84-9. doi: 10.1016/j.brs.2010.06.004. Epub 2010 Jul 11.
PubMed 21511208Benedict, Ralph H B, David Schretlen, Lowell Groninger, and Jason Brandt. 1998. "Hopkins Verbal Learning Test - Revised: Normative Data and Analysis of Inter-Form and Test-Retest Reliability." The Clinical Neuropsychologist 12 (1): 43-55.
Benson N, Hulac DM, Kranzler JH. Independent examination of the Wechsler Adult Intelligence Scale-Fourth Edition (WAIS-IV): what does the WAIS-IV measure? Psychol Assess. 2010 Mar;22(1):121-30. doi: 10.1037/a0017767.
PubMed 20230158Boggio PS, Ferrucci R, Rigonatti SP, Covre P, Nitsche M, Pascual-Leone A, Fregni F. Effects of transcranial direct current stimulation on working memory in patients with Parkinson's disease. J Neurol Sci. 2006 Nov 1;249(1):31-8. doi: 10.1016/j.jns.2006.05.062. Epub 2006 Jul 14.
PubMed 16843494Brandt, J. & Benedict, R. (2001). Hopkins Verbal Learning Test-Revised: Professional Manual. PAR: Florida
Brunelin J, Mondino M, Haesebaert F, Saoud M, Suaud-Chagny MF, Poulet E. Efficacy and safety of bifocal tDCS as an interventional treatment for refractory schizophrenia. Brain Stimul. 2012 Jul;5(3):431-432. doi: 10.1016/j.brs.2011.03.010. Epub 2011 Apr 24. No abstract available.
PubMed 22037120Brunoni AR, Amadera J, Berbel B, Volz MS, Rizzerio BG, Fregni F. A systematic review on reporting and assessment of adverse effects associated with transcranial direct current stimulation. Int J Neuropsychopharmacol. 2011 Sep;14(8):1133-45. doi: 10.1017/S1461145710001690. Epub 2011 Feb 15.
PubMed 21320389Cramer JA, Perrine K, Devinsky O, Bryant-Comstock L, Meador K, Hermann B. Development and cross-cultural translations of a 31-item quality of life in epilepsy inventory. Epilepsia. 1998 Jan;39(1):81-8. doi: 10.1111/j.1528-1157.1998.tb01278.x.
PubMed 9578017Del Felice A, Magalini A, Masiero S. Slow-oscillatory Transcranial Direct Current Stimulation Modulates Memory in Temporal Lobe Epilepsy by Altering Sleep Spindle Generators: A Possible Rehabilitation Tool. Brain Stimul. 2015 May-Jun;8(3):567-73. doi: 10.1016/j.brs.2015.01.410. Epub 2015 Jan 30.
PubMed 25862600Denboer, John W, Christopher Nicholls, Corrine Corte, and Kali Chestnut. 2014. "National Institutes of Health Toolbox Cognition Battery." Archives of Clinical Neuropsychology: The Official Journal of the National Academy of Neuropsychologists, August. doi:10.1093/arclin/acu033.
Dikmen SS, Bauer PJ, Weintraub S, Mungas D, Slotkin J, Beaumont JL, Gershon R, Temkin NR, Heaton RK. Measuring episodic memory across the lifespan: NIH Toolbox Picture Sequence Memory Test. J Int Neuropsychol Soc. 2014 Jul;20(6):611-9. doi: 10.1017/S1355617714000460. Epub 2014 Jun 24.
PubMed 24960230Engelberts NH, Klein M, Ader HJ, Heimans JJ, Trenite DG, van der Ploeg HM. The effectiveness of cognitive rehabilitation for attention deficits in focal seizures: a randomized controlled study. Epilepsia. 2002 Jun;43(6):587-95. doi: 10.1046/j.1528-1157.2002.29401.x.
PubMed 12060017Falleti MG, Maruff P, Collie A, Darby DG. Practice effects associated with the repeated assessment of cognitive function using the CogState battery at 10-minute, one week and one month test-retest intervals. J Clin Exp Neuropsychol. 2006 Oct;28(7):1095-112. doi: 10.1080/13803390500205718.
PubMed 16840238Fregni F, Thome-Souza S, Nitsche MA, Freedman SD, Valente KD, Pascual-Leone A. A controlled clinical trial of cathodal DC polarization in patients with refractory epilepsy. Epilepsia. 2006 Feb;47(2):335-42. doi: 10.1111/j.1528-1167.2006.00426.x.
PubMed 16499758Fregni F, Boggio PS, Nitsche M, Bermpohl F, Antal A, Feredoes E, Marcolin MA, Rigonatti SP, Silva MT, Paulus W, Pascual-Leone A. Anodal transcranial direct current stimulation of prefrontal cortex enhances working memory. Exp Brain Res. 2005 Sep;166(1):23-30. doi: 10.1007/s00221-005-2334-6. Epub 2005 Jul 6.
PubMed 15999258
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcranial Direct Current Stimulation and Cognitive Remediation Therapy for Interictal Dysfunction in Epilepsy
- ClinicalTrials.gov ID
- NCT02950506
- Acronym / sponsor ID
- CTSI24219
- Conditions
- Epilepsy
- Keywords
- Interictal, Cognitive, Dysfunction, tDCS, transcranial direct current stimulation
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lack of resources
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 1 Mar 2020 (actual)
- Study completion
- 1 Mar 2020 (actual)
- First posted
- 1 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active tDCS | Active comparator | Device: transcranial direct current stimulation, Other: Cognitive Remediation TherapyThere 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. |
| Sham tDCS | Sham comparator | Other: Cognitive Remediation TherapyThere 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. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| transcranial direct current stimulationAlso: tDCS, Starstim, Starstim Enobio, Starstim 20The 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. | Device | Active tDCS |
| Cognitive Remediation TherapyAlso: CRT, CogmedThe 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 | Active tDCS, Sham tDCS |
Primary outcome
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.
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)
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)
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.
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.
3 secondary outcomes
Oral Symbol Digit Test
Time frame: Change from baseline to 5 days, 1 month, and 3 months after last intervention visit.
Cogstate Brief Battery
Time frame: 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.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2022.
- Background: PubMed 21511208Andrews SC, Hoy KE, Enticott PG, Daskalakis ZJ, Fitzgerald PB. Improving working memory: the effect of combining cognitive activity and anodal transcranial direct current stimulation to the left dorsolateral prefrontal cortex. Brain Stimul. 2011 Apr;4(2):84-9. doi: 10.1016/j.brs.2010.06.004. Epub 2010 Jul 11.
- BackgroundBenedict, Ralph H B, David Schretlen, Lowell Groninger, and Jason Brandt. 1998. "Hopkins Verbal Learning Test - Revised: Normative Data and Analysis of Inter-Form and Test-Retest Reliability." The Clinical Neuropsychologist 12 (1): 43-55.
- Background: PubMed 20230158Benson N, Hulac DM, Kranzler JH. Independent examination of the Wechsler Adult Intelligence Scale-Fourth Edition (WAIS-IV): what does the WAIS-IV measure? Psychol Assess. 2010 Mar;22(1):121-30. doi: 10.1037/a0017767.
- Background: PubMed 16843494Boggio PS, Ferrucci R, Rigonatti SP, Covre P, Nitsche M, Pascual-Leone A, Fregni F. Effects of transcranial direct current stimulation on working memory in patients with Parkinson's disease. J Neurol Sci. 2006 Nov 1;249(1):31-8. doi: 10.1016/j.jns.2006.05.062. Epub 2006 Jul 14.
- BackgroundBrandt, J. & Benedict, R. (2001). Hopkins Verbal Learning Test-Revised: Professional Manual. PAR: Florida
- Background: PubMed 22037120Brunelin J, Mondino M, Haesebaert F, Saoud M, Suaud-Chagny MF, Poulet E. Efficacy and safety of bifocal tDCS as an interventional treatment for refractory schizophrenia. Brain Stimul. 2012 Jul;5(3):431-432. doi: 10.1016/j.brs.2011.03.010. Epub 2011 Apr 24. No abstract available.
- Background: PubMed 21320389Brunoni AR, Amadera J, Berbel B, Volz MS, Rizzerio BG, Fregni F. A systematic review on reporting and assessment of adverse effects associated with transcranial direct current stimulation. Int J Neuropsychopharmacol. 2011 Sep;14(8):1133-45. doi: 10.1017/S1461145710001690. Epub 2011 Feb 15.
- Background: PubMed 9578017Cramer JA, Perrine K, Devinsky O, Bryant-Comstock L, Meador K, Hermann B. Development and cross-cultural translations of a 31-item quality of life in epilepsy inventory. Epilepsia. 1998 Jan;39(1):81-8. doi: 10.1111/j.1528-1157.1998.tb01278.x.
- Background: PubMed 25862600Del Felice A, Magalini A, Masiero S. Slow-oscillatory Transcranial Direct Current Stimulation Modulates Memory in Temporal Lobe Epilepsy by Altering Sleep Spindle Generators: A Possible Rehabilitation Tool. Brain Stimul. 2015 May-Jun;8(3):567-73. doi: 10.1016/j.brs.2015.01.410. Epub 2015 Jan 30.
- BackgroundDenboer, John W, Christopher Nicholls, Corrine Corte, and Kali Chestnut. 2014. "National Institutes of Health Toolbox Cognition Battery." Archives of Clinical Neuropsychology: The Official Journal of the National Academy of Neuropsychologists, August. doi:10.1093/arclin/acu033.
- Background: PubMed 24960230Dikmen SS, Bauer PJ, Weintraub S, Mungas D, Slotkin J, Beaumont JL, Gershon R, Temkin NR, Heaton RK. Measuring episodic memory across the lifespan: NIH Toolbox Picture Sequence Memory Test. J Int Neuropsychol Soc. 2014 Jul;20(6):611-9. doi: 10.1017/S1355617714000460. Epub 2014 Jun 24.
- Background: PubMed 12060017Engelberts NH, Klein M, Ader HJ, Heimans JJ, Trenite DG, van der Ploeg HM. The effectiveness of cognitive rehabilitation for attention deficits in focal seizures: a randomized controlled study. Epilepsia. 2002 Jun;43(6):587-95. doi: 10.1046/j.1528-1157.2002.29401.x.
- Individual participant dataSharing planned: No. There is currently no plan to make individual participant data available.
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Focal Seizure, Epilepsy
Active, not recruitingObservational study
Transforming Research and Clinical Knowledge in Traumatic Brain Injury Epileptogenesis Project (TRACK-TBI EPI)
Traumatic Brain Injury, Post-traumatic Epilepsy
RecruitingPhase 3
Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures FOCUS-1
Focal Seizure, Epilepsy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Henry, MD principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing transcranial direct current stimulation and Cognitive Remediation Therapy in people with Epilepsy, run by University of Minnesota at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 18 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cogstate Brief Battery (time frame: Change from baseline to 5 days, 1 month, and 3 months after last intervention visit.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02950506, which also lists 38 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2022.