Computerized Cognitive Training in Epilepsy

Epilepsy Clinical Trial

Official title:

Computerized Cognitive Training in Epilepsy

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02726191
• Other study ID #: 15-00398
• Status: Withdrawn
• Phase: N/A
• First received: March 22, 2016
• Last updated: July 13, 2017
• Start date: January 2017
• Est. completion date: April 2018

Study information

• Verified date: July 2017
• Source: New York University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this randomized uncontrolled single-site trial is to evaluate the efficacy of two novel computerized cognitive enhancing software packages for improving cognitive and behavioral outcomes in patients with epilepsy.

Description:

The proposed investigation will be the first to pit two software packages against each other to evaluate the relative efficacy and feasibility of their use among patients with epilepsy. Pharmacotherapy fails to control seizures in approximately 30% of patients. Use of non-pharmacologic interventions, such as cognitive rehabilitation, has shown some benefit for improving cognitive functions and reducing mood symptoms. Each of the computer exercises employ a set of stimuli that are generalizable and mimic real-world experiences.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 2018
• Est. primary completion date: July 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Documented diagnosis of epilepsy based on medical records. The records will be reviewed by the PI and the approved study personnel to confirm that a diagnosis of epilepsy has been made.

• Must own a computer or have access to the internet.

Exclusion Criteria:

• Full Scale IQ < 80, as assessed by the WASI-II.

• History of chronic progressive neurologic or neurodegenerative illnesses (e.g., Parkinson's disease, multiple sclerosis, dementia, primary or metastatic malignancy). Patients with headache or migraine are not excluded.

• History of Axis I psychiatric illness with psychotic features. (e.g., schizophrenia). Patients with depression or anxiety (treated or untreated) without psychotic features are not excluded.

• Visual or auditory impairment, which precludes participation in part, or all of the testing.

• English as a first language will not be required, but participants must have either received some of their schooling in English or used English in their work for >10 years.

Related Conditions & MeSH terms

• Epilepsy

Intervention

Behavioral:
• Spatial Match Exercise

• Temporal Sequence Reconstruction Exercise

• Token Task Exercise

• Story Recall Exercise

• Sample-Match (Within Modality) Exercise

• Pair-Match (Across-Modality) Exercise

• Triad-FiguresExercise

• Monster Garden Exercise

• Memory Match Exercise

• Memory Matrix Exercise

• Familiar Faces Exercises

• Lost in Migration Exercise

• Playing Koi Exercise

Locations

Country	Name	City	State
United States	New York University School of Medicine	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
New York University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total Index Score from the Repeatable Battery for the Assessment of Neurocognitive Status (RBANS)		8 Weeks
Secondary	The Everyday Cognition Scale (ECog)		8 Weeks
Secondary	Perceived cognitive abilities on an index of subjective cognitive abilities (Cognitive Self-Report Questionnaire; CSRQ-25)		8 Weeks
Secondary	Measure of mood (Geriatric Depression Scale)		8 Weeks