Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06537986
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-25
Brief Title:
A Neuro-cognitive and Psychosocial Intervention Module in People With Epilepsy
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Testing the Efficacy of a Neuro-cognitive and Psychosocial Intervention Module in People With Epilepsy
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Patients with epilepsy especially drug-resistant epilepsy have a lot of cognitive psycho-social issues There is little evidence pertaining to the efficacy of the various cognitive-behavioral interventions and cognitive retraining modules used in epilepsy patients in the Indian context The real value of these interventions needs further consolidation in terms of its assessment and efficacy The available literature is scanned and having limitations in terms of assessment tool used sample size and also lacks a broader spectrum of psychosocial interventions used In view of the above limitations we plan to specially develop test a Neuro-cognitive and psychosocial intervention module based on the deficits found in these domains that will help DRE patients to improve their quality of life This module will be covering not only the broader spectrum of assessment tools but also varieties of interventions This module will help in planning the future needs of epileptic patients in terms of not only medication but also guide us in choosing the kind of interventions to be used with a particular patient or group of patients
Detailed Description:
We plan to specially develop test a Neuro-cognitive and psychosocial intervention module based on the deficits found in these domains that will help DRE patients to improve their quality of life This module will be covering not only the broader spectrum of assessment tools but also varieties of interventions
AIM To develop and test the efficacy of Neuro-cognitive and psychosocial intervention module in drug-resistant epilepsy
Clinical Sample The sample will consist of patients with Drug-resistant epilepsy DRE Patients with Drug-resistant epilepsy DRE will be included per inclusion and exclusion criteria The subjects will be taken from the patients attending Refractory epilepsy clinic REC Department of Neurology PGIMER Chandigarh
Informed written consent will be obtained from all the study participants per the rules and regulations of the Institutional Ethics Committee of PGIMER
Study design It will be a pre and post-design Subjects fulfilling the inclusion and exclusion criteria will be randomly assigned to intervention and control groups-a Hospital-based Randomized Control Trial Study
Sample Size n60 Follow-up Schedule - Both Pre and post-neuropsychological and psychosocial assessments will be done for all patients
1 Intervention group - will have an intervention module between pre and post-assessment
2 Control group - only follow up between Pre and post-assessment All the randomized patients will be followed up for outcome assessment at 3 to 6 months of the recruitment Depending on the module
Statistical Justification
1 Descriptive statistics will be used in terms of frequency percentages range means and standard deviations
2 Group differences between intervention and control groups will be carried out using a t-test
3 Correlations will be carried out among all the clinical and neuropsychological variables
4 Linear stepwise regression analysis will be carried out for clinical neuropsychological and psychosocial variables separately
5 Other appropriate statistics would be used as per the requirements of the study
AIM To develop and test the efficacy of Neuro-cognitive and psychosocial intervention module in drug-resistant epilepsy
Clinical Sample The sample will consist of patients with Drug-resistant epilepsy DRE Patients with Drug-resistant epilepsy DRE will be included per inclusion and exclusion criteria The subjects will be taken from the patients attending Refractory epilepsy clinic REC Department of Neurology PGIMER Chandigarh
Informed written consent will be obtained from all the study participants per the rules and regulations of the Institutional Ethics Committee of PGIMER
Study design It will be a pre and post-design Subjects fulfilling the inclusion and exclusion criteria will be randomly assigned to intervention and control groups-a Hospital-based Randomized Control Trial Study
Sample Size n60 Follow-up Schedule - Both Pre and post-neuropsychological and psychosocial assessments will be done for all patients
1 Intervention group - will have an intervention module between pre and post-assessment
2 Control group - only follow up between Pre and post-assessment All the randomized patients will be followed up for outcome assessment at 3 to 6 months of the recruitment Depending on the module
Statistical Justification
1 Descriptive statistics will be used in terms of frequency percentages range means and standard deviations
2 Group differences between intervention and control groups will be carried out using a t-test
3 Correlations will be carried out among all the clinical and neuropsychological variables
4 Linear stepwise regression analysis will be carried out for clinical neuropsychological and psychosocial variables separately
5 Other appropriate statistics would be used as per the requirements of the study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None