Epilepsy and comorbid ADHD/ADD
Conditions
Interventions
Trade Name: Ritalin, Methylphenidate
Pharmaceutical Form: Buccal tablet
Sponsors
SSE, Nevroklinikken, Oslo Universitetssykehus
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 9-15 years, known epilepsy, ADHD/ADD according to the current diagnostic criteria, boys and girls Are the trial subjects under 18? yes Number of subjects for this age range: 46 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range 0 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 0
Exclusion criteria
Exclusion criteria: Known depressive reaction/PTSD, more than two anti-epileptic drugs, diagnosis of moderate and severe mental retardation (F.71-F.79 or IQ below 55), medication under review, unstable seizure pattern, unstable life situation, contraindications for methylphenidate.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective of the trial is to evaluate if standardized and computerized workingmemory-training is as effective as traditional treatment (i.e stimulant medication/Methyphenidate) against ADHD symptoms in children and adolecents with attention deficits and epilepsy;Secondary Objective: To assess if WMT improve executive function compared to baseline and to medicated group 12 weeks after inclusion. To assess if WMT influence on seizure-frequency and EEG-patterns compared to baseline ;Primary end point(s): Improvement in workingmemory-tests 12 weeks from baseline in subjects receiving WM-training. The assessed improvement should be at least equal to the improvements in the medicated group. ;Timepoint(s) of evaluation of this end point: Timepoint for all endpoints would be 10-12 weeks after inclusion. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Improvements in parents and teachers questionnaire: BRIEF (Behavior Rating Inventory of executive function) and ADHD-rating-scale - compared to baseline. Does WM-training induce changes in quantified EEG (spike-activity and/or changes in theta/beta ratio) compared to baseline?;Timepoint(s) of evaluation of this end point: Timepoint of this evaluation will be the same as above; between 10-12 weeks after inclusion. | — |
Countries
Norway
Contacts
Public ContactCharlotte Lunde, LiS, OUS
SSE, Nevroklinikken, Oslo Universitetssykehus
Outcome results
None listed