Medically Intractable Epilepsy Clinical Trial
Official title:
Pilot Trial: Personalizing Health Outcome in Epilepsy Now - An Introduction to Clinical Services
The assumption of the unpredictability of seizures may have an enormous impact on the perception of self-efficacy and may contribute more to a patient's poor quality-of-life than the actual seizures. Patients with epilepsy are especially susceptible to the influence of the arbitrary nature of this condition on socialization,education,and the formation of self-identity. Consequentially, the psychosocial and psychological aftermath is likely to be observed even in individuals with well-controlled seizures. The relationship between seizure occurrence and the effects of having epileptic seizures on quality of life can be characterized as reciprocal; e.g. emotional stress is not only a result of having seizures; it is also the most frequently reported seizure precipitant. Whereas behavioral interventions have repeatedly been considered as the third pillar of the treatment of epilepsy, the main focus still remains on passive seizure control per pharmacological and surgical interventions, which may further aggravate victimization. Outcome after epilepsy surgery is closely correlated with pre-surgical characteristics. Consequentially, there is an upsurge of interest in the medical community for research on non-pharmacologic interventions to facilitate the transition from chronically sick to well with preventive therapeutic interventions in the context of habitual seizures. The Andrews/Reiter (AR) approach to epilepsy is a systematic counseling intervention that assists the individual to identify seizure warning signs,seizure precipitants and general life stressors in order to develop strategies of active seizure control and improve self-defined life quality. Literature review indicates that AR represents the most comprehensively developed psychological approach. The proposed trial will address the question if AR decreases seizure frequency and psychopathologic comorbidities and increases seizure self-efficacy and overall quality of life in patients with medically intractable epilepsy.
Potential subjects will be systematically approached during a 3 years enrollment period to
recruit a consecutive sample of the patient population receiving care at a tertiary care
epilepsy center (Toronto Western Hospital). After an 8 week period to establish baseline
measurements the proposed trial will allocate study subjects to an A/R intervention group or
a relaxation/meditation control group or a usual care control group (N1=N2=N3=10) per their
preference due to the fact that internalization of the therapeutic principles is an active
process that requires continuous motivation and compliance of the patient with the
intervention. If a subject displays high intrinsic motivation to engage in self-care
enhancing activities but does not indicate a preference, he or she will get randomized to
either the A/R intervention or the relaxation protocol. This trial design allows for
measuring effect sizes in regard the potential effect of choice, and also whether there is
any interaction between preference and treatment.
This trial will determine the following:
I. The fraction of (a) seizure-free subjects and (b) subjects with clinically meaningful,
i.e. ≥ 90% or ≥ 50 reduction of seizure frequency, II. Changes of the subjective perception
of disability as indicated by Subjective Handicap of Epilepsy Scale (SHE), III. Changes of
seizure self-efficacy as indicated by Multidimensional Health Locus of Control (M-HLOC),
Form C and Epilepsy Self-Efficacy Scale (ESES), IV. Changes in common psychopathologic
comorbidities and stress as indicated by (a) Neurological Disorders Depression Inventory in
Epilepsy (NDDI-E), (b) State Trait Anxiety Inventory (STAI), (c) Profile of Mood States
(POMS brief), and (d) Perceived Stress Scale (PSS), V. Changes in quality of life as
indicated by (a) Quality of Life in Epilepsy (QOLIE-89), (b) individually identified
descriptors of various domains of life and (c) individually identified epilepsy-related
distresses. Continuous measures (aims I and III b) will be obtained during months 9 and 10
after initial subject enrollment. All other measures will be obtained at the end of month
10.
Intervention Protocols: During months 3-5 the A/R intervention protocol devotes one
face-to-face counseling session to each of the 11 chapters ("steps") of the workbook "Taking
control of your epilepsy" which will be followed by weekly phone calls during months 6-8.
A/R treatment plans include daily activities: Journaling (10 min), CD-guided relaxation
(10-30 min), Workbook (10 min) to promote functional analysis of seizure context and
development of coping strategies. The trial will be used for knowledge-translation as
trainees delivering the intervention will be supervised by Donna Andrews, PhD, co-developer
of the AR intervention. The relaxation and meditation protocol will consist of weekly 30 min
session during months 3-5 and bi-weekly 60 min sessions during months 6-8.
All subjects are instructed to document seizure occurrences (number and type) and compliance
with AEDs. They will continue to see their treating neurologist and adjustment of their
antiepileptic medication will be made if necessary. Medication changes will be included in
outcome analyses. Regular serum levels will be drawn to monitor drug compliance. Study
subjects will be approached at 12, 24 and 36 months after the end of the pilot trial to
obtain follow-up data. The sample size determination the investigators based on literature
review, assuming the remission rate for the usual care group was 5% and 35% for the A/R
intervention group and inflated by 30% to account for loss to non-compliance. Outcomes will
be compared as found in groups as a whole.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Enrolling by invitation |
NCT05273970 -
Electrochemical and Electrophysiological Study
|
N/A |