For the first time, the effect of multiple lifestyle interventions on seizure control and epilepsy-associated comorbidities in adults with difficult-to-treat epilepsy is being prospectively studied in a longitudinal randomized trial.
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The study — recently launched at Cleveland Clinic as a single-center investigation with support of a $5.5 million donation from the Charles L. Shor Foundation — promises to illuminate links between epilepsy and stress by assessing the discrete impacts of cognitive behavioral therapy, yoga and music therapy on seizure control.
Adjunctive interventions needed for difficult-to-treat epilepsy
“Almost one-third of people with epilepsy have recurrent seizures despite the use of multiple anti-seizure medications,” says Imad Najm, MD, Director of Cleveland Clinic’s Charles Shor Epilepsy Center and the study’s principal investigator. “Moreover, people with epilepsy often have cognitive deficits as well as psychosocial and psychiatric issues that impact daily functioning and quality of life, including increased levels of stress. Our study objective is to evaluate nonpharmacologic lifestyle interventions as an adjunct to standard anti-seizure medication therapy to determine whether stress relief can reduce seizures and ultimately reduce or prevent memory decline.”
Although stress has been identified as a major risk factor for seizure recurrence and decreased memory function in people with epilepsy, studies of stress-reducing interventions in this population have been subject to limitations. These include evaluation of just a single intervention modality, small sample sizes, limited or no randomization, short duration or poor characterization of participants’ epilepsy. “Our study will be the first comprehensive and large-scale investigation of this question,” Dr. Najm says.
Details of the study design
The researchers plan to enroll up to 1,000 participants in the study and follow them for 12 months. All will be adults with a confirmed diagnosis of epilepsy and at least one seizure within the prior month. Patients are randomized into one of five groups:
- Three intervention groups, who will undergo either cognitive-behavioral therapy (CBT), yoga therapy or music therapy (in addition to standard epilepsy care)
- Two control groups, who will receive standard epilepsy care plus either weekly or monthly phone check-ins with a study coordinator
All patients complete screening evaluations, neurocognitive assessment and quality-of-life questionnaires at enrollment. For those in the intervention groups, this is followed by three months of live virtual instructor-guided intervention and then nine months of self-guided intervention; control patients continue with their scheduled phone calls throughout the 12-month study period.
Patients in all groups will undergo evaluations at three, six and 12 months involving the following:
- Completion of 10 validated health questionnaires assessing seizure severity, medication adherence, quality of life, perceived stress, anxiety, depression, self-efficacy, physical activity, overall health and sleep quality
- Cognitive assessment using a brief neuropsychological battery measuring attention, processing speed, language, executive functioning, memory and visuospatial skills
- Collection of daily seizure tracking logs
A closer look at the intervention strategies
The CBT intervention aims to provide psycho-educational and behavioral health strategies to promote seizure prevention and stress management. The three months of instructor-guided intervention involve a weekly 90-minute virtual group counseling session led by a psychologist and a co-therapist. The nine months of self-guided intervention involve periodic 15- to 30-minute semi-structured phone calls with the psychologist or co-therapist.
The yoga intervention is designed to teach gentle yoga focused on meditation, breathing exercises and mindfulness techniques to foster well-being and stress reduction. Patients start by engaging in 70-minute virtual live yoga classes led by a yoga therapist twice weekly for the first month and once weekly for months 2 and 3. Patients are urged to practice on their own at home for up to 30 minutes daily on non-class days. During the nine months of self-guided intervention, patients engage in online prerecorded yoga classes.
The music therapy intervention seeks to teach development of stress-reducing skills through incorporation of music into participants’ daily lives. The instructor-guided intervention involves 70-minute virtual live music therapy sessions led by a music therapist; they are held twice weekly in month 1 and once weekly in months 2 and 3. Over the nine months of self-instruction, patients are given prompts and options to independently engage in weekly music experiences to sustain and build on those introduced during guided instruction.
Endpoints and hypotheses
The study’s primary outcome measure is seizure frequency, which will be tracked daily by all patients throughout the 12-month study duration. Secondary outcome measures are stress level, mood, anxiety, cognitive function and quality-of-life scores.
“We hypothesize that patients in the intervention groups will experience greater seizure reductions than those in the control groups,” Dr. Najm notes, “along with reductions in stress, depression and anxiety as well as improvements in cognitive function and quality of life relative to the control groups.”
He adds that if the study’s findings are positive, “that will support incorporating behavioral and wellness-based lifestyle interventions into the everyday management of patients with epilepsy.”