The epilepsy monitoring unit (EMU) is a valuable resource for optimizing management of persons with epilepsy, but may place patients at risk for adverse events due to withdrawal of treatment and induction of symptoms. The purpose of this study was to synthesize data on the safety and quality of care in EMUs to inform the development of quality indicators for EMUs.Methods
A systematic review was conducted according to the Preferred Reporting and Items for Systematic Review and Meta-Analysis (PRISMA) statement. The search strategy, which included broad search terms and synonyms pertaining to the EMU, was run in six medical databases and included conference proceedings. Data abstracted included patient and EMU demographics and quality and safety variables. Study quality was evaluated using a modified 15-item Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) checklist. Descriptive statistics and meta-analyses were used to describe and synthesize the evidence.Results
The search yielded 7,601 references, of which 604 were reviewed in full text. One-hundred thirty-five studies were included. The quality and safety data came from 181,823 patients and reported on 34 different quality and safety variables. Included studies commonly reported the number of patients (108 studies; median number patients, 171.5), age (49 studies; mean age 35.7 years old), and the reason for admission (34 studies). The most common quality and safety data reported were the utility of the EMU admission (38 studies). Thirty-three studies (24.4%) reported on adverse events, and yielded a pooled proportion of adverse events of 7% (95% confidence interval [CI] 5–9%). The mean quality score was 73.3% (standard deviation [SD] 17.2).Significance
This study demonstrates that there is a great deal of variation in the reporting of quality and safety measures and in the quality and safety in EMUs. Study quality also varied considerably from one study to the next. These findings highlight the need to develop evidence-based, consensus-driven quality indicators for EMUs.
A feasibility trial of an Internet-delivered and transdiagnostic cognitive behavioral therapy treatment program for anxiety, depression, and disability among adults with epilepsy
Anxiety and depression are highly prevalent in people with epilepsy (PWE) and contribute to increased disability. Unfortunately, there are numerous barriers (e.g., cost, distance, and stigma) and service gaps (e.g., lack of services and trained clinicians) that prevent many PWE from accessing traditional face-to-face psychological services. The aim of the present study was to examine the feasibility of a new transdiagnostic Internet-delivered cognitive behavioral therapy (iCBT) program, the Chronic Conditions Course, to simultaneously treat symptoms of anxiety, depression, and disability.Methods
A single-group feasibility open trial was employed involving 27 adults with epilepsy. The program comprises five online lessons delivered over 8 weeks and is provided with weekly contact from a mental health professional via e-mail and telephone.Results
High treatment completion rates and levels of satisfaction were reported. Evidence of significant improvements in our primary outcomes (within-group Cohen's d [d]; average [avg.] reductions) of anxiety (d ≥ 1.28; avg. reduction ≥ 54%), depression (d ≥ 1.24; avg. reduction ≥ 54%), epilepsy-specific depression (d ≥ 0.95; avg. reduction ≥ 35%), and disability (d ≥ 0.62; avg. reduction ≥ 33%) were observed at posttreatment, which were sustained at or further improved to 3-month follow-up. On our secondary outcomes there were significant improvements for life satisfaction (d ≥ 0.70; avg. improvement ≥ 26%) but not for perceived cognitive difficulties (d ≥ 0.48; avg. reduction ≥ 15%). Highlighting the potential of the approach, relatively little clinician time was required per participant (mean 80.62 min, standard deviation [SD] 54.78), and the trial involved a broad range of geographically dispersed patients.Significance
The findings of the current study support the feasibility and potential of transdiagnostic Internet-delivered treatments for adults with epilepsy. Further large-scale controlled trials are warranted.
The use of antiepileptic drugs (AEDs) may decrease the levels of folic acid and vitamin B12 in the blood, according to a study published in the international scientific journal, Biomedical Reports.
According to the authors this could be linked to a higher risk of stroke in people with different types of epilepsy. Therefore, giving these people regular folic acid and vitamin B12 supplements may be beneficial*.
For the study, a team of scientists at The First People’s Hospital of Xuzhou, in China, analysed 68 people with epilepsy. Eight of them had autonomic seizures, 10 had absence seizures, 13 had complex partial seizures, 28 had generalized tonic-clonic seizures and nine had simple partial seizures. All participants received appropriate AED treatment for their type of epilepsy.
After one year of treatment, the researchers analysed the differences in the level of folic acid and vitamin B12 in the blood of the participants, as well as any events of stroke.
They found that there was no difference in the levels of folic acid and vitamin B12 in the blood of participants who had different types of epilepsy. This was the case both before and after the start of treatment with AEDs. However, when they looked at the levels of folic acid and vitamin B12 in the blood of the participants in each group before and after AED treatment, they saw that the levels had decreased following treatment.
The researchers also found that there was no difference in the incidence of strokes between the groups, but that strokes were associated with the levels of folic acid and vitamin B12 in the blood. In-depth statistical analysis revealed that levels of folic acid and vitamin B12 may be independent risk factors for the development of stroke in epilepsy.
The authors conclude that, although additional studies are required to confirm these results, folic acid and vitamin B12 supplements might decrease the risk of stroke in people who are taking AEDs.
Author: Dr Özge Özkaya
*Please note that taking supplements without medical advice may be harmful. Please consult with your doctor before taking any supplements.
Click here for more articles about anti-epileptic drugs and pregnancy risks.
Researchers at the University of Colorado have identified a new biomarker that could predict the onset and progression of seizures associated with epilepsy.
Biomarkers are substances found in the blood or urine that can indicate a biological state or a medical condition. They are invaluable in helping clinicians diagnose or predict the progression of a condition and measure how well the body responds to a certain treatment.
The study, published in the scientific journal Redox Biology, suggests that the ratio of two forms of an amino acid (building blocks of proteins) called cysteine could be used as a reliable biomarker to predict the onset or progression of epileptic seizures.
Dr Manisha Patel and Dr Li-Ping showed that the levels of cysteine decreased by 42% and 62% respectively in two different rat models of epilepsy, whilst the levels of cystine, the oxidised form of the amino acid, increased by 46% and 23% respectively. When the scientists treated the animals with an antioxidant, the decrease in the cysteine/cystine ratio was abolished.
The researchers concluded that the ratio of cysteine/cystine could be a reliable measure of epilepsy.
In a press release, Dr Patel said: “Currently the field of epilepsy lacks peripheral blood-based biomarkers that could predict the onset or progression of chronic seizures following an epileptogenic injury. We are confident that this study is a significant step toward changing this, and will one day help those living with temporal lobe epilepsy.”
Author: Dr Özge Özkaya
Click here for more articles about brain science including genetics.
The progestin-containing intrauterine device, also known as the coil, is a safe and well-tolerated form of contraception for women with epilepsy, according to a study published in the scientific journal, Epilepsia.
“Although popular among all women, complex drug interactions limit the efficacy and safety of oral contraceptives for [women with epilepsy],” the authors write.
They add: “Effective contraception enables women with epilepsy to plan their pregnancies and improve outcomes for themselves and their children.”
For the study, a team of researchers led by Dr Alison Pack, from Columbia University Medical Center, analysed 20 women with well-controlled epilepsy, who were on a stable antiepileptic drug (AED) regime. The AED most frequently taken amongst the group was lamotrigine. The average age of the women was 28, and 60% of them had not been pregnant before. All had experienced multiple seizures in the past.
The researchers measured the lowest (or ‘trough’) concentration of AED in the blood of the women before insertion of the coil, and again three weeks, three months and six months after. They did this because, for seizure control and AED safety to be maintained, it is important the level doesn’t change significantly.
The results showed that the lowest concentration of AED in the blood of the women remained stable during the six months following insertion of the coil.
The researchers also asked the women to record their seizures in a daily diary. They then compared the seizures that occurred during the month before insertion of the coil with those occurring in the six month following insertion.
During the month prior to insertion of the coil, 75% of the women did not have any seizures, whilst the remaining 25% had between one and three seizures.
After insertion of the coil, seizure frequency increased in three women, remained unchanged in 13 women and decreased in four women. Interestingly, none of the women said they felt a decrease in seizure control as a result of the coil.
The authors report that all participants were either “somewhat satisfied” or “very satisfied” with the coil, and that all participants continued to use it six months after insertion. They also confirm that no pregnancies occurred during the study.
These results suggest that the coil is an acceptable form of contraception for women with epilepsy.
Author: Dr Özge Özkaya
Click here to read more stories about living with epilepsy.
A gluten-free diet could help control seizures in people with epilepsy who have celiac disease, according to a study published in the scientific journal Advances in Clinical and Experimental Medicine.
The researchers, led by Dr Mohammad Ghadami, at Kermanshah University of Medical Sciences, in Iran, studied 113 people with epilepsy in two Iranian hospitals. They first measured the levels of a protein called ‘anti-immunoglobulin A (IgA) antibody’ in their blood, which is indicative of celiac disease. They then took two to three small intestine biopsies from those tested positive for IgA antibodies, to confirm the presence of celiac disease. A total of seven people (6% of all those with epilepsy) were diagnosed with celiac disease in this way.
These seven people then received a gluten-free diet for five months and their seizure activity was recorded. The results showed that at the end of the five months, seizures were completely under control and antiepileptic drugs were discontinued for six of the seven subjects. For the remaining one paticipant, anticonvulsant drugs were reduced by half and seizures were controlled.
These findings suggest that people with epilepsy who have gastrointestinal symptoms should be screened for celiac disease, since the administration of a combination of a gluten-free diet and anticonvulsant treatment may be effective in treating them.
Celiac disease is a genetic autoimmune condition affecting the small intestine, which gets worse when gluten-containing foods such as wheat and its products are consumed.
Although the mechanisms underlying the association between celiac disease and epilepsy are not fully understood, some researchers have speculated that antibodies related to celiac disease may be toxic for neurons and trigger the development of epilepsy. A number of studies have shown that epilepsy can also develop in other immune-mediated conditions such as systemic lupus and myasthenia gravis.
Author: Dr Özge Özkaya
Click here for more articles about conditions related to epilepsy.
Tuberous sclerosis complex (TSC) is an autosomal-dominant genetic disorder with highly variable expression. The most common neurologic manifestation of TSC is epilepsy, which affects approximately 85% of patients, 63% of whom develop treatment-resistant epilepsy. Herein, we evaluate the efficacy, safety, and tolerability of cannabidiol (CBD), a nonpsychoactive compound derived from the marijuana plant, as an adjunct to current antiepileptic drugs in patients with refractory seizures in the setting of TSC.Methods
Eighteen of the 56 patients who have enrolled in our current expanded-access study of cannabidiol for patients with treatment-resistant epilepsy carry a diagnosis of TSC. After an initial baseline period of 1 month, patients began treatment with CBD. The initial dose of 5 mg/kg/day was increased by 5 mg/kg/day every week up to a maximum dose of 50 mg/kg/day, if tolerated. Weekly seizure frequencies, percent change in seizure frequencies, and responder rates were calculated during the 2nd, 3rd, 6th, 9th, and 12th month of treatment with CBD.Results
The median weekly seizure frequency during the baseline period was 22.0 (interquartile range [IQR] 14.8–57.4), which decreased to 13.3 (IQR 5.1–22.1) after 3 months of treatment with cannabidiol. The median percent change in total weekly seizure frequency was −48.8% (IQR −69.1% to −11.1%) after 3 months of treatment. The 50% responder rates over the course of the study were 50%, 50%, 38.9%, 50%, and 50% after 2, 3, 6, 9, and 12 months of treatment with CBD, respectively. In patients taking clobazam concurrently with CBD (n = 12), the responder rate after 3 months of treatment was 58.3%, compared to 33.3% in patients not taking clobazam (n = 6). Twelve (66.7%) of 18 patients in this study experienced at least one adverse event thought possibly related to CBD; the most common adverse events were drowsiness (n = 8, 44.4%), ataxia (n = 5, 27.8%), and diarrhea (n = 4, 22.2%).Significance
Although double-blind, placebo-controlled trials are still necessary, these findings suggest that cannabidiol may be an effective and well-tolerated treatment option for patients with refractory seizures in TSC.
Please note that Epilepsy Research UK does not endorse/promote individual epilepsy treatments or pharmaceutical companies.
Marinus Pharmaceuticals has announced the results of a phase two clinical trial evaluating its drug candidate, ganaxolone, for the treatment of PCDH19 epilepsy. They show that ganaxolone was generally safe, well-tolerated and reduced seizure frequency in most participants.
In a press release, Dr Michael G. Chez, Paediatric Neurologist at Sutter Medical Center in Sacramento, California, and an investigator in the trial said: “The benefit that ganaxolone provided in reducing seizures is clinically meaningful for these difficult-to-treat patients with a severe, rare epilepsy… In addition to seizure reduction, the patients that I treated with ganaxolone displayed improved behavior and cognitive skills during treatment.”
“A drug that can lessen seizure burden and behavioral comorbidities caused by this disease would be welcomed by patients, their families and the medical community,” he added.
The study enrolled 11 girls with PCDH19 epilepsy, aged 4 to 15 years. The children were first observed for a period of 12-weeks to assess their seizure frequency, and then given ganaxolone for 26 weeks.
The results showed that seizure frequency was reduced in seven participants (64%) following treatment with ganaxolone. In addition, eight subjects (73%) had more seizure-free days during treatment with ganaxolone than during the 12-week period prior to the start of treatment.
The company is now enrolling participants with other forms of paediatric genetic epilepsies, such as CDKL5 and Lennox-Gastaut Syndrome.
PCDH19 epilepsy is a rare form of genetic epilepsy that mostly affects girls. It is characterised by early onset seizures and cognitive and behavioural difficulties.
The condition is caused by a mutation in the PCDH19 gene, located on the X-chromosome. This causes the protein the gene encodes for, which supports communication between the cells of the nervous system, not to function properly or to be absent altogether.
Although there are currently no approved drugs to treat this form of epilepsy, in 2015, the US Food and Drug Administration granted orphan drug designation to ganaxolone, which will help accelerate its development as a potential treatment.
Author: Dr Özge Özkaya
Click here for more articles about other treatments for epilepsy.
Following a sudden death at a residential care unit, the Dutch Health and Care Inspectorate advised intensification of the use of video monitoring (VM) at the unit. We assessed whether VM resulted in increased identification of seizures that required clinical intervention.Methods
The unit provides care for 340 individuals with refractory epilepsy and severe learning disabilities. Acoustic detection systems (ADSs) cover all individuals; 37 people also have a bed motion sensor (BMS) and 46 people with possible nocturnal seizures are now monitored by VM. During a 6-month period, in all cases of a suspected seizure we asked the caregivers to specify which device alerted them and to indicate whether this led to an intervention. Staff costs of VM were estimated using payroll information.Results
We identified 1,208 seizures in 37 individuals: 4 had no nocturnal seizures and 393 (33%) seizures were seen only on video. In 169 (14%) of 1,208 seizures an intervention was made and this included 39 (10%) of 393 seizures seen only on video. When compared to seizures observed with an ADS or BMS, seizures seen only on video were more often tonic seizures (71% vs. 22%, p < 0.001) and occurred mostly in the beginning or at the end of the night (40% vs. 26%, p < 0.001). The extra staff costs of monitoring was 7,035 euro per seizure seen only on video and leading to an intervention.Significance
VM facilitates nocturnal surveillance, but the costs are high. This underscores the need for development of reliable seizure detection devices.