Medically Intractable EpilepsyPHOENICSNCT01533649
Personalizing Health Outcome in Epilepsy Now - An Introduction to Clinical Services
A study testing Andrews/Reiter approach to epilepsy and Relaxation/Meditation in people with Medically Intractable Epilepsy, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Medically Intractable Epilepsy
- What is being tested?
- Andrews/Reiter approach to epilepsy and Relaxation/Meditation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2012to Sep 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age 18-40 years old
- Fluency in English, including reading and writing
- Confirmed diagnosis of epilepsy as indicated by review of medical records (video-EEG, routine EEG and imaging)
- Drug-refractoriness as indicated by at least two failures to achieve seizure freedom per adequate drug trials in the patient's history
- Eligibility to be subjected to a surgical intervention aiming at seizure reduction
- A baseline seizure frequency of at least two complex partial seizures per month
Show all 9Show fewer
- Willingness not to begin another non-pharmaceutical treatment while enrolled in the study
- Readiness to attempt not to change pharmaceutical treatment while enrolled in the study
- Motivation to comply with the intervention protocols
Who cannot join
- A history of a relapsing remission course of epilepsy
- Presumed psychogenic events
- Scheduled or likely change of treatment within 8 months after enrollment in the trial
- Negative compliance history
- Noncompliance with baseline measurement
- A seizure frequency of less than two seizures per month during baseline measurement
- Serious other medical problems, such cancer, stroke, significant heart disease, psychiatric disorders
- Brain tumors, vascular malformations, progressive epilepsy syndromes, neurodegenerative disorders or significant developmental delay (IQ<80)
Trial locations and contacts
1 site in 1 country.
Canada1 site
Toronto Western Hospital
Toronto, Ontario, M5T 2S8
Taufik A Valiante, MD PhD FRCS, 416-603 ext. 5460, taufik.valiante@uhn.ca
Taufik A Valiante, MD PhD FRCS
About this study
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.
Read the detailed description
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:
- 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.
- Conditions
- Medically Intractable Epilepsy
- Being tested
- Andrews/Reiter approach to epilepsy, Relaxation/Meditation
- Keywords
- Behavioral intervention, Seizure self-efficacy, Psychosocial outcomes, Quality of Life in Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Andrews/Reiter approach to epilepsyBehavioural
Also called A/R intervention
The Andrews/Reiter approach to epilepsy is a systematic semi-directive, multi-modal counseling intervention that integrates conventional therapies, educational modules, psychological interventions and relaxation techniques in order to assist the individual in improving self-defined life quality. Face-to-face counseling sessions and supervision with telephone calls are based on a standardized workbook ("Taking Control of Your Epilepsy") as an on-going step-by-step guideline.
Relaxation/MeditationBehavioural
Subjects who participate in the relaxation control group will attend weekly relaxation sessions that will employ the following relaxation techniques: meditation, progressive muscle relaxation, autogenic training.
| Study group | Role | What they receive |
|---|---|---|
| A/R intervention | Experimental | The A/R intervention will accommodate 10 study subjects who will participate in an epilepsy-specific counseling intervention. Receives: Behavioral: Andrews/Reiter approach to epilepsy |
| Relaxation | Experimental | The relaxation group will accommodate 10 study subjects who will participate in a condition unspecific supportive relaxation intervention. Receives: Behavioral: Relaxation/Meditation |
| Usual care | No intervention | 10 Potential study subjects who are not interested in participating in either intervention will be asked to provide data as a usual care control group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fraction of seizure free study subjects
The determination of the fraction of seizure-free study subjects will be the primary outcome measure of this pilot trial. Seizure freedom will be defined as absence of seizures (not auras) during months 9 and 10 after initial subject enrollment.
Measured: Change from baseline seizure frequency obtained during months 1 and 2 at months 9 and 10 after initial subject enrollment.
Secondary outcomes (5)
Fraction of subjects achieving a clinically meaningful reduction of seizure frequency
The fraction of subjects achieving a clinically meaningful reduction of seizure frequency will be determined. Reduction of seizure frequency will be categorized as ≥ 90% reduction of seizures or ≥ 50% reduction of seizures
Measured: Change from baseline seizure frequency obtained during months 1 and 2 at months 9 and 10 after initial subject enrollment.
Subjective Handicap of Epilepsy
Changes as indicated by the completion of the subjective Handicap of Epilepsy 32-item (SHE) scale at baseline and at the end of month 10 after subject enrollment.
Measured: Change from baseline questionnaire scores obtained during month 1 at month 10 after initial subject enrollment
Health-related self-efficacy
Changes as indicated by the completion of the 18-item Multidimensional Health Locus of Control (M-HLOC) Questionnaire.Different aspects of efficacy in the self-management of epilepsy will be measured using the 2000 version 33-item Epilepsy Self-Efficacy Scale (ESES). The fraction of days with reported medication side effects will be determined comparing documentations obtained during the initial 8 weeks of baseline measurement with adverse event documentation obtained during months 9 and 10 after initial subject enrollment.
Measured: Change from baseline questionnaire scores and fraction of days with reported side effects obtained during months 1 and 2 at months 9 and 10 after initial subject enrollment.
Psychopathologic disorders and stress
Changes in the 6-item Neurological Disorders Depression Inventory in Epilepsy (NDDI-E), the State Trait Anxiety Inventory (STAI), the 30-item Profile of Mood States (POMS-Brief), and the 14-item Perceived Stress Scale (PSS)
Measured: Change from baseline questionnaire scores obtained during month 1 at month 10 after initial subject enrollment.
Quality of life
Changes in regard to 89-item Quality of Life in Epilepsy (OLIE-89) questionnaire.
Measured: Change from baseline questionnaire scores obtained during month 1 at month 10 after initial subject enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2012 (estimated)
- Study startApr 2012
- Primary completionSep 2013 (estimated)
- Study completionSep 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Medically Intractable EpilepsyStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Taufik A Valiante, MD PhD FRCS, Principal investigator, Toronto Western Hospital; University Health Networks
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01533649
- Sponsor's protocol ID
- PHOENICS-01
- Acronym
- PHOENICS
- Status last verified
- Feb 2012
- First submitted
- 6 Feb 2012
- Last updated
- 15 Feb 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Reiter JM, Andrews DJ. A neurobehavioral approach for treatment of complex partial epilepsy: efficacy. Seizure. 2000 Apr;9(3):198-203. doi: 10.1053/seiz.1999.0374.
PubMed 10775516
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Trial: Personalizing Health Outcome in Epilepsy Now - An Introduction to Clinical Services
- ClinicalTrials.gov ID
- NCT01533649
- Acronym / sponsor ID
- PHOENICS / PHOENICS-01
- Conditions
- Medically Intractable Epilepsy
- Keywords
- Behavioral intervention, Seizure self-efficacy, Psychosocial outcomes, Quality of Life in Epilepsy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- Apr 2012
- Primary completion
- Sep 2013 (estimated)
- Study completion
- Sep 2013 (estimated)
- First posted
- 15 Feb 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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:
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A/R intervention | Experimental | Behavioral: Andrews/Reiter approach to epilepsyThe A/R intervention will accommodate 10 study subjects who will participate in an epilepsy-specific counseling intervention. |
| Relaxation | Experimental | Behavioral: Relaxation/MeditationThe relaxation group will accommodate 10 study subjects who will participate in a condition unspecific supportive relaxation intervention. |
| Usual care | No intervention | –10 Potential study subjects who are not interested in participating in either intervention will be asked to provide data as a usual care control group. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Age 18-40 years old
- Fluency in English, including reading and writing
- Confirmed diagnosis of epilepsy as indicated by review of medical records (video-EEG, routine EEG and imaging)
- Drug-refractoriness as indicated by at least two failures to achieve seizure freedom per adequate drug trials in the patient's history
- Eligibility to be subjected to a surgical intervention aiming at seizure reduction
Key exclusion criteria (8 listed)
- A history of a relapsing remission course of epilepsy
- Presumed psychogenic events
- Scheduled or likely change of treatment within 8 months after enrollment in the trial
- Negative compliance history
- Noncompliance with baseline measurement
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Andrews/Reiter approach to epilepsyAlso: A/R interventionThe Andrews/Reiter approach to epilepsy is a systematic semi-directive, multi-modal counseling intervention that integrates conventional therapies, educational modules, psychological interventions and relaxation techniques in order to assist the individual in improving self-defined life quality. Face-to-face counseling sessions and supervision with telephone calls are based on a standardized workbook ("Taking Control of Your Epilepsy") as an on-going step-by-step guideline. | Behavioural | A/R intervention |
| Relaxation/MeditationSubjects who participate in the relaxation control group will attend weekly relaxation sessions that will employ the following relaxation techniques: meditation, progressive muscle relaxation, autogenic training. | Behavioural | Relaxation |
Primary outcome
Fraction of seizure free study subjects
Time frame: Change from baseline seizure frequency obtained during months 1 and 2 at months 9 and 10 after initial subject enrollment.
The determination of the fraction of seizure-free study subjects will be the primary outcome measure of this pilot trial. Seizure freedom will be defined as absence of seizures (not auras) during months 9 and 10 after initial subject enrollment.
5 secondary outcomes
Fraction of subjects achieving a clinically meaningful reduction of seizure frequency
Time frame: Change from baseline seizure frequency obtained during months 1 and 2 at months 9 and 10 after initial subject enrollment.
Subjective Handicap of Epilepsy
Time frame: Change from baseline questionnaire scores obtained during month 1 at month 10 after initial subject enrollment
Health-related self-efficacy
Time frame: Change from baseline questionnaire scores and fraction of days with reported side effects obtained during months 1 and 2 at months 9 and 10 after initial subject enrollment.
Psychopathologic disorders and stress
Time frame: Change from baseline questionnaire scores obtained during month 1 at month 10 after initial subject enrollment.
Quality of life
Time frame: Change from baseline questionnaire scores obtained during month 1 at month 10 after initial subject enrollment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2012.
- Background: PubMed 10775516Reiter JM, Andrews DJ. A neurobehavioral approach for treatment of complex partial epilepsy: efficacy. Seizure. 2000 Apr;9(3):198-203. doi: 10.1053/seiz.1999.0374.
- Link to Andrews/Reiter epilepsy research.inc who have been applying the studied intervention for more than 30yrs.Link provided by the sponsor.
Related trials for Medically Intractable Epilepsy
Not yet recruiting
High-Intensity Focused Ultrasonic Ablation of the Centromedian Thalamic Nucleus for Treatment of Medically Refractory Generalized Epilepsy in Patients Ages 18 Years to 89 Years
Idiopathic Generalized Epilepsy
RecruitingObservational study
Surgery as a Treatment for Medically Intractable Epilepsy
Epilepsy, Epilepsy, Temporal Lobe
RecruitingEarly Phase 1
Optimization of Deep Brain Stimulation Parameters in Patients With Medically Refractory Epilepsy
Refractory Epilepsy, Deep Brain Stimulation
Active, not recruitingPhase 2
RNS System LGS Feasibility Study
Epilepsy, Lennox Gastaut Syndrome
Recruiting
Spatial Scene Recognition Memory in Epilepsy Surgery
Focal Epilepsy, Temporal Lobe Epilepsy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Taufik A Valiante, MD PhD FRCS principal investigator
Toronto Western Hospital; University Health Networks
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Andrews/Reiter approach to epilepsy and Relaxation/Meditation in people with Medically Intractable Epilepsy, run by University Health Network, Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Taufik A Valiante, MD PhD FRCS (647-261 ext. 7823, taufik.valiante@uhn.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fraction of seizure free study subjects (time frame: Change from baseline seizure frequency obtained during months 1 and 2 at months 9 and 10 after initial subject enrollment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01533649, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2012.