EpilepsySPIRALENCT04749901
Symptoms of Post-traumatic Stress in Adult Drug-resistant Epilepsies
A study testing Psycho-emotional and semiological measures in people with Epilepsy, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial summary
Epilepsy is a neurological disease that can cause many comorbid psychiatric disorders, among them: generalized anxiety disorder and depression. Many studies suggest a temporal relationship between exposure to a traumatic event and the development of epilepsy. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Epilepsy
- What is being tested?
- Psycho-emotional and semiological measures
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 129 participants
- Where
- 1 siteFrance
- Study dates
- 11 Feb 2021to 13 Jun 2023
- 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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Man or woman between 18 and 50 years old;
- Native French speaker;
- Level of education higher than the 3rd school level;
- Certain diagnosis of the pathology of the experimental group with which he will be associated, more precisely:
- Group of patients with epilepsy [Group E]: definite diagnosis of drug-resistant epilepsy (epileptic seizures persist despite the administration of daily treatment) established by a specialist physician.
- Group of patients with a heart rhythm disorder [Group C]: definite diagnosis of one of the following disorders: Atrial Fibrillation (AF); Syncope and Bouveret's disease established by a specialist.
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- Group of patients with T1 diabetes mellitus [Group D]: definite diagnosis of type 1 diabetes established by a specialist doctor.
- Group of patients with PTSD [Group T]: definite diagnosis of PTSD established by a specialist doctor.
- Person having given his non-objection
Who cannot join
- Pregnancy;
- Breastfeeding women;
- Severe cognitive impairment
- Addiction to alcohol or drugs (including drugs other than those related to epilepsy or the chronic disease from which the patient has);
- Other neurological and / or psychiatric disorders than CNEP or epilepsy except anxiety and depressive disorders;
- Adults under guardianship or under judicial protection
- People deprived of their liberty
- Inability to read French.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Symptoms of Post-traumatic Stress in Adult Drug-resistant Epilepsies: Incidence and Influence on Cognitive Control Capacities and on Seizure Control
Epilepsy is a neurological disease that can cause many comorbid psychiatric disorders, among them: generalized anxiety disorder and depression. Many studies suggest a temporal relationship between exposure to a traumatic event and the development of epilepsy. The objective of this research is to study the symptoms of post-traumatic stress disorder (PTS) in patients with epilepsy, and their relation to anxiety and depression in these patients. The investigators also wish to study how such symptoms may be associated with the subjective semiological manifestations of epileptic seizures. In addition, it has been shown that patients with epilepsy are able, from the identification of different warning signs, to anticipate their vulnerability to having an epileptic seizure allowing them to set up different types. strategies to control them. The investigators also wish to study the cognitive processes involved in this control and the influence of PTS symptoms, in particular hypervigilance on this behavior.
The investigators propose a protocol using different types of measures: emotional, cognitive and physiological in order to answer our questions. In addition to patients with epilepsy, two groups of patients will be included: a group of patients with another chronic non-neurological disease to compare the prevalence of PTS symptoms and a group of patients with post-traumatic stress disorder ( PTSD) to compare with patients with epilepsy, cognitive and physiological measures.
Finally, the results of this study should allow to develop tools for assessing PTS symptoms in epilepsy and to develop specific management approaches
- Conditions
- Epilepsy
- Being tested
- Psycho-emotional and semiological measures
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psycho-emotional and semiological measuresOther
Also called Cognitive measures, Physiological measurements, Qualitative measures
Surveys, interviews and measures
| Study group | Role | What they receive |
|---|---|---|
| Patients with epilepsy | Other | Not described Receives: Other: Psycho-emotional and semiological measures |
| Patients with PTSD | Other | Not described Receives: Other: Psycho-emotional and semiological measures |
| Patients with type 1 diabetes | Other | Not described Receives: Other: Psycho-emotional and semiological measures |
| Patients with a heart rhythm disorder | Other | Not described Receives: Other: Psycho-emotional and semiological measures |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety level
Beck Anxiety inventory (0-63), higher values mean worse outcome
Measured: Baseline
Depression
Beck Anxiety inventory (0-21), higher values mean worse outcome
Measured: Baseline
Number of patients with PTSD
Post-traumatic stress disorder
Measured: Baseline
Emotion regulation
The difficulties in emotion regulation scale,(0-180), higher values mean better outcome
Measured: Baseline
Quality of life of the patient
Medical Outcome Study and 36-item Short Form Health Survey (0-60),higher values mean worse outcome
Measured: Baseline
Seizures control
Seizure control scale (0-85), higher values mean better outcome
Measured: Baseline
Seizures control (heart rythm)
HRSC
Measured: Baseline
PTSD
PTSD-E (0-100), higher values mean worse outcome
Measured: Baseline
Emotionnal control of diabete
DID-C (Diabete insulino-dependant-Control) (elaborated for the study) (0-150), higher values mean worse outcome
Measured: Baseline
Emotionnal control of diabete and PTSD
DID-PTSD (Diabete insulino-dependant-Posttraumatic Stress Disorder) (elaborated for the study) (0-185), higher values mean worse outcome
Measured: Baseline
Skin conductance
BIOPAC SCL (EDA 100C)
Measured: Baseline
Eyes movements
EyeLink 1000 (SR Research)
Measured: Baseline
Heart rythm variability
BIOPAC ECG (EL250)
Measured: Baseline
Attentional and executive control
Attentional and executive control task in the context of hypervigilance (elaborated for the study) (0-180), higher values mean worse outcome
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2021
- Study start11 Feb 2021
- Primary completion13 Jun 2023
- Study completion13 Jun 2023
Why it stopped: Impossible to pursue the study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 129 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Olivier ARNAUD, Study director, Assistance Publique Hôpitaux de Marseille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04749901
- Sponsor's protocol ID
- 2020-42
- Other IDs
- ID-RCB
- Acronym
- SPIRALE
- Status last verified
- Jul 2023
- First submitted
- 14 Jan 2021
- Last updated
- 25 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Symptoms of Post-traumatic Stress in Adult Drug-resistant Epilepsies: Incidence and Influence on Cognitive Control Capacities and on Seizure Control
- ClinicalTrials.gov ID
- NCT04749901
- Acronym / sponsor ID
- SPIRALE / 2020-42
- Conditions
- Epilepsy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Impossible to pursue the study
- Enrolment
- 129 participants (actual)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- 11 Feb 2021 (actual)
- Primary completion
- 13 Jun 2023 (actual)
- Study completion
- 13 Jun 2023 (actual)
- First posted
- 11 Feb 2021 (actual)
- 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.
Epilepsy is a neurological disease that can cause many comorbid psychiatric disorders, among them: generalized anxiety disorder and depression. Many studies suggest a temporal relationship between exposure to a traumatic event and the development of epilepsy. The objective of this research is to study the symptoms of post-traumatic stress disorder (PTS) in patients with epilepsy, and their relation to anxiety and depression in these patients. The investigators also wish to study how such symptoms may be associated with the subjective semiological manifestations of epileptic seizures. In addition, it has been shown that patients with epilepsy are able, from the identification of different warning signs, to anticipate their vulnerability to having an epileptic seizure allowing them to set up different types. strategies to control them. The investigators also wish to study the cognitive processes involved in this control and the influence of PTS symptoms, in particular hypervigilance on this behavior.
The investigators propose a protocol using different types of measures: emotional, cognitive and physiological in order to answer our questions. In addition to patients with epilepsy, two groups of patients will be included: a group of patients with another chronic non-neurological disease to compare the prevalence of PTS symptoms and a group of patients with post-traumatic stress disorder ( PTSD) to compare with patients with epilepsy, cognitive and physiological measures.
Finally, the results of this study should allow to develop tools for assessing PTS symptoms in epilepsy and to develop specific management approaches
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Patients with epilepsy | Other | Other: Psycho-emotional and semiological measures |
| Patients with PTSD | Other | Other: Psycho-emotional and semiological measures |
| Patients with type 1 diabetes | Other | Other: Psycho-emotional and semiological measures |
| Patients with a heart rhythm disorder | Other | Other: Psycho-emotional and semiological measures |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Man or woman between 18 and 50 years old;
- Native French speaker;
- Level of education higher than the 3rd school level;
- Certain diagnosis of the pathology of the experimental group with which he will be associated, more precisely:
- Group of patients with epilepsy [Group E]: definite diagnosis of drug-resistant epilepsy (epileptic seizures persist despite the administration of daily treatment) established by a specialist physician.
Key exclusion criteria (8 listed)
- Pregnancy;
- Breastfeeding women;
- Severe cognitive impairment
- Addiction to alcohol or drugs (including drugs other than those related to epilepsy or the chronic disease from which the patient has);
- Other neurological and / or psychiatric disorders than CNEP or epilepsy except anxiety and depressive disorders;
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 |
|---|---|---|
| Psycho-emotional and semiological measuresAlso: Cognitive measures, Physiological measurements, Qualitative measuresSurveys, interviews and measures | Other | Patients with PTSD, Patients with a heart rhythm disorder, Patients with epilepsy, Patients with type 1 diabetes |
Primary outcome
Anxiety level
Time frame: Baseline
Beck Anxiety inventory (0-63), higher values mean worse outcome
Depression
Time frame: Baseline
Beck Anxiety inventory (0-21), higher values mean worse outcome
Number of patients with PTSD
Time frame: Baseline
Post-traumatic stress disorder
Emotion regulation
Time frame: Baseline
The difficulties in emotion regulation scale,(0-180), higher values mean better outcome
Quality of life of the patient
Time frame: Baseline
Medical Outcome Study and 36-item Short Form Health Survey (0-60),higher values mean worse outcome
Seizures control
Time frame: Baseline
Seizure control scale (0-85), higher values mean better outcome
Seizures control (heart rythm)
Time frame: Baseline
HRSC
PTSD
Time frame: Baseline
PTSD-E (0-100), higher values mean worse outcome
Emotionnal control of diabete
Time frame: Baseline
DID-C (Diabete insulino-dependant-Control) (elaborated for the study) (0-150), higher values mean worse outcome
Emotionnal control of diabete and PTSD
Time frame: Baseline
DID-PTSD (Diabete insulino-dependant-Posttraumatic Stress Disorder) (elaborated for the study) (0-185), higher values mean worse outcome
Skin conductance
Time frame: Baseline
BIOPAC SCL (EDA 100C)
Eyes movements
Time frame: Baseline
EyeLink 1000 (SR Research)
Heart rythm variability
Time frame: Baseline
BIOPAC ECG (EL250)
Attentional and executive control
Time frame: Baseline
Attentional and executive control task in the context of hypervigilance (elaborated for the study) (0-180), higher values mean worse outcome
Results and safety
The study was stopped early (reason given: Impossible to pursue the study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2023.
- Individual participant dataSharing planned: No
Related trials for Epilepsy
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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.
Jean-Olivier ARNAUD study director
Assistance Publique Hôpitaux de Marseille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Psycho-emotional and semiological measures in people with Epilepsy, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
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: stopped early, as of the sponsor's last update on 25 Jul 2023. 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 France. 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?
The study was stopped early (reason given: Impossible to pursue the study). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anxiety level (time frame: Baseline). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Jul 2023.