Seizure DisorderNIBMSZSNCT03441867
Neuroimaging Biomarker for Seizures
A study testing Cognitive Behavioral Therapy for Seizures and Standard Medical Care in people with Seizure Disorder and Seizure Disorder, Post Traumatic, run by Providence VA Medical Center at 3 sites in United States.
Trial summary
This multi-site study will examine patients with epilepsy (ES) following head injury [i.e., posttraumatic epilepsy (PTE)] and posttraumatic psychogenic Non-epileptic seizures (PNES) and will compare them to patients with traumatic brain injury (TBI) who do not have seizures using functional neuroimaging. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Seizure Disorder, Seizure Disorder, Post Traumatic, Traumatic Brain Injury
- What is being tested?
- Cognitive Behavioral Therapy for Seizures and Standard Medical Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 224 participants
- Where
- 3 sitesUnited States
- Study dates
- 15 Sep 2017to 14 Sep 2022
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Inclusion criteria for PNES, ES and TBI (w/o PNES or ES) participants
- Individuals with history of documented TBI (any severity).
- Males and Females ages 18-60 years .
- Women of child bearing potential, if currently using appropriate contraception.
- Diagnosed by video/EEG with lone PNES or by EEG with lone ES.
- Patients must have at least 1 PNES or 1 ES during the year prior to enrollment.
Who cannot join
- Exclusion Criteria of PNES, ES and TBI (w/o PNES or ES) participants
- Current or past year self-injurious behavior.
- Current suicidal intent (BDI suicide question 9 score of >1).
- Current or past year psychosis.
- Pending litigation or current application for long term disability.
- Active substance or alcohol use disorder (dependence), per discretion of the investigators.
Show all 14Show fewer
- Serious illness requiring systemic treatment or hospitalization; the participant either completes therapy or is clinically stable on therapy, for at least 30 days prior to study entry.
- Inability to fill out the self-report surveys.
- Women who are or/are attempting to become pregnant during the study.
- Ineligible or unwilling to complete MRI imaging.
- Inability to document TBI.
- Inability or unwillingness to participate in CBT and assigned homework.
- Currently enrolled in cognitive therapy aimed at PNES (Current CBT or other psychotherapy may be administered).
- Concurrent mixed ES/PNES or equivocal video/EEG findings in discerning between ES and PNES will not be enrolled.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of Alabama at Birmingham
Birmingham, Alabama, 35294
Rhode Island Hospital
Providence, Rhode Island, 02903
Providence VA Medical Center
Providence, Rhode Island, 02908
About this study
This multi-site study will examine patients with epilepsy (ES) following head injury [i.e., posttraumatic epilepsy (PTE)] and posttraumatic psychogenic Non-epileptic seizures (PNES) and will compare them to patients with traumatic brain injury (TBI) who do not have seizures using functional neuroimaging.
Read the detailed description
Numerous Veterans and civilians have seizures, which can be epileptic or nonepileptic in nature. Epileptic seizures are caused by abnormal brain cell firing. Nonepileptic seizures appear similar to epileptic seizures, but are associated with traumatic experiences and underlying psychological stressors. Both types of seizure are common and disabling, and many patients with seizures do not have adequate control resulting in loss of quality of life.
In this proposed 3-site study ( Providence, RI and Birmingham, AL), which are epilepsy centers with expertise both in epilepsy and psychogenic nonepileptic seizures (PNES), we will enroll 88 patients with video-EEG confirmed PNES and 88 with confirmed post-traumatic epilepsy (PTE) and will obtain functional neuroimaging before and after they receive a behavioral treatment - Cognitive Behavioral Therapy for Seizures. The functional neuroimaging studies in these patients will be compared to patients with traumatic brain injury without seizures to test the hypothesis that the faulty processing of emotions and stress in patients with PNES/PTE and abnormal brain connectivity have unique signals in patients with seizures compared to Veterans without seizures and that the neuroimaging signatures can be modified using behavioral intervention.
Impact: This grant application for the first study investigating mechanisms of PNES and PTE will provide increased understanding of neural circuitry in PTE and PNES, which can inform PTE and PNES treatments and could change clinical neurologic and psychiatric practice for PTE and PNES.
Participants will be recruited at the Providence VA Medical Center, Rhode Island Hospital, and University of Alabama, Birmingham (UAB).
- Conditions
- Seizure Disorder, Seizure Disorder, Post Traumatic, Traumatic Brain Injury, Non-Epileptic Seizure, Conversion Disorder, Magnetic Resonance Imaging
- Being tested
- Cognitive Behavioral Therapy for Seizures, Standard Medical Care
- Keywords
- Cognitive Behavioral Therapy, Veterans, Quality of Life, Stress Disorders, Post-Traumatic, Convulsion, Non-Epileptic, civilians, healthy volunteers
- Medical subject headings
- Epilepsy, Epilepsy, Post-Traumatic, Brain Injuries, Traumatic, Seizures, Conversion Disorder, Craniocerebral Trauma, Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioral Therapy for SeizuresBehavioural
Also called Cognitive Behavioral Therapy (CBT-Sz), (CBT-Sz) - PNES, (CBT-Sz) - PTE
CBT-informed psychotherapy for patients with PNES and PTE
Standard Medical CareOther
Also called Treatment as Usual
Observational - standard medical care
| Study group | Role | What they receive |
|---|---|---|
| (CBT-Sz) - PNES | Experimental | Participants with history of a head injury and confirmed Psychogenic Non-Epileptic Seizures will complete 2 brain fMRI scans along with 12 weeks of one hour CBT-Sz sessions by a trained therapist. Receives: Behavioral: Cognitive Behavioral Therapy for Seizures |
| (CBT-Sz) - PTE | Experimental | Participants with history of a head injury and confirmed Post-Traumatic Epilepsy (PTE) will complete 2 brain fMRI scans along with 12 weeks of one hour CBT-Sz sessions by a trained therapist. Receives: Behavioral: Cognitive Behavioral Therapy for Seizures |
| TBI Control | Active comparator | Participants with TBI will complete 2 brain fMRI scans. Receives: Other: Standard Medical Care |
| Healthy Volunteer | Active comparator | Healthy control volunteers will complete 2 brain fMRI scans. Receives: Other: Standard Medical Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Epileptic Seizures
epileptic seizure frequency (ES), collected prospectively, using a daily seizure calendar
Measured: Baseline, Weeks 1,2,3,4,5,6,7,8,9,10,11,12, 8 months post baseline, 12 months post baseline
Number of Nonepileptic Seizures (NES)
psychogenic nonepileptic seizure (NES) frequency, collected prospectively, using a daily seizure calendar
Measured: Baseline, Weeks 1,2,3,4,5,6,7,8,9,10,11,12, 8 months post baseline, 12 months post baseline
Structural and Functional Neuroimaging
Brain MRI scans
Measured: Baseline and week 13
Secondary outcomes (3)
Beck Depression Inventory-II (BDI-II)
The BDI-II assesses depression severity from "0" (no Depression-related symptom) to "3" (severe) on each question. The highest possible score is "51", relating to the worst outcome.
Measured: Baseline, Weeks 1,2,3,4,5,6,7,8,9,10,11,12, 8 months post baseline, 12 months post baseline
Beck Anxiety Inventory (BAI)
The BDI-II assesses anxiety severity from "0" (no Anxiety-related symptom) to "3" (severe) on each question.
Measured: Baseline, Weeks 6 and 10, 8 months post baseline, 12 months post baseline
Quality of Life in Epilepsy-31 (QOLIE-31)
his is a 31-item self-report scale used in the seizure population to evaluate Quality of Life. The lowest possible score is 0 and the highest possible score is 100, reflecting a better quality of life.
Measured: Baseline, Weeks 6 and 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2018
- Study start15 Sep 2017
- Primary completion15 May 2022 (estimated)
- Study completion14 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Seizure DisorderStudies of the same condition, open and under way.
- 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 224 participants (actual)
Sponsor and investigators
- Lead sponsor
- Providence VA Medical Center
- Sponsor type
- US federal agency
- Collaborators
- University of Alabama at Birmingham, Rhode Island Hospital, Birmingham, Alabama VA Medical Center, United States Department of Defense, Ocean State Research Institute, Inc., Brown University
- Responsible party
- Sponsor
- Investigators
- W. Curt LaFrance, Jr., MD, MPH, Principal investigator, Providence VA Medical CenterJerzy Szarflarski, MD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03441867
- Sponsor's protocol ID
- Award Number W81XWH-17-1-0619
- Acronym
- NIBMSZS
- Status last verified
- Apr 2022
- First submitted
- 29 Dec 2017
- Last updated
- 5 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
LaFrance WC Jr, Baird GL, Barry JJ, Blum AS, Frank Webb A, Keitner GI, Machan JT, Miller I, Szaflarski JP; NES Treatment Trial (NEST-T) Consortium. Multicenter pilot treatment trial for psychogenic nonepileptic seizures: a randomized clinical trial. JAMA Psychiatry. 2014 Sep;71(9):997-1005. doi: 10.1001/jamapsychiatry.2014.817.
PubMed 24989152Salinsky M, Spencer D, Boudreau E, Ferguson F. Psychogenic nonepileptic seizures in US veterans. Neurology. 2011 Sep 6;77(10):945-50. doi: 10.1212/WNL.0b013e31822cfc46.
PubMed 21893668LaFrance WC Jr, Friedman JH. Cognitive behavioral therapy for psychogenic movement disorder. Mov Disord. 2009 Sep 15;24(12):1856-7. doi: 10.1002/mds.22683. No abstract available.
PubMed 19562779LaFrance WC Jr, Keitner GI, Papandonatos GD, Blum AS, Machan JT, Ryan CE, Miller IW. Pilot pharmacologic randomized controlled trial for psychogenic nonepileptic seizures. Neurology. 2010 Sep 28;75(13):1166-73. doi: 10.1212/WNL.0b013e3181f4d5a9. Epub 2010 Aug 25.
PubMed 20739647Reiter 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 10775516Elsas SM, Gregory WL, White G, Navarro G, Salinsky MC, Andrews DJ. Aura interruption: the Andrews/Reiter behavioral intervention may reduce seizures and improve quality of life - a pilot trial. Epilepsy Behav. 2011 Dec;22(4):765-72. doi: 10.1016/j.yebeh.2011.09.030. Epub 2011 Nov 6.
PubMed 22056814Michaelis R, Schonfeld W, Elsas SM. Trigger self-control and seizure arrest in the Andrews/Reiter behavioral approach to epilepsy: a retrospective analysis of seizure frequency. Epilepsy Behav. 2012 Mar;23(3):266-71. doi: 10.1016/j.yebeh.2011.11.023. Epub 2012 Feb 15.
PubMed 22341960Allendorfer JB, Szaflarski JP. Physiologic and cortical response to acute psychosocial stress in left temporal lobe epilepsy: response to a biochemical evaluation. Epilepsy Behav. 2014 Dec;41:312-3. doi: 10.1016/j.yebeh.2014.08.018. Epub 2014 Oct 11. No abstract available.
PubMed 25306199Szaflarski JP, Ficker DM, Cahill WT, Privitera MD. Four-year incidence of psychogenic nonepileptic seizures in adults in hamilton county, OH. Neurology. 2000 Nov 28;55(10):1561-3. doi: 10.1212/wnl.55.10.1561.
PubMed 11094115LaFrance WC Jr, Syc S. Depression and symptoms affect quality of life in psychogenic nonepileptic seizures. Neurology. 2009 Aug 4;73(5):366-71. doi: 10.1212/WNL.0b013e3181b04c83.
PubMed 19652140Szaflarski JP, Hughes C, Szaflarski M, Ficker DM, Cahill WT, Li M, Privitera MD. Quality of life in psychogenic nonepileptic seizures. Epilepsia. 2003 Feb;44(2):236-42. doi: 10.1046/j.1528-1157.2003.35302.x.
PubMed 12558580Voon V, Brezing C, Gallea C, Ameli R, Roelofs K, LaFrance WC Jr, Hallett M. Emotional stimuli and motor conversion disorder. Brain. 2010 May;133(Pt 5):1526-36. doi: 10.1093/brain/awq054. Epub 2010 Apr 5.
PubMed 20371508Van Patten R, Cotton E, Chan L, Altalib H, Tocco K, Gaston TE, Grayson LP, Martin A, Fry S, Goodman A, Allendorfer JB, Blum A, Szaflarski JP, LaFrance WC Jr. Neurobehavioral Therapy Is Associated With Improvements in Social Functioning in Patients With Functional Seizures and Traumatic Brain Injury. J Clin Psychol. 2026 Jan;82(1):84-96. doi: 10.1002/jclp.70047. Epub 2025 Sep 25.
PubMed 40996372
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuroimaging Biomarker for Seizures
- ClinicalTrials.gov ID
- NCT03441867
- Acronym / sponsor ID
- NIBMSZS / Award Number W81XWH-17-1-0619
- Conditions
- Seizure Disorder, Seizure Disorder, Post Traumatic, Traumatic Brain Injury, Non-Epileptic Seizure, Conversion Disorder, Magnetic Resonance Imaging
- Keywords
- Cognitive Behavioral Therapy, Veterans, Quality of Life, Stress Disorders, Post-Traumatic, Convulsion, Non-Epileptic, civilians, healthy volunteers
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 224 participants (actual)
- Lead sponsor
- Providence VA Medical CenterUS federal agency
- Collaborators
- University of Alabama at Birmingham, Rhode Island Hospital, Birmingham, Alabama VA Medical Center, United States Department of Defense, Ocean State Research Institute, Inc., Brown University
- Study start
- 15 Sep 2017 (actual)
- Primary completion
- 15 May 2022 (estimated)
- Study completion
- 14 Sep 2022 (estimated)
- First posted
- 22 Feb 2018 (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.
This multi-site study will examine patients with epilepsy (ES) following head injury [i.e., posttraumatic epilepsy (PTE)] and posttraumatic psychogenic Non-epileptic seizures (PNES) and will compare them to patients with traumatic brain injury (TBI) who do not have seizures using functional neuroimaging.
Detailed description
Numerous Veterans and civilians have seizures, which can be epileptic or nonepileptic in nature. Epileptic seizures are caused by abnormal brain cell firing. Nonepileptic seizures appear similar to epileptic seizures, but are associated with traumatic experiences and underlying psychological stressors. Both types of seizure are common and disabling, and many patients with seizures do not have adequate control resulting in loss of quality of life.
In this proposed 3-site study ( Providence, RI and Birmingham, AL), which are epilepsy centers with expertise both in epilepsy and psychogenic nonepileptic seizures (PNES), we will enroll 88 patients with video-EEG confirmed PNES and 88 with confirmed post-traumatic epilepsy (PTE) and will obtain functional neuroimaging before and after they receive a behavioral treatment - Cognitive Behavioral Therapy for Seizures. The functional neuroimaging studies in these patients will be compared to patients with traumatic brain injury without seizures to test the hypothesis that the faulty processing of emotions and stress in patients with PNES/PTE and abnormal brain connectivity have unique signals in patients with seizures compared to Veterans without seizures and that the neuroimaging signatures can be modified using behavioral intervention.
Impact: This grant application for the first study investigating mechanisms of PNES and PTE will provide increased understanding of neural circuitry in PTE and PNES, which can inform PTE and PNES treatments and could change clinical neurologic and psychiatric practice for PTE and PNES.
Participants will be recruited at the Providence VA Medical Center, Rhode Island Hospital, and University of Alabama, Birmingham (UAB).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| (CBT-Sz) - PNES | Experimental | Behavioral: Cognitive Behavioral Therapy for SeizuresParticipants with history of a head injury and confirmed Psychogenic Non-Epileptic Seizures will complete 2 brain fMRI scans along with 12 weeks of one hour CBT-Sz sessions by a trained therapist. |
| (CBT-Sz) - PTE | Experimental | Behavioral: Cognitive Behavioral Therapy for SeizuresParticipants with history of a head injury and confirmed Post-Traumatic Epilepsy (PTE) will complete 2 brain fMRI scans along with 12 weeks of one hour CBT-Sz sessions by a trained therapist. |
| TBI Control | Active comparator | Other: Standard Medical CareParticipants with TBI will complete 2 brain fMRI scans. |
| Healthy Volunteer | Active comparator | Other: Standard Medical CareHealthy control volunteers will complete 2 brain fMRI scans. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Inclusion criteria for PNES, ES and TBI (w/o PNES or ES) participants
- Diagnosed by video/EEG with lone PNES or by EEG with lone ES.
- Patients must have at least 1 PNES or 1 ES during the year prior to enrollment.
Key exclusion criteria (14 listed)
- Exclusion Criteria of PNES, ES and TBI (w/o PNES or ES) participants
- Inability or unwillingness to participate in CBT and assigned homework.
- Currently enrolled in cognitive therapy aimed at PNES (Current CBT or other psychotherapy may be administered).
- Concurrent mixed ES/PNES or equivocal video/EEG findings in discerning between ES and PNES will not be enrolled.
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 |
|---|---|---|
| Cognitive Behavioral Therapy for SeizuresAlso: Cognitive Behavioral Therapy (CBT-Sz), (CBT-Sz) - PNES, (CBT-Sz) - PTECBT-informed psychotherapy for patients with PNES and PTE | Behavioural | (CBT-Sz) - PNES, (CBT-Sz) - PTE |
| Standard Medical CareAlso: Treatment as UsualObservational - standard medical care | Other | Healthy Volunteer, TBI Control |
Primary outcome
Number of Epileptic Seizures
Time frame: Baseline, Weeks 1,2,3,4,5,6,7,8,9,10,11,12, 8 months post baseline, 12 months post baseline
epileptic seizure frequency (ES), collected prospectively, using a daily seizure calendar
Number of Nonepileptic Seizures (NES)
Time frame: Baseline, Weeks 1,2,3,4,5,6,7,8,9,10,11,12, 8 months post baseline, 12 months post baseline
psychogenic nonepileptic seizure (NES) frequency, collected prospectively, using a daily seizure calendar
Structural and Functional Neuroimaging
Time frame: Baseline and week 13
Brain MRI scans
3 secondary outcomes
Beck Depression Inventory-II (BDI-II)
Time frame: Baseline, Weeks 1,2,3,4,5,6,7,8,9,10,11,12, 8 months post baseline, 12 months post baseline
Beck Anxiety Inventory (BAI)
Time frame: Baseline, Weeks 6 and 10, 8 months post baseline, 12 months post baseline
Quality of Life in Epilepsy-31 (QOLIE-31)
Time frame: Baseline, Weeks 6 and 10
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2022.
- Background: PubMed 24989152LaFrance WC Jr, Baird GL, Barry JJ, Blum AS, Frank Webb A, Keitner GI, Machan JT, Miller I, Szaflarski JP; NES Treatment Trial (NEST-T) Consortium. Multicenter pilot treatment trial for psychogenic nonepileptic seizures: a randomized clinical trial. JAMA Psychiatry. 2014 Sep;71(9):997-1005. doi: 10.1001/jamapsychiatry.2014.817.
- Background: PubMed 21893668Salinsky M, Spencer D, Boudreau E, Ferguson F. Psychogenic nonepileptic seizures in US veterans. Neurology. 2011 Sep 6;77(10):945-50. doi: 10.1212/WNL.0b013e31822cfc46.
- Background: PubMed 19562779LaFrance WC Jr, Friedman JH. Cognitive behavioral therapy for psychogenic movement disorder. Mov Disord. 2009 Sep 15;24(12):1856-7. doi: 10.1002/mds.22683. No abstract available.
- Background: PubMed 20739647LaFrance WC Jr, Keitner GI, Papandonatos GD, Blum AS, Machan JT, Ryan CE, Miller IW. Pilot pharmacologic randomized controlled trial for psychogenic nonepileptic seizures. Neurology. 2010 Sep 28;75(13):1166-73. doi: 10.1212/WNL.0b013e3181f4d5a9. Epub 2010 Aug 25.
- 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.
- Background: PubMed 22056814Elsas SM, Gregory WL, White G, Navarro G, Salinsky MC, Andrews DJ. Aura interruption: the Andrews/Reiter behavioral intervention may reduce seizures and improve quality of life - a pilot trial. Epilepsy Behav. 2011 Dec;22(4):765-72. doi: 10.1016/j.yebeh.2011.09.030. Epub 2011 Nov 6.
- Background: PubMed 22341960Michaelis R, Schonfeld W, Elsas SM. Trigger self-control and seizure arrest in the Andrews/Reiter behavioral approach to epilepsy: a retrospective analysis of seizure frequency. Epilepsy Behav. 2012 Mar;23(3):266-71. doi: 10.1016/j.yebeh.2011.11.023. Epub 2012 Feb 15.
- Background: PubMed 25306199Allendorfer JB, Szaflarski JP. Physiologic and cortical response to acute psychosocial stress in left temporal lobe epilepsy: response to a biochemical evaluation. Epilepsy Behav. 2014 Dec;41:312-3. doi: 10.1016/j.yebeh.2014.08.018. Epub 2014 Oct 11. No abstract available.
- Background: PubMed 11094115Szaflarski JP, Ficker DM, Cahill WT, Privitera MD. Four-year incidence of psychogenic nonepileptic seizures in adults in hamilton county, OH. Neurology. 2000 Nov 28;55(10):1561-3. doi: 10.1212/wnl.55.10.1561.
- Background: PubMed 19652140LaFrance WC Jr, Syc S. Depression and symptoms affect quality of life in psychogenic nonepileptic seizures. Neurology. 2009 Aug 4;73(5):366-71. doi: 10.1212/WNL.0b013e3181b04c83.
- Background: PubMed 12558580Szaflarski JP, Hughes C, Szaflarski M, Ficker DM, Cahill WT, Li M, Privitera MD. Quality of life in psychogenic nonepileptic seizures. Epilepsia. 2003 Feb;44(2):236-42. doi: 10.1046/j.1528-1157.2003.35302.x.
- Background: PubMed 20371508Voon V, Brezing C, Gallea C, Ameli R, Roelofs K, LaFrance WC Jr, Hallett M. Emotional stimuli and motor conversion disorder. Brain. 2010 May;133(Pt 5):1526-36. doi: 10.1093/brain/awq054. Epub 2010 Apr 5.
- Individual participant dataSharing planned: No
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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.
W. Curt LaFrance, Jr., MD, MPH principal investigator
Providence VA Medical Center
Jerzy Szarflarski, MD principal investigator
University of Alabama at Birmingham
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Behavioral Therapy for Seizures and Standard Medical Care in people with Seizure Disorder and Seizure Disorder, Post Traumatic, run by Providence VA Medical Center at 3 sites in United States.
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 6 inclusion and 14 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 5 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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?
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?
Number of Epileptic Seizures (time frame: Baseline, Weeks 1,2,3,4,5,6,7,8,9,10,11,12, 8 months post baseline, 12 months post baseline). The study lists 3 primary outcomes in all. 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 NCT03441867, which also lists 13 linked publications.
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 5 Apr 2022.