Back to resultsTMS vs Conventional Therapy for the Treatment of Functional Neurological Non Epileptic Seizure Disorder
Primary Purpose
Psychogenic Non-Epileptic Seizure
Status
Completed
Phase
Not Applicable
Locations
Mexico
Study Type
Interventional
Intervention
Transcranial Magnetic Stimulation
Sham Transcranial Magnetic Stimulation coil
Sponsored by
About this trial
This is an interventional treatment trial for Psychogenic Non-Epileptic Seizure focused on measuring Transcranial Magnetic Stimulation, Selective Serotonin Reuptake Inhibitor, Functional Neurological Disorder
Eligibility Criteria
Inclusion Criteria:
- Patients with a diagnosis of PNES, based on the diagnostic criteria of the Diagnostic and Statistical Manual of Mental Disorders, fifth edition (DSM-5) and the ILAE, confirmed by video recording and/or V-EEG monitoring, and who have a monthly seizure frequency greater than 3.
- Patients who have a record at the institute with the diagnosis of PNES.
- Patients with an encephalic MRI.
- Patients who give their written consent to participate in the protocol.
- Patients who have not had any changes in the pharmacological treatment in the last 6 weeks.
Exclusion Criteria:
- Patients who cannot answer the scales and other clinimetric instruments.
- Patients with a history of previous or current epilepsy.
- Patients with other major neurological comorbidities (tumor, cerebrovascular event (CVE), cranioencephalic trauma (TBI)).
- Patients currently taking medications that lower the seizure threshold (Bupropion).
- Patients with psychiatric comorbidities such as psychosis/bipolar disorder/substance abuse.
- Patients with certain implanted metallic devices (pacemakers).
- Pregnant women.
Sites / Locations
- Instituto Nacional de Neurologia Y Neurocirugia Mvs
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Transcranial Magnetic Stimulation + usual treatment with SSRIs
Sham TMS coil + usual treatment with SSRIs
Arm Description
Transcranial Magnetic Stimulation + SSRIs The TMS group will be comprised of 10 patients, each subject will receive 12 sessions of low frequency (1 Hz) rTMS over right dorsolateral prefrontal cortex with a total of 1500 each session. All patients will continue with the usual treatment established by their treating physician. Those who do not have a previous pharmacological treatment will start a protocol with sertraline, which should be started at a 50 mg/day dosage.
The sham TMS coil group will be comprised of 10 patients, sham TMS stimulation will be performed with the B-65 coil, which has similar sound and scalp contact to those experienced during active stimulation. The duration of treatment will be the same as in the experimental arm. All patients will continue with the usual treatment established by their treating physician. Those who do not have a previous pharmacological treatment will start a protocol with sertraline, which should be started at a 50 mg/day dosage.
Outcomes
Primary Outcome Measures
PNES count (1/4)
Participants in both groups will registered in a specific chart, daily psychogenic non-epileptic seizure activity.
PNES count (2/4)
Participants in both groups will registered in a specific chart, daily psychogenic non-epileptic seizure activity.
PNES count (3/4)
Participants in both groups will registered in a specific chart, daily psychogenic non-epileptic seizure activity.
PNES count (4/4)
Participants in both groups will registered in a specific chart, daily psychogenic non-epileptic seizure activity.
Secondary Outcome Measures
Psychometric self-assessment scales (BDI-II) 1/4
1.0) Mood: Beck Depression Inventory-II (BDI-II)
Minimum score: 0
Maximum score: 63
1-10: These ups and downs are considered normal
11-16: Mild mood disturbance
17-20: Borderline clinical depression
21-30: Moderate depression
31-40: Severe depression
over 40: Extreme depression
*Higher scores mean a worse outcome.
Psychometric self-assessment scales (BDI-II) 2/4
1.1) Mood: Beck Depression Inventory-II (BDI-II)
Minimum score: 0
Maximum score: 63
1-10: These ups and downs are considered normal
11-16: Mild mood disturbance
17-20: Borderline clinical depression
21-30: Moderate depression
31-40: Severe depression
over 40: Extreme depression
*Higher scores mean a worse outcome.
Psychometric self-assessment scales (BDI-II) 3/4
1.2) Mood: Beck Depression Inventory-II (BDI-II)
Minimum score: 0
Maximum score: 63
1-10: These ups and downs are considered normal
11-16: Mild mood disturbance
17-20: Borderline clinical depression
21-30: Moderate depression
31-40: Severe depression
over 40: Extreme depression
*Higher scores mean a worse outcome.
Psychometric self-assessment scales (BDI-II) 4/4
1.3) Mood: Beck Depression Inventory-II (BDI-II)
Minimum score: 0
Maximum score: 63
1-10: These ups and downs are considered normal
11-16: Mild mood disturbance
17-20: Borderline clinical depression
21-30: Moderate depression
31-40: Severe depression
over 40: Extreme depression
*Higher scores mean a worse outcome.
Psychometric self-assessment scales (DES) 1/4
2.0) Dissociation : Dissociative Experience Scale (DES).
Minimum score: 0
Maximum score: 100
High levels of dissociation are indicated by scores of 30 or more, scores under 30 indicate low levels.
*Higher scores mean a worse outcome.
Psychometric self-assessment scales (DES) 2/4
2.1) Dissociation : Dissociative Experience Scale (DES).
Minimum score: 0
Maximum score: 100
High levels of dissociation are indicated by scores of 30 or more, scores under 30 indicate low levels.
*Higher scores mean a worse outcome.
Psychometric self-assessment scales (DES) 3/4
2.2) Dissociation : Dissociative Experience Scale (DES).
Minimum score: 0
Maximum score: 100
High levels of dissociation are indicated by scores of 30 or more, scores under 30 indicate low levels.
*Higher scores mean a worse outcome.
Psychometric self-assessment scales (DES) 4/4
2.3) Dissociation : Dissociative Experience Scale (DES).
Minimum score: 0
Maximum score: 100
High levels of dissociation are indicated by scores of 30 or more, scores under 30 indicate low levels.
*Higher scores mean a worse outcome.
Psychometric self-assessment scales (PTSD) 1/4
3.0) PTSD/Trauma/Resilience: PTSD Symptom Severity Scale.
Minimum score: 0
Maximum score: 80
*Higher scores mean a worse outcome.
Psychometric self-assessment scales (PTSD) 2/4
3.1) PTSD/Trauma/Resilience: PTSD Symptom Severity Scale.
Minimum score: 0
Maximum score: 80
*Higher scores mean a worse outcome.
Psychometric self-assessment scales (PTSD) 3/4
3.2) PTSD/Trauma/Resilience: PTSD Symptom Severity Scale.
Minimum score: 0
Maximum score: 80
*Higher scores mean a worse outcome.
Psychometric self-assessment scales (PTSD) 4/4
3.3) PTSD/Trauma/Resilience: PTSD Symptom Severity Scale.
Minimum score: 0
Maximum score: 80
*Higher scores mean a worse outcome.
Psychometric self-assessment scales (MoCA) 1/4
4.0) Education and Cognition: Montreal Cognitive Assessment (MoCA).
Minimum score: 0
Maximum score: 30
Normal score: 26-30
Probable Neurocognitive Dissorder: 0-25
*Higher scores mean a better outcome.
Psychometric self-assessment scales (MoCA) 2/4
4.1) Education and Cognition: Montreal Cognitive Assessment (MoCA).
Minimum score: 0
Maximum score: 30
Normal score: 26-30
Probable Neurocognitive Dissorder: 0-25
*Higher scores mean a better outcome.
Psychometric self-assessment scales (MoCA) 3/4
4.2) Education and Cognition: Montreal Cognitive Assessment (MoCA).
Minimum score: 0
Maximum score: 30
Normal score: 26-30
Probable Neurocognitive Dissorder: 0-25
*Higher scores mean a better outcome.
Psychometric self-assessment scales (MoCA) 4/4
4.3) Education and Cognition: Montreal Cognitive Assessment (MoCA).
Minimum score: 0
Maximum score: 30
Normal score: 26-30
Probable Neurocognitive Dissorder: 0-25
*Higher scores mean a better outcome.
Psychometric self-assessment scales (WHOQOL-BREF) 1/4
5.0) Quality of life: WHOQOL-BREF (World Health Organization Quality of Life-BREF).
Minimum score: 0
Maximum score: 100
*Higher scores mean a better outcome.
Psychometric self-assessment scales (WHOQOL-BREF) 2/4
5.1) Quality of life: WHOQOL-BREF (World Health Organization Quality of Life-BREF).
Minimum score: 0
Maximum score: 100
*Higher scores mean a better outcome.
Psychometric self-assessment scales (WHOQOL-BREF) 3/4
5.2) Quality of life: WHOQOL-BREF (World Health Organization Quality of Life-BREF).
Minimum score: 0
Maximum score: 100
*Higher scores mean a better outcome.
Psychometric self-assessment scales (WHOQOL-BREF) 4/4
5.3) Quality of life: WHOQOL-BREF (World Health Organization Quality of Life-BREF).
Minimum score: 0
Maximum score: 100
*Higher scores mean a better outcome.
Psychometric self-assessment scales (King's) 1/4
6.0) King's Internalized Stigma Scale.
Minimum score: 0
Maximum score: 112
*Higher scores mean a worse outcome.
Psychometric self-assessment scales (King's) 2/4
6.1) King's Internalized Stigma Scale.
Minimum score: 0
Maximum score: 112
*Higher scores mean a worse outcome.
Psychometric self-assessment scales (King's) 3/4
6.2) King's Internalized Stigma Scale.
Minimum score: 0
Maximum score: 112
*Higher scores mean a worse outcome.
Psychometric self-assessment scales (King's) 4/4
6.3) King's Internalized Stigma Scale.
Minimum score: 0
Maximum score: 112
*Higher scores mean a worse outcome.
Psychometric self-assessment scales (OCI-R) 1/4
7.0) Obsessions/compulsions: The Obsessive-Compulsive Inventory Short Version (OCI-R)
Minimum score: 0
Maximum score: 72
*Higher scores mean a worse outcome.
Psychometric self-assessment scales (OCI-R) 2/4
7.1) Obsessions/compulsions: The Obsessive-Compulsive Inventory Short Version (OCI-R)
Minimum score: 0
Maximum score: 72
*Higher scores mean a worse outcome.
Psychometric self-assessment scales (OCI-R) 3/4
7.2) Obsessions/compulsions: The Obsessive-Compulsive Inventory Short Version (OCI-R)
Minimum score: 0
Maximum score: 72
*Higher scores mean a worse outcome.
Psychometric self-assessment scales (OCI-R) 4/4
7.3) Obsessions/compulsions: The Obsessive-Compulsive Inventory Short Version (OCI-R)
Minimum score: 0
Maximum score: 72
*Higher scores mean a worse outcome.
Psychometric self-assessment scales (BAI) 1/4
8.0) Beck Anxiety Inventory (BAI).
Minimum score: 0
Maximum score: 63
Minimal: 0 - 7
Mild: 8 - 15
Moderate: 16 - 25
Severe: 26 - 63
*Higher scores mean a worse outcome.
Psychometric self-assessment scales (BAI) 2/4
8.1) Beck Anxiety Inventory (BAI).
Minimum score: 0
Maximum score: 63
Minimal: 0 - 7
Mild: 8 - 15
Moderate: 16 - 25
Severe: 26 - 63
*Higher scores mean a worse outcome.
Psychometric self-assessment scales (BAI) 3/4
8.2) Beck Anxiety Inventory (BAI).
Minimum score: 0
Maximum score: 63
Minimal: 0 - 7
Mild: 8 - 15
Moderate: 16 - 25
Severe: 26 - 63
*Higher scores mean a worse outcome.
Psychometric self-assessment scales (BAI) 4/4
8.3) Beck Anxiety Inventory (BAI).
Minimum score: 0
Maximum score: 63
Minimal: 0 - 7
Mild: 8 - 15
Moderate: 16 - 25
Severe: 26 - 63
*Higher scores mean a worse outcome.
Psychometric self-assessment scales (HADS) 1/4
9.0) Anxiety: Hospital Anxiety and Depression Scale (HADS).
Depression (D):
Minimum score: 0
Maximum score: 21
Anxiety (A):
Minimum score: 0
Maximum score: 21
*Higher scores mean a worse outcome.
Psychometric self-assessment scales (HADS) 2/4
9.1) Anxiety: Hospital Anxiety and Depression Scale (HADS).
Depression (D):
Minimum score: 0
Maximum score: 21
Anxiety (A):
Minimum score: 0
Maximum score: 21
*Higher scores mean a worse outcome.
Psychometric self-assessment scales (HADS) 3/4
9.2) Anxiety: Hospital Anxiety and Depression Scale (HADS).
Depression (D):
Minimum score: 0
Maximum score: 21
Anxiety (A):
Minimum score: 0
Maximum score: 21
*Higher scores mean a worse outcome.
Psychometric self-assessment scales (HADS) 4/4
9.3) Anxiety: Hospital Anxiety and Depression Scale (HADS).
Depression (D):
Minimum score: 0
Maximum score: 21
Anxiety (A):
Minimum score: 0
Maximum score: 21
*Higher scores mean a worse outcome.
Full Information
NCT ID
NCT05241366
First Posted
January 20, 2022
Last Updated
September 27, 2023
Sponsor
El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez
1. Study Identification
Unique Protocol Identification Number
NCT05241366
Brief Title
TMS vs Conventional Therapy for the Treatment of Functional Neurological Non Epileptic Seizure Disorder
Official Title
Controlled Clinical Trial of Transcranial Magnetic Stimulation Versus Conventional Therapy for the Treatment of Functional Neurological Non-Epileptic Seizure Disorder: A Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
February 14, 2022 (Actual)
Primary Completion Date
May 20, 2023 (Actual)
Study Completion Date
July 31, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
The aim of the study is to compare the effect of Transcranial Magnetic Stimulation (TMS) versus treatment with selective serotonin reuptake inhibitors (SSRIs), in patients with diagnosis of Functional Neurological Non Epileptic Seizure Disorder (PNES).
Detailed Description
This study consists of a single-blind Randomized Controlled Clinical Trial comprised of 20 patients with diagnosis of Psychogenic Non Epileptic Seizures (PNES), distributed in 2 arms of 10 patients each.
Patients (n=20) will be randomly assigned (using the block randomization method) to one of the groups. Both groups of patients will be receiving their usual medical treatment (SSRIs), one group will receive in addition a therapeutic scheme with active TMS, while the second group will receive the same scheme, but with a sham TMS coil to decrease the bias of placebo effect.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psychogenic Non-Epileptic Seizure
Keywords
Transcranial Magnetic Stimulation, Selective Serotonin Reuptake Inhibitor, Functional Neurological Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Single-blind randomized controlled clinical trial. Non-probabilistic sampling of consecutive cases randomized to each arm of the study. The study will consist of a control group and a study group. The study group will receive a therapeutic scheme with Transcranial Magnetic Stimulation (TMS) + usual pharmacological treatment and the control group will receive an identical scheme with TMS simulated with a sham coil + usual pharmacological treatment.
Masking
ParticipantOutcomes Assessor
Masking Description
Double masking (Trial Participant/Outcomes Assessor)
Allocation
Randomized
Enrollment
28 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Transcranial Magnetic Stimulation + usual treatment with SSRIs
Arm Type
Experimental
Arm Description
Transcranial Magnetic Stimulation + SSRIs The TMS group will be comprised of 10 patients, each subject will receive 12 sessions of low frequency (1 Hz) rTMS over right dorsolateral prefrontal cortex with a total of 1500 each session.
All patients will continue with the usual treatment established by their treating physician. Those who do not have a previous pharmacological treatment will start a protocol with sertraline, which should be started at a 50 mg/day dosage.
Arm Title
Sham TMS coil + usual treatment with SSRIs
Arm Type
Sham Comparator
Arm Description
The sham TMS coil group will be comprised of 10 patients, sham TMS stimulation will be performed with the B-65 coil, which has similar sound and scalp contact to those experienced during active stimulation. The duration of treatment will be the same as in the experimental arm.
All patients will continue with the usual treatment established by their treating physician. Those who do not have a previous pharmacological treatment will start a protocol with sertraline, which should be started at a 50 mg/day dosage.
Intervention Type
Device
Intervention Name(s)
Transcranial Magnetic Stimulation
Other Intervention Name(s)
rTMS
Intervention Description
The TMS group will be comprised of 10 patients, each subject will receive 12 sessions of low frequency (1 Hz) rTMS over the right dorsolateral prefrontal cortex with a total of 1500 pulses in each session. Each session will last approximately 30 minutes. There will be one session per day, five sessions per week. The total duration of the treatment will be four weeks.
All patients will continue with the usual treatment established by their treating physician. Those who do not have a previous pharmacological treatment will start a protocol with sertraline, which should be started at a 50 mg/day dosage.
Intervention Type
Device
Intervention Name(s)
Sham Transcranial Magnetic Stimulation coil
Other Intervention Name(s)
Sham TMS coil
Intervention Description
Simulated TMS stimulation will be performed with a Sham TMS coil, which has a sound and scalp contact similar to those experienced during active stimulation. The duration of the treatment will be the same as in the experimental arm.
All patients will continue with the usual treatment established by their treating physician. Those who do not have a previous pharmacological treatment will start a protocol with sertraline, which should be started at a 50 mg/day dosage.
Primary Outcome Measure Information:
Title
PNES count (1/4)
Description
Participants in both groups will registered in a specific chart, daily psychogenic non-epileptic seizure activity.
Time Frame
Baseline PNES count (Starting 1 month before TMS treatment)
Title
PNES count (2/4)
Description
Participants in both groups will registered in a specific chart, daily psychogenic non-epileptic seizure activity.
Time Frame
Change from Baseline PNES count (immediately after the session 12th -last session-)
Title
PNES count (3/4)
Description
Participants in both groups will registered in a specific chart, daily psychogenic non-epileptic seizure activity.
Time Frame
Change from Baseline PNES count at month 1 post treatment
Title
PNES count (4/4)
Description
Participants in both groups will registered in a specific chart, daily psychogenic non-epileptic seizure activity.
Time Frame
Change from Baseline PNES count at month 2 post treatment
Secondary Outcome Measure Information:
Title
Psychometric self-assessment scales (BDI-II) 1/4
Description
1.0) Mood: Beck Depression Inventory-II (BDI-II)
Minimum score: 0
Maximum score: 63
1-10: These ups and downs are considered normal
11-16: Mild mood disturbance
17-20: Borderline clinical depression
21-30: Moderate depression
31-40: Severe depression
over 40: Extreme depression
*Higher scores mean a worse outcome.
Time Frame
Baseline score (1 month before TMS treatment)
Title
Psychometric self-assessment scales (BDI-II) 2/4
Description
1.1) Mood: Beck Depression Inventory-II (BDI-II)
Minimum score: 0
Maximum score: 63
1-10: These ups and downs are considered normal
11-16: Mild mood disturbance
17-20: Borderline clinical depression
21-30: Moderate depression
31-40: Severe depression
over 40: Extreme depression
*Higher scores mean a worse outcome.
Time Frame
Change from Baseline score (immediately after the 12th session -last session-)
Title
Psychometric self-assessment scales (BDI-II) 3/4
Description
1.2) Mood: Beck Depression Inventory-II (BDI-II)
Minimum score: 0
Maximum score: 63
1-10: These ups and downs are considered normal
11-16: Mild mood disturbance
17-20: Borderline clinical depression
21-30: Moderate depression
31-40: Severe depression
over 40: Extreme depression
*Higher scores mean a worse outcome.
Time Frame
Change from Baseline score at month 1 post treatment
Title
Psychometric self-assessment scales (BDI-II) 4/4
Description
1.3) Mood: Beck Depression Inventory-II (BDI-II)
Minimum score: 0
Maximum score: 63
1-10: These ups and downs are considered normal
11-16: Mild mood disturbance
17-20: Borderline clinical depression
21-30: Moderate depression
31-40: Severe depression
over 40: Extreme depression
*Higher scores mean a worse outcome.
Time Frame
Change from Baseline score at month 2 post treatment
Title
Psychometric self-assessment scales (DES) 1/4
Description
2.0) Dissociation : Dissociative Experience Scale (DES).
Minimum score: 0
Maximum score: 100
High levels of dissociation are indicated by scores of 30 or more, scores under 30 indicate low levels.
*Higher scores mean a worse outcome.
Time Frame
Baseline score (1 month before TMS treatment)
Title
Psychometric self-assessment scales (DES) 2/4
Description
2.1) Dissociation : Dissociative Experience Scale (DES).
Minimum score: 0
Maximum score: 100
High levels of dissociation are indicated by scores of 30 or more, scores under 30 indicate low levels.
*Higher scores mean a worse outcome.
Time Frame
Change from Baseline score (immediately after the 12th session -last session-)
Title
Psychometric self-assessment scales (DES) 3/4
Description
2.2) Dissociation : Dissociative Experience Scale (DES).
Minimum score: 0
Maximum score: 100
High levels of dissociation are indicated by scores of 30 or more, scores under 30 indicate low levels.
*Higher scores mean a worse outcome.
Time Frame
Change from Baseline score at month 1 post treatment
Title
Psychometric self-assessment scales (DES) 4/4
Description
2.3) Dissociation : Dissociative Experience Scale (DES).
Minimum score: 0
Maximum score: 100
High levels of dissociation are indicated by scores of 30 or more, scores under 30 indicate low levels.
*Higher scores mean a worse outcome.
Time Frame
Change from Baseline score at month 2 post treatment
Title
Psychometric self-assessment scales (PTSD) 1/4
Description
3.0) PTSD/Trauma/Resilience: PTSD Symptom Severity Scale.
Minimum score: 0
Maximum score: 80
*Higher scores mean a worse outcome.
Time Frame
Baseline score (1 month before TMS treatment)
Title
Psychometric self-assessment scales (PTSD) 2/4
Description
3.1) PTSD/Trauma/Resilience: PTSD Symptom Severity Scale.
Minimum score: 0
Maximum score: 80
*Higher scores mean a worse outcome.
Time Frame
Change from Baseline score (immediately after the 12th session -last session-)
Title
Psychometric self-assessment scales (PTSD) 3/4
Description
3.2) PTSD/Trauma/Resilience: PTSD Symptom Severity Scale.
Minimum score: 0
Maximum score: 80
*Higher scores mean a worse outcome.
Time Frame
Change from Baseline score at month 1 post treatment
Title
Psychometric self-assessment scales (PTSD) 4/4
Description
3.3) PTSD/Trauma/Resilience: PTSD Symptom Severity Scale.
Minimum score: 0
Maximum score: 80
*Higher scores mean a worse outcome.
Time Frame
Change from Baseline score at month 2 post treatment
Title
Psychometric self-assessment scales (MoCA) 1/4
Description
4.0) Education and Cognition: Montreal Cognitive Assessment (MoCA).
Minimum score: 0
Maximum score: 30
Normal score: 26-30
Probable Neurocognitive Dissorder: 0-25
*Higher scores mean a better outcome.
Time Frame
Baseline score (1 month before TMS treatment)
Title
Psychometric self-assessment scales (MoCA) 2/4
Description
4.1) Education and Cognition: Montreal Cognitive Assessment (MoCA).
Minimum score: 0
Maximum score: 30
Normal score: 26-30
Probable Neurocognitive Dissorder: 0-25
*Higher scores mean a better outcome.
Time Frame
Change from Baseline score (immediately after the 12th session -last session-)
Title
Psychometric self-assessment scales (MoCA) 3/4
Description
4.2) Education and Cognition: Montreal Cognitive Assessment (MoCA).
Minimum score: 0
Maximum score: 30
Normal score: 26-30
Probable Neurocognitive Dissorder: 0-25
*Higher scores mean a better outcome.
Time Frame
Change from Baseline score at month 1 post treatment
Title
Psychometric self-assessment scales (MoCA) 4/4
Description
4.3) Education and Cognition: Montreal Cognitive Assessment (MoCA).
Minimum score: 0
Maximum score: 30
Normal score: 26-30
Probable Neurocognitive Dissorder: 0-25
*Higher scores mean a better outcome.
Time Frame
Change from Baseline score at month 2 post treatment
Title
Psychometric self-assessment scales (WHOQOL-BREF) 1/4
Description
5.0) Quality of life: WHOQOL-BREF (World Health Organization Quality of Life-BREF).
Minimum score: 0
Maximum score: 100
*Higher scores mean a better outcome.
Time Frame
Baseline score (1 month before TMS treatment)
Title
Psychometric self-assessment scales (WHOQOL-BREF) 2/4
Description
5.1) Quality of life: WHOQOL-BREF (World Health Organization Quality of Life-BREF).
Minimum score: 0
Maximum score: 100
*Higher scores mean a better outcome.
Time Frame
Change from Baseline score (immediately after the 12th session -last session-)
Title
Psychometric self-assessment scales (WHOQOL-BREF) 3/4
Description
5.2) Quality of life: WHOQOL-BREF (World Health Organization Quality of Life-BREF).
Minimum score: 0
Maximum score: 100
*Higher scores mean a better outcome.
Time Frame
Change from Baseline score at month 1 post treatment
Title
Psychometric self-assessment scales (WHOQOL-BREF) 4/4
Description
5.3) Quality of life: WHOQOL-BREF (World Health Organization Quality of Life-BREF).
Minimum score: 0
Maximum score: 100
*Higher scores mean a better outcome.
Time Frame
Change from Baseline score at month 2 post treatment
Title
Psychometric self-assessment scales (King's) 1/4
Description
6.0) King's Internalized Stigma Scale.
Minimum score: 0
Maximum score: 112
*Higher scores mean a worse outcome.
Time Frame
Baseline score (1 month before TMS treatment)
Title
Psychometric self-assessment scales (King's) 2/4
Description
6.1) King's Internalized Stigma Scale.
Minimum score: 0
Maximum score: 112
*Higher scores mean a worse outcome.
Time Frame
Change from Baseline score (immediately after the 12th session -last session-)
Title
Psychometric self-assessment scales (King's) 3/4
Description
6.2) King's Internalized Stigma Scale.
Minimum score: 0
Maximum score: 112
*Higher scores mean a worse outcome.
Time Frame
Change from Baseline score at month 1 post treatment
Title
Psychometric self-assessment scales (King's) 4/4
Description
6.3) King's Internalized Stigma Scale.
Minimum score: 0
Maximum score: 112
*Higher scores mean a worse outcome.
Time Frame
Change from Baseline score at month 2 post treatment
Title
Psychometric self-assessment scales (OCI-R) 1/4
Description
7.0) Obsessions/compulsions: The Obsessive-Compulsive Inventory Short Version (OCI-R)
Minimum score: 0
Maximum score: 72
*Higher scores mean a worse outcome.
Time Frame
Baseline score (1 month before TMS treatment)
Title
Psychometric self-assessment scales (OCI-R) 2/4
Description
7.1) Obsessions/compulsions: The Obsessive-Compulsive Inventory Short Version (OCI-R)
Minimum score: 0
Maximum score: 72
*Higher scores mean a worse outcome.
Time Frame
Change from Baseline score (immediately after the 12th session -last session-)
Title
Psychometric self-assessment scales (OCI-R) 3/4
Description
7.2) Obsessions/compulsions: The Obsessive-Compulsive Inventory Short Version (OCI-R)
Minimum score: 0
Maximum score: 72
*Higher scores mean a worse outcome.
Time Frame
Change from Baseline score at month 1 post treatment
Title
Psychometric self-assessment scales (OCI-R) 4/4
Description
7.3) Obsessions/compulsions: The Obsessive-Compulsive Inventory Short Version (OCI-R)
Minimum score: 0
Maximum score: 72
*Higher scores mean a worse outcome.
Time Frame
Change from Baseline score at month 2 post treatment
Title
Psychometric self-assessment scales (BAI) 1/4
Description
8.0) Beck Anxiety Inventory (BAI).
Minimum score: 0
Maximum score: 63
Minimal: 0 - 7
Mild: 8 - 15
Moderate: 16 - 25
Severe: 26 - 63
*Higher scores mean a worse outcome.
Time Frame
Baseline score (1 month before TMS treatment)
Title
Psychometric self-assessment scales (BAI) 2/4
Description
8.1) Beck Anxiety Inventory (BAI).
Minimum score: 0
Maximum score: 63
Minimal: 0 - 7
Mild: 8 - 15
Moderate: 16 - 25
Severe: 26 - 63
*Higher scores mean a worse outcome.
Time Frame
Change from Baseline score (immediately after the 12th session -last session-)
Title
Psychometric self-assessment scales (BAI) 3/4
Description
8.2) Beck Anxiety Inventory (BAI).
Minimum score: 0
Maximum score: 63
Minimal: 0 - 7
Mild: 8 - 15
Moderate: 16 - 25
Severe: 26 - 63
*Higher scores mean a worse outcome.
Time Frame
Change from Baseline score at month 1 post treatment
Title
Psychometric self-assessment scales (BAI) 4/4
Description
8.3) Beck Anxiety Inventory (BAI).
Minimum score: 0
Maximum score: 63
Minimal: 0 - 7
Mild: 8 - 15
Moderate: 16 - 25
Severe: 26 - 63
*Higher scores mean a worse outcome.
Time Frame
Change from Baseline score at month 2 post treatment
Title
Psychometric self-assessment scales (HADS) 1/4
Description
9.0) Anxiety: Hospital Anxiety and Depression Scale (HADS).
Depression (D):
Minimum score: 0
Maximum score: 21
Anxiety (A):
Minimum score: 0
Maximum score: 21
*Higher scores mean a worse outcome.
Time Frame
Baseline score (1 month before TMS treatment)
Title
Psychometric self-assessment scales (HADS) 2/4
Description
9.1) Anxiety: Hospital Anxiety and Depression Scale (HADS).
Depression (D):
Minimum score: 0
Maximum score: 21
Anxiety (A):
Minimum score: 0
Maximum score: 21
*Higher scores mean a worse outcome.
Time Frame
Change from Baseline score (immediately after the 12th session -last session-)
Title
Psychometric self-assessment scales (HADS) 3/4
Description
9.2) Anxiety: Hospital Anxiety and Depression Scale (HADS).
Depression (D):
Minimum score: 0
Maximum score: 21
Anxiety (A):
Minimum score: 0
Maximum score: 21
*Higher scores mean a worse outcome.
Time Frame
Change from Baseline score at month 1 post treatment
Title
Psychometric self-assessment scales (HADS) 4/4
Description
9.3) Anxiety: Hospital Anxiety and Depression Scale (HADS).
Depression (D):
Minimum score: 0
Maximum score: 21
Anxiety (A):
Minimum score: 0
Maximum score: 21
*Higher scores mean a worse outcome.
Time Frame
Change from Baseline score at month 2 post treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with a diagnosis of PNES, based on the diagnostic criteria of the Diagnostic and Statistical Manual of Mental Disorders, fifth edition (DSM-5) and the ILAE, confirmed by video recording and/or V-EEG monitoring, and who have a monthly seizure frequency greater than 3.
Patients who have a record at the institute with the diagnosis of PNES.
Patients with an encephalic MRI.
Patients who give their written consent to participate in the protocol.
Patients who have not had any changes in the pharmacological treatment in the last 6 weeks.
Exclusion Criteria:
Patients who cannot answer the scales and other clinimetric instruments.
Patients with a history of previous or current epilepsy.
Patients with other major neurological comorbidities (tumor, cerebrovascular event (CVE), cranioencephalic trauma (TBI)).
Patients currently taking medications that lower the seizure threshold (Bupropion).
Patients with psychiatric comorbidities such as psychosis/bipolar disorder/substance abuse.
Patients with certain implanted metallic devices (pacemakers).
Pregnant women.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Édgar Daniel Crail Meléndez, MD
Organizational Affiliation
Instituto Nacional de Neurología y Neurocirugía Manuel Velasco Suárez
Official's Role
Principal Investigator
Facility Information:
Facility Name
Instituto Nacional de Neurologia Y Neurocirugia Mvs
City
Mexico
State/Province
Ciudad De Mexico
ZIP/Postal Code
14269
Country
Mexico
12. IPD Sharing Statement
Plan to Share IPD
No
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TMS vs Conventional Therapy for the Treatment of Functional Neurological Non Epileptic Seizure Disorder
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