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).
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
28
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.
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.
Instituto Nacional de Neurologia Y Neurocirugia Mvs
Mexico City, Mexico City, Mexico
PNES count (1/4)
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)
PNES count (2/4)
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-)
PNES count (3/4)
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
PNES count (4/4)
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
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.
Time frame: Baseline score (1 month before TMS treatment)
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.
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Time frame: Change from Baseline score (immediately after the 12th session -last session-)
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.
Time frame: Change from Baseline score at month 1 post treatment
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.
Time frame: Change from Baseline score at month 2 post treatment
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.
Time frame: Baseline score (1 month before TMS treatment)
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.
Time frame: Change from Baseline score (immediately after the 12th session -last session-)
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.
Time frame: Change from Baseline score at month 1 post treatment
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.
Time frame: Change from Baseline score at month 2 post treatment
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.
Time frame: Baseline score (1 month before TMS treatment)
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.
Time frame: Change from Baseline score (immediately after the 12th session -last session-)
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.
Time frame: Change from Baseline score at month 1 post treatment
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.
Time frame: Change from Baseline score at month 2 post treatment
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.
Time frame: Baseline score (1 month before TMS treatment)
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.
Time frame: Change from Baseline score (immediately after the 12th session -last session-)
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.
Time frame: Change from Baseline score at month 1 post treatment
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.
Time frame: Change from Baseline score at month 2 post treatment
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.
Time frame: Baseline score (1 month before TMS treatment)
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.
Time frame: Change from Baseline score (immediately after the 12th session -last session-)
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.
Time frame: Change from Baseline score at month 1 post treatment
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.
Time frame: Change from Baseline score at month 2 post treatment
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.
Time frame: Baseline score (1 month before TMS treatment)
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.
Time frame: Change from Baseline score (immediately after the 12th session -last session-)
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.
Time frame: Change from Baseline score at month 1 post treatment
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.
Time frame: Change from Baseline score at month 2 post treatment
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.
Time frame: Baseline score (1 month before TMS treatment)
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.
Time frame: Change from Baseline score (immediately after the 12th session -last session-)
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.
Time frame: Change from Baseline score at month 1 post treatment
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.
Time frame: Change from Baseline score at month 2 post treatment
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.
Time frame: Baseline score (1 month before TMS treatment)
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.
Time frame: Change from Baseline score (immediately after the 12th session -last session-)
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.
Time frame: Change from Baseline score at month 1 post treatment
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.
Time frame: Change from Baseline score at month 2 post treatment
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.
Time frame: Baseline score (1 month before TMS treatment)
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.
Time frame: Change from Baseline score (immediately after the 12th session -last session-)
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.
Time frame: Change from Baseline score at month 1 post treatment
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.
Time frame: Change from Baseline score at month 2 post treatment