Clinical trial NCT05241366: 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
Overall status: COMPLETED
Phase: NA
Conditions: Psychogenic Non-Epileptic Seizure
Keywords: Transcranial Magnetic Stimulation
Selective Serotonin Reuptake Inhibitor
Functional Neurological Disorder
Lead sponsor: El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez
Sponsor class: OTHER
First posted: 2022-02-15
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. 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.
2. Patients who have a record at the institute with the diagnosis of PNES.
3. Patients with an encephalic MRI.
4. Patients who give their written consent to participate in the protocol.
5. Patients who have not had any changes in the pharmacological treatment in the last 6 weeks.

Exclusion Criteria:

1. Patients who cannot answer the scales and other clinimetric instruments.
2. Patients with a history of previous or current epilepsy.
3. Patients with other major neurological comorbidities (tumor, cerebrovascular event (CVE), cranioencephalic trauma (TBI)).
4. Patients currently taking medications that lower the seizure threshold (Bupropion).
5. Patients with psychiatric comorbidities such as psychosis/bipolar disorder/substance abuse.
6. Patients with certain implanted metallic devices (pacemakers).
7. Pregnant women.

Primary outcomes:
measure: PNES count (1/4)
timeFrame: Baseline PNES count (Starting 1 month before TMS treatment)
measure: PNES count (2/4)
timeFrame: Change from Baseline PNES count (immediately after the session 12th -last session-)
measure: PNES count (3/4)
timeFrame: Change from Baseline PNES count at month 1 post treatment
measure: PNES count (4/4)
timeFrame: Change from Baseline PNES count at month 2 post treatment
Secondary outcomes:
measure: Psychometric self-assessment scales (BDI-II) 1/4
timeFrame: Baseline score (1 month before TMS treatment)
measure: Psychometric self-assessment scales (BDI-II) 2/4
timeFrame: Change from Baseline score (immediately after the 12th session -last session-)
measure: Psychometric self-assessment scales (BDI-II) 3/4
timeFrame: Change from Baseline score at month 1 post treatment
measure: Psychometric self-assessment scales (BDI-II) 4/4
timeFrame: Change from Baseline score at month 2 post treatment
measure: Psychometric self-assessment scales (DES) 1/4
timeFrame: Baseline score (1 month before TMS treatment)
measure: Psychometric self-assessment scales (DES) 2/4
timeFrame: Change from Baseline score (immediately after the 12th session -last session-)
measure: Psychometric self-assessment scales (DES) 3/4
timeFrame: Change from Baseline score at month 1 post treatment
measure: Psychometric self-assessment scales (DES) 4/4
timeFrame: Change from Baseline score at month 2 post treatment
measure: Psychometric self-assessment scales (PTSD) 1/4
timeFrame: Baseline score (1 month before TMS treatment)
measure: Psychometric self-assessment scales (PTSD) 2/4
timeFrame: Change from Baseline score (immediately after the 12th session -last session-)
measure: Psychometric self-assessment scales (PTSD) 3/4
timeFrame: Change from Baseline score at month 1 post treatment
measure: Psychometric self-assessment scales (PTSD) 4/4
timeFrame: Change from Baseline score at month 2 post treatment
measure: Psychometric self-assessment scales (MoCA) 1/4
timeFrame: Baseline score (1 month before TMS treatment)
measure: Psychometric self-assessment scales (MoCA) 2/4
timeFrame: Change from Baseline score (immediately after the 12th session -last session-)
measure: Psychometric self-assessment scales (MoCA) 3/4
timeFrame: Change from Baseline score at month 1 post treatment
measure: Psychometric self-assessment scales (MoCA) 4/4
timeFrame: Change from Baseline score at month 2 post treatment
measure: Psychometric self-assessment scales (WHOQOL-BREF) 1/4
timeFrame: Baseline score (1 month before TMS treatment)
measure: Psychometric self-assessment scales (WHOQOL-BREF) 2/4
timeFrame: Change from Baseline score (immediately after the 12th session -last session-)
measure: Psychometric self-assessment scales (WHOQOL-BREF) 3/4
timeFrame: Change from Baseline score at month 1 post treatment
measure: Psychometric self-assessment scales (WHOQOL-BREF) 4/4
timeFrame: Change from Baseline score at month 2 post treatment
measure: Psychometric self-assessment scales (King's) 1/4
timeFrame: Baseline score (1 month before TMS treatment)
measure: Psychometric self-assessment scales (King's) 2/4
timeFrame: Change from Baseline score (immediately after the 12th session -last session-)
measure: Psychometric self-assessment scales (King's) 3/4
timeFrame: Change from Baseline score at month 1 post treatment
measure: Psychometric self-assessment scales (King's) 4/4
timeFrame: Change from Baseline score at month 2 post treatment
measure: Psychometric self-assessment scales (OCI-R) 1/4
timeFrame: Baseline score (1 month before TMS treatment)
measure: Psychometric self-assessment scales (OCI-R) 2/4
timeFrame: Change from Baseline score (immediately after the 12th session -last session-)
measure: Psychometric self-assessment scales (OCI-R) 3/4
timeFrame: Change from Baseline score at month 1 post treatment
measure: Psychometric self-assessment scales (OCI-R) 4/4
timeFrame: Change from Baseline score at month 2 post treatment
measure: Psychometric self-assessment scales (BAI) 1/4
timeFrame: Baseline score (1 month before TMS treatment)
measure: Psychometric self-assessment scales (BAI) 2/4
timeFrame: Change from Baseline score (immediately after the 12th session -last session-)
measure: Psychometric self-assessment scales (BAI) 3/4
timeFrame: Change from Baseline score at month 1 post treatment
measure: Psychometric self-assessment scales (BAI) 4/4
timeFrame: Change from Baseline score at month 2 post treatment
measure: Psychometric self-assessment scales (HADS) 1/4
timeFrame: Baseline score (1 month before TMS treatment)
measure: Psychometric self-assessment scales (HADS) 2/4
timeFrame: Change from Baseline score (immediately after the 12th session -last session-)
measure: Psychometric self-assessment scales (HADS) 3/4
timeFrame: Change from Baseline score at month 1 post treatment
measure: Psychometric self-assessment scales (HADS) 4/4
timeFrame: Change from Baseline score at month 2 post treatment
Other outcomes:
Locations:
city: Mexico
country: Mexico
facility: Instituto Nacional de Neurologia Y Neurocirugia Mvs
state: Ciudad De Mexico
Study officials:
affiliation: Instituto Nacional de Neurología y Neurocirugía Manuel Velasco Suárez
name: Édgar Daniel Crail Meléndez, MD
role: PRINCIPAL_INVESTIGATOR
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