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Completed

NCT Number: NCT05241366

TMS vs Conventional Therapy for the Treatment of Functional Neurological Non Epileptic Seizure Disorder

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).

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Key information

Conditions

Psychogenic Non-Epileptic Seizure Conversion Disorder Mental Disorders Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Psychogenic Nonepileptic Seizures Seizures Signs and Symptoms Somatoform Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Instituto Nacional de Neurologia Y Neurocirugia Mvs

Mexico City, 14269, Mexico

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Transcranial Magnetic Stimulation

Device

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.

Other names: rTMS

Sham Transcranial Magnetic Stimulation coil

Device

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.

Other names: Sham TMS coil

Primary outcomes

  1. PNES count (1/4)

    Time frame: Baseline PNES count (Starting 1 month before TMS treatment)

    Participants in both groups will registered in a specific chart, daily psychogenic non-epileptic seizure activity.

  2. PNES count (2/4)

    Time frame: Change from Baseline PNES count (immediately after the session 12th -last session-)

    Participants in both groups will registered in a specific chart, daily psychogenic non-epileptic seizure activity.

  3. PNES count (3/4)

    Time frame: Change from Baseline PNES count at month 1 post treatment

    Participants in both groups will registered in a specific chart, daily psychogenic non-epileptic seizure activity.

  4. PNES count (4/4)

    Time frame: Change from Baseline PNES count at month 2 post treatment

    Participants in both groups will registered in a specific chart, daily psychogenic non-epileptic seizure activity.

Secondary outcomes

  1. Psychometric self-assessment scales (BDI-II) 1/4

    Time frame: Baseline score (1 month before TMS treatment)

    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.

  2. Psychometric self-assessment scales (BDI-II) 2/4

    Time frame: Change from Baseline score (immediately after the 12th session -last session-)

    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.

  3. Psychometric self-assessment scales (BDI-II) 3/4

    Time frame: Change from Baseline score at month 1 post treatment

    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.

  4. Psychometric self-assessment scales (BDI-II) 4/4

    Time frame: Change from Baseline score at month 2 post treatment

    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.

  5. Psychometric self-assessment scales (DES) 1/4

    Time frame: Baseline score (1 month before TMS treatment)

    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.

  6. Psychometric self-assessment scales (DES) 2/4

    Time frame: Change from Baseline score (immediately after the 12th session -last session-)

    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.

  7. Psychometric self-assessment scales (DES) 3/4

    Time frame: Change from Baseline score at month 1 post treatment

    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.

  8. Psychometric self-assessment scales (DES) 4/4

    Time frame: Change from Baseline score at month 2 post treatment

    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.

  9. Psychometric self-assessment scales (PTSD) 1/4

    Time frame: Baseline score (1 month before TMS treatment)

    3.0) PTSD/Trauma/Resilience: PTSD Symptom Severity Scale.

    Minimum score: 0

    Maximum score: 80

    *Higher scores mean a worse outcome.

  10. Psychometric self-assessment scales (PTSD) 2/4

    Time frame: Change from Baseline score (immediately after the 12th session -last session-)

    3.1) PTSD/Trauma/Resilience: PTSD Symptom Severity Scale.

    Minimum score: 0

    Maximum score: 80

    *Higher scores mean a worse outcome.

  11. Psychometric self-assessment scales (PTSD) 3/4

    Time frame: Change from Baseline score at month 1 post treatment

    3.2) PTSD/Trauma/Resilience: PTSD Symptom Severity Scale.

    Minimum score: 0

    Maximum score: 80

    *Higher scores mean a worse outcome.

  12. Psychometric self-assessment scales (PTSD) 4/4

    Time frame: Change from Baseline score at month 2 post treatment

    3.3) PTSD/Trauma/Resilience: PTSD Symptom Severity Scale.

    Minimum score: 0

    Maximum score: 80

    *Higher scores mean a worse outcome.

  13. Psychometric self-assessment scales (MoCA) 1/4

    Time frame: Baseline score (1 month before TMS treatment)

    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.

  14. Psychometric self-assessment scales (MoCA) 2/4

    Time frame: Change from Baseline score (immediately after the 12th session -last session-)

    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.

  15. Psychometric self-assessment scales (MoCA) 3/4

    Time frame: Change from Baseline score at month 1 post treatment

    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.

  16. Psychometric self-assessment scales (MoCA) 4/4

    Time frame: Change from Baseline score at month 2 post treatment

    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.

  17. Psychometric self-assessment scales (WHOQOL-BREF) 1/4

    Time frame: Baseline score (1 month before TMS treatment)

    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.

  18. Psychometric self-assessment scales (WHOQOL-BREF) 2/4

    Time frame: Change from Baseline score (immediately after the 12th session -last session-)

    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.

  19. Psychometric self-assessment scales (WHOQOL-BREF) 3/4

    Time frame: Change from Baseline score at month 1 post treatment

    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.

  20. Psychometric self-assessment scales (WHOQOL-BREF) 4/4

    Time frame: Change from Baseline score at month 2 post treatment

    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.

  21. Psychometric self-assessment scales (King's) 1/4

    Time frame: Baseline score (1 month before TMS treatment)

    6.0) King's Internalized Stigma Scale.

    Minimum score: 0

    Maximum score: 112

    *Higher scores mean a worse outcome.

  22. Psychometric self-assessment scales (King's) 2/4

    Time frame: Change from Baseline score (immediately after the 12th session -last session-)

    6.1) King's Internalized Stigma Scale.

    Minimum score: 0

    Maximum score: 112

    *Higher scores mean a worse outcome.

  23. Psychometric self-assessment scales (King's) 3/4

    Time frame: Change from Baseline score at month 1 post treatment

    6.2) King's Internalized Stigma Scale.

    Minimum score: 0

    Maximum score: 112

    *Higher scores mean a worse outcome.

  24. Psychometric self-assessment scales (King's) 4/4

    Time frame: Change from Baseline score at month 2 post treatment

    6.3) King's Internalized Stigma Scale.

    Minimum score: 0

    Maximum score: 112

    *Higher scores mean a worse outcome.

  25. Psychometric self-assessment scales (OCI-R) 1/4

    Time frame: Baseline score (1 month before TMS treatment)

    7.0) Obsessions/compulsions: The Obsessive-Compulsive Inventory Short Version (OCI-R)

    Minimum score: 0

    Maximum score: 72

    *Higher scores mean a worse outcome.

  26. Psychometric self-assessment scales (OCI-R) 2/4

    Time frame: Change from Baseline score (immediately after the 12th session -last session-)

    7.1) Obsessions/compulsions: The Obsessive-Compulsive Inventory Short Version (OCI-R)

    Minimum score: 0

    Maximum score: 72

    *Higher scores mean a worse outcome.

  27. Psychometric self-assessment scales (OCI-R) 3/4

    Time frame: Change from Baseline score at month 1 post treatment

    7.2) Obsessions/compulsions: The Obsessive-Compulsive Inventory Short Version (OCI-R)

    Minimum score: 0

    Maximum score: 72

    *Higher scores mean a worse outcome.

  28. Psychometric self-assessment scales (OCI-R) 4/4

    Time frame: Change from Baseline score at month 2 post treatment

    7.3) Obsessions/compulsions: The Obsessive-Compulsive Inventory Short Version (OCI-R)

    Minimum score: 0

    Maximum score: 72

    *Higher scores mean a worse outcome.

  29. Psychometric self-assessment scales (BAI) 1/4

    Time frame: Baseline score (1 month before TMS treatment)

    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.

  30. Psychometric self-assessment scales (BAI) 2/4

    Time frame: Change from Baseline score (immediately after the 12th session -last session-)

    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.

  31. Psychometric self-assessment scales (BAI) 3/4

    Time frame: Change from Baseline score at month 1 post treatment

    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.

  32. Psychometric self-assessment scales (BAI) 4/4

    Time frame: Change from Baseline score at month 2 post treatment

    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.

  33. Psychometric self-assessment scales (HADS) 1/4

    Time frame: Baseline score (1 month before TMS treatment)

    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.

  34. Psychometric self-assessment scales (HADS) 2/4

    Time frame: Change from Baseline score (immediately after the 12th session -last session-)

    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.

  35. Psychometric self-assessment scales (HADS) 3/4

    Time frame: Change from Baseline score at month 1 post treatment

    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.

  36. Psychometric self-assessment scales (HADS) 4/4

    Time frame: Change from Baseline score at month 2 post treatment

    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.

Sponsors and collaborators

Lead sponsor

El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez

Other

Registry information

Official study title

Controlled Clinical Trial of Transcranial Magnetic Stimulation Versus Conventional Therapy for the Treatment of Functional Neurological Non-Epileptic Seizure Disorder: A Pilot Study

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Feb 15, 2022
Registry last updated
Sep 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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