Controlled Clinical Trial of Transcranial Magnetic Stimulation Versus Conventional Therapy for the Treatment of Functional Neurological Non-Epileptic Seizure Disorder: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 28
- 试验地点
- 2
- 主要终点
- PNES count (2/4)
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Double masking (Trial Participant/Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •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.
排除标准
- •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.
结局指标
主要结局
PNES count (2/4)
时间窗: 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.
PNES count (4/4)
时间窗: 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.
PNES count (1/4)
时间窗: 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.
PNES count (3/4)
时间窗: 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.
次要结局
- Psychometric self-assessment scales (BDI-II) 3/4(Change from Baseline score at month 1 post treatment)
- Psychometric self-assessment scales (DES) 3/4(Change from Baseline score at month 1 post treatment)
- Psychometric self-assessment scales (WHOQOL-BREF) 3/4(Change from Baseline score at month 1 post treatment)
- Psychometric self-assessment scales (OCI-R) 4/4(Change from Baseline score at month 2 post treatment)
- Psychometric self-assessment scales (BAI) 1/4(Baseline score (1 month before TMS treatment))
- Psychometric self-assessment scales (DES) 1/4(Baseline score (1 month before TMS treatment))
- Psychometric self-assessment scales (PTSD) 3/4(Change from Baseline score at month 1 post treatment)
- Psychometric self-assessment scales (WHOQOL-BREF) 2/4(Change from Baseline score (immediately after the 12th session -last session-))
- Psychometric self-assessment scales (King's) 3/4(Change from Baseline score at month 1 post treatment)
- Psychometric self-assessment scales (BDI-II) 1/4(Baseline score (1 month before TMS treatment))
- Psychometric self-assessment scales (BDI-II) 4/4(Change from Baseline score at month 2 post treatment)
- Psychometric self-assessment scales (MoCA) 1/4(Baseline score (1 month before TMS treatment))
- Psychometric self-assessment scales (WHOQOL-BREF) 1/4(Baseline score (1 month before TMS treatment))
- Psychometric self-assessment scales (WHOQOL-BREF) 4/4(Change from Baseline score at month 2 post treatment)
- Psychometric self-assessment scales (OCI-R) 1/4(Baseline score (1 month before TMS treatment))
- Psychometric self-assessment scales (OCI-R) 3/4(Change from Baseline score at month 1 post treatment)
- Psychometric self-assessment scales (DES) 2/4(Change from Baseline score (immediately after the 12th session -last session-))
- Psychometric self-assessment scales (DES) 4/4(Change from Baseline score at month 2 post treatment)
- Psychometric self-assessment scales (PTSD) 2/4(Change from Baseline score (immediately after the 12th session -last session-))
- Psychometric self-assessment scales (BDI-II) 2/4(Change from Baseline score (immediately after the 12th session -last session-))
- Psychometric self-assessment scales (PTSD) 1/4(Baseline score (1 month before TMS treatment))
- Psychometric self-assessment scales (PTSD) 4/4(Change from Baseline score at month 2 post treatment)
- Psychometric self-assessment scales (MoCA) 2/4(Change from Baseline score (immediately after the 12th session -last session-))
- Psychometric self-assessment scales (MoCA) 4/4(Change from Baseline score at month 2 post treatment)
- Psychometric self-assessment scales (King's) 2/4(Change from Baseline score (immediately after the 12th session -last session-))
- Psychometric self-assessment scales (OCI-R) 2/4(Change from Baseline score (immediately after the 12th session -last session-))
- Psychometric self-assessment scales (HADS) 2/4(Change from Baseline score (immediately after the 12th session -last session-))
- Psychometric self-assessment scales (MoCA) 3/4(Change from Baseline score at month 1 post treatment)
- Psychometric self-assessment scales (King's) 1/4(Baseline score (1 month before TMS treatment))
- Psychometric self-assessment scales (King's) 4/4(Change from Baseline score at month 2 post treatment)
- Psychometric self-assessment scales (BAI) 2/4(Change from Baseline score (immediately after the 12th session -last session-))
- Psychometric self-assessment scales (BAI) 3/4(Change from Baseline score at month 1 post treatment)
- Psychometric self-assessment scales (BAI) 4/4(Change from Baseline score at month 2 post treatment)
- Psychometric self-assessment scales (HADS) 1/4(Baseline score (1 month before TMS treatment))
- Psychometric self-assessment scales (HADS) 4/4(Change from Baseline score at month 2 post treatment)
- Psychometric self-assessment scales (HADS) 3/4(Change from Baseline score at month 1 post treatment)
研究者
Edgar Daniel Crail Melendez
MS
El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez