Clinical trial NCT03871842: Effects of tDCS on Depressive Symptoms of Participants With Temporal Lobe Epilepsy
Official title: Study on the Safety and Effects of Transcranial Direct Current Stimulation (tDCS) in the Treatment of Depressive Symptoms in Participants With Temporal Lobe Epilepsy: A Randomized, Double-blind, Sham-controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Depressive Symptoms
Epilepsy, Temporal Lobe
Lead sponsor: Hospital de Clinicas de Porto Alegre
Sponsor class: OTHER
First posted: 2019-03-12
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This project was developed to analyze the clinical, biochemical and functional impact of tDCS on depressive symptoms in participants with temporal lobe epilepsy, intending to collaborate directly in the development of new therapeutic strategies for participants with epilepsy and associated mood disorders. Another objective of this work is to add knowledge about biosafety, possible behavioral and electrophysiological effects of tDCS in participants with temporal lobe epilepsy. Depending on the findings, the study as proposed may provide immediate results for the care of participants with epilepsy.

Detailed description: Transcranial direct current stimulation (tDCS) has emerged as an alternative tool in the treatment of participants with mood disorders and may also benefit the treatment of participants with epilepsy. However, this therapeutic tool has been little explored in the treatment of mood disorders in participants with epilepsy. Considering these aspects, the main objective of this project is to study the safety and possible therapeutic effects of tDCS in depressive symptoms of participants with temporal lobe epilepsy. As secondary objectives, stands out the evaluation of the effects of this stimulation on the frequency of epileptic seizures and on electrophysiological and biochemical parameters in these participants. To do this, after performing semi-structured interviews to evaluate depressive symptoms, quality of life and sleep, participants with Temporal Lobe Epilepsy will be randomized into two groups: 1) intervention with tDCS in participants with Temporal Lobe Epilepsy and depressive symptoms (T) and 2) sham intervention in participants with Temporal Lobe Epilepsy and depressive symptoms (S). After studying and characterizing the behavioral, biochemical and electroencephalic patterns (EEG), the T group will be submitted to tDCS. The control group will perform the same assessments and the same preparatory procedures, but will not receive the electrical stimulus. Finally, in addition to the analysis of the electroencephalographic patterns of the two groups at the end of each session, the analysis of the brain-derived Neurotrophic Factor Neurotrophic Factor (BDNF) will also be performed, as well as a new clinical evaluation regarding the frequency of seizures and patterns of these participants through the same semi-structured interviews conducted initially.

Eligibility criteria: Inclusion Criteria:

1. Patients older than 18 years.
2. Diagnosis of Temporal Lobe Epilepsy based on clinical, electrophysiological, magnetic resonance (MRI) and computed tomography (CT) imaging of the brain.
3. Patients will be selected who are able to adequately complete the self-administered questionnaires and handle the home tDCS equipment.
4. 13 points or more on the Beck Depression Inventory.

Exclusion Criteria:

1. Clinical history suggestive of other paroxysmal abnormalities other than temporal lobe epilepsy, such as syncope, psychogenic seizures, or transient vascular accident;
2. Change in the antiepileptic regime in the last 30 days;
3. History of status epilepticus on last year;
4. Performed vagus nerve stimulation (VNS), Deep Brain Stimulation (DBS) or other neurostimulation \<1 year prior to study;
5. Active suicide plane;
6. Contraindication for tDCS, including head injury, metal on the head or any implanted medical device, including pacemakers and cardiac defibrillators;
7. Pregnancy.

Primary outcomes:
measure: Change in depressive symptoms, measured by Beck Depression Inventory.
timeFrame: 2 months
Secondary outcomes:
measure: Seizure frequency measured by crisis diary
timeFrame: 3 months
measure: Interictal discharge counting, using Electroencephalographic Exam
timeFrame: 2 months
measure: Brain-Derived Neurotrophic Factor (BDNF)
timeFrame: 2 months
measure: QOLIE-31 scale
timeFrame: 2 months
measure: Pittsburgh Sleep Quality Questionnaire
timeFrame: 2 months
measure: Munich Chronotype Questionnaire (MCTQ)
timeFrame: 2 months
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Hospital de Clínicas de Porto Alegre
state: Rio Grande Do Sul
Study officials:
affiliation: HCPA
name: Suelen Mota
role: STUDY_CHAIR
References:
citation: Mota SM, Amaral de Castro L, Riedel PG, Torres CM, Bragatti JA, Brondani R, Secchi TL, Sanches PRS, Caumo W, Bianchin MM. Home-Based Transcranial Direct Current Stimulation for the Treatment of Symptoms of Depression and Anxiety in Temporal Lobe Epilepsy: A Randomized, Double-Blind, Sham-Controlled Clinical Trial. Front Integr Neurosci. 2021 Dec 8;15:753995. doi: 10.3389/fnint.2021.753995. eCollection 2021.