Effects of tDCS on Depressive Symptoms of Participants With Temporal Lobe Epilepsy

Not Applicable

• Conditions: Epilepsy, Temporal Lobe; Depressive Symptoms
• Interventions: Device: active tDCS; Device: sham tDCS

• Registration Number: NCT03871842
• Lead Sponsor: Hospital de Clinicas de Porto Alegre

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.

Study Timeline

• Status Verified: 2018-07
• Study Start: 2018-07-01
• Study First Submitted: 2019-02-26
• Study First Submitted QC: 2019-03-11
• Last Update Submitted: 2019-03-11
• Study First Posted: 2019-03-12
• Last Update Posted: 2019-03-12
• Primary Completion: 2019-04-01
• Study Completion: 2019-07-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
active tDCS	active tDCS	20-minute of daily anodal stimulation (2mA) above the left dorsolateral prefrontal cortex during 5 days per week for 4 weeks.
sham tDCS	sham tDCS	20-minute of daily sham stimulation above the left dorsolateral prefrontal cortex during 5 days per week for 4 weeks.

Primary Outcome Measures

Name	Time	Method
Change in depressive symptoms, measured by Beck Depression Inventory.	2 months	The objective of this work is to evaluate the antidepressant effect of transcranial direct current stimulation in participants with temporal lobe epilepsy, measuring the depressive symptoms by Beck Depression Inventory before and after treatment, which score ranges from 0 to 21. High values represent more severe depressive symptoms.

Secondary Outcome Measures

Name	Time	Method
Seizure frequency measured by crisis diary	3 months	To analyze if tDCS improves the frequency of seizures observing the crisis diary during one month before and one month after treatment.
QOLIE-31 scale	2 months	To observe if there is an improvement in the quality of life of these participants, through the increase of points in the Quality of Life in Epilepsy scale (QOLIE-31), which score ranges from 0-100. High values represent better quality of life.
Brain-Derived Neurotrophic Factor (BDNF)	2 months	To explore possible changes of BDNF in the groups at three times (before treatment, after 20 days of treatment and after the follow-up period), and possible correlation with the clinical findings. BDNF will be measured in Picograms Per Millilitre (pg/mL).
Pittsburgh Sleep Quality Questionnaire	2 months	To observe if there is improvement in sleep patterns of the participants, through Pittsburgh Sleep Quality Questionnaire, which score ranges from 0 to 21 (high scores represent better quality of sleep).
Interictal discharge counting, using Electroencephalographic Exam	2 months	To evaluate if epilepsy is affected by tDCS, it will be counted how many interictal discharge the participant presents before and after treatment.
Munich Chronotype Questionnaire (MCTQ)	2 months	To observe if there is change in the chronotype of these participants, through Munich Chronotype Questionnaire (MCTQ).

Trial Locations

Locations (1)

Hospital de Clínicas de Porto Alegre; 🇧🇷 Porto Alegre, Rio Grande Do Sul, Brazil