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

Primary Purpose

Depressive Symptoms, Epilepsy, Temporal Lobe

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
active tDCS
sham tDCS
Sponsored by
Hospital de Clinicas de Porto Alegre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depressive Symptoms

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hospital de Clínicas de Porto AlegreRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

active tDCS

sham tDCS

Arm Description

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

20-minute of daily sham stimulation above the left dorsolateral prefrontal cortex during 5 days per week for 4 weeks.

Outcomes

Primary Outcome Measures

Change in depressive symptoms, measured by Beck Depression Inventory.
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

Seizure frequency measured by crisis diary
To analyze if tDCS improves the frequency of seizures observing the crisis diary during one month before and one month after treatment.
Interictal discharge counting, using Electroencephalographic Exam
To evaluate if epilepsy is affected by tDCS, it will be counted how many interictal discharge the participant presents before and after treatment.
Brain-Derived Neurotrophic Factor (BDNF)
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).
QOLIE-31 scale
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.
Pittsburgh Sleep Quality Questionnaire
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).
Munich Chronotype Questionnaire (MCTQ)
To observe if there is change in the chronotype of these participants, through Munich Chronotype Questionnaire (MCTQ).

Full Information

First Posted
February 26, 2019
Last Updated
March 11, 2019
Sponsor
Hospital de Clinicas de Porto Alegre
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1. Study Identification

Unique Protocol Identification Number
NCT03871842
Brief Title
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

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Unknown status
Study Start Date
July 1, 2018 (Actual)
Primary Completion Date
April 1, 2019 (Anticipated)
Study Completion Date
July 1, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital de Clinicas de Porto Alegre

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depressive Symptoms, Epilepsy, Temporal Lobe

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
active tDCS
Arm Type
Active Comparator
Arm Description
20-minute of daily anodal stimulation (2mA) above the left dorsolateral prefrontal cortex during 5 days per week for 4 weeks.
Arm Title
sham tDCS
Arm Type
Sham Comparator
Arm Description
20-minute of daily sham stimulation above the left dorsolateral prefrontal cortex during 5 days per week for 4 weeks.
Intervention Type
Device
Intervention Name(s)
active tDCS
Intervention Description
Considering that the daily outpatient use of tDCS equipment is not feasible for most patients, the Pain and Neuromodulation group of the Hospital de Clínicas de Porto Alegre developed a portable tDCS device for home use that has a safe protocol, in addition of being easy to use so that the patient can use it at home without help. The safety protocol embedded in the device does not, for example, allow the appliance to be used for more than 20 minutes per day. The device can also provide the assisting staff with data such as the time the patient used the equipment, providing an accurate picture of the patient's adherence to this type of equipment. This tDCS equipment for home use has already been validated in a pilot study and will be used in this work.
Intervention Type
Device
Intervention Name(s)
sham tDCS
Intervention Description
The sham intervention will be applied exactly equal to active intervention, but the electric stimulus will last just for 30 seconds.
Primary Outcome Measure Information:
Title
Change in depressive symptoms, measured by Beck Depression Inventory.
Description
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.
Time Frame
2 months
Secondary Outcome Measure Information:
Title
Seizure frequency measured by crisis diary
Description
To analyze if tDCS improves the frequency of seizures observing the crisis diary during one month before and one month after treatment.
Time Frame
3 months
Title
Interictal discharge counting, using Electroencephalographic Exam
Description
To evaluate if epilepsy is affected by tDCS, it will be counted how many interictal discharge the participant presents before and after treatment.
Time Frame
2 months
Title
Brain-Derived Neurotrophic Factor (BDNF)
Description
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).
Time Frame
2 months
Title
QOLIE-31 scale
Description
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.
Time Frame
2 months
Title
Pittsburgh Sleep Quality Questionnaire
Description
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).
Time Frame
2 months
Title
Munich Chronotype Questionnaire (MCTQ)
Description
To observe if there is change in the chronotype of these participants, through Munich Chronotype Questionnaire (MCTQ).
Time Frame
2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients older than 18 years. Diagnosis of Temporal Lobe Epilepsy based on clinical, electrophysiological, magnetic resonance (MRI) and computed tomography (CT) imaging of the brain. Patients will be selected who are able to adequately complete the self-administered questionnaires and handle the home tDCS equipment. 13 points or more on the Beck Depression Inventory. Exclusion Criteria: Clinical history suggestive of other paroxysmal abnormalities other than temporal lobe epilepsy, such as syncope, psychogenic seizures, or transient vascular accident; Change in the antiepileptic regime in the last 30 days; History of status epilepticus on last year; Performed vagus nerve stimulation (VNS), Deep Brain Stimulation (DBS) or other neurostimulation <1 year prior to study; Active suicide plane; Contraindication for tDCS, including head injury, metal on the head or any implanted medical device, including pacemakers and cardiac defibrillators; Pregnancy.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Suelen Mota
Phone
+55 51 982808017
Email
sumota@hcpa.edu.br
First Name & Middle Initial & Last Name or Official Title & Degree
Marino Bianchin
Phone
+55 51 996376969
Email
mbianchin@hcpa.edu.br
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Suelen Mota
Organizational Affiliation
HCPA
Official's Role
Study Chair
Facility Information:
Facility Name
Hospital de Clínicas de Porto Alegre
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90040-000
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
HCPA
Phone
+55 51 3359.8304
Email
hcpa@hcpa.edu.br
First Name & Middle Initial & Last Name & Degree
Suelen Mota

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34955774
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.
Results Reference
derived

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

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