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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-01

Study Completion Date

2019-07-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Investigating tDCS as a Treatment for Unipolar and Bipolar Depression

NCT01562184

Unipolar Depression Bipolar Depression

COMPLETED PHASE2/PHASE3

Effects of tDCS on Cognitive Control and Emotion Regulation in Depressed Patients

NCT03039387

Anodal Stimulation tDCS Major Depression Cognitive Control +1 more

UNKNOWN NA

TDCS Interventions for Subthreshold Depressive Symptoms in Young Individuals.

NCT06294184

Subthreshold Depression Young People Transcranial Direct Current Stimulation

RECRUITING NA

Transcranial Direct Current Stimulation (tDCS) in Children and Adolescents With Epilepsy and Depression

NCT03368469

Depressive Disorder Generalized Epilepsy

WITHDRAWN NA

Effects of tDCS-enhanced Cognitive Control Training on Depression

NCT03518749

Depression Unipolar

UNKNOWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Depressive Symptoms Epilepsy, Temporal Lobe

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

active tDCS

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

Group Type ACTIVE_COMPARATOR

active tDCS

Intervention Type DEVICE

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.

sham tDCS

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

Group Type SHAM_COMPARATOR

sham tDCS

Intervention Type DEVICE

The sham intervention will be applied exactly equal to active intervention, but the electric stimulus will last just for 30 seconds.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

active tDCS

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

sham tDCS

The sham intervention will be applied exactly equal to active intervention, but the electric stimulus will last just for 30 seconds.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No