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

NCT03871842 | Unknown

• 1 other identifier: 2018-0352
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Depressive Symptoms; Epilepsy, Temporal Lobe

Outcome Measures

Primary Outcomes (1)

• 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.

  2 months

Secondary Outcomes (6)

• Seizure frequency measured by crisis diary

  3 months

• Interictal discharge counting, using Electroencephalographic Exam

  2 months

• Brain-Derived Neurotrophic Factor (BDNF)

  2 months

• QOLIE-31 scale

  2 months

• Pittsburgh Sleep Quality Questionnaire

  2 months

Study Arms (2)

active tDCS

ACTIVE COMPARATOR

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

Device: active tDCS

sham tDCS

SHAM COMPARATOR

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

Device: sham tDCS

Interventions

active tDCS 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.

active tDCS

sham tDCS DEVICE

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

sham tDCS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• points or more on the Beck Depression Inventory.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital de Clinicas de Porto Alegre: lead

Study Sites (1)

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90040-000, Brazil

RECRUITING

Related Publications (1)

• 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.

  PMID: 34955774 DERIVED

MeSH Terms

Conditions

Depression; Epilepsy, Temporal Lobe

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Epilepsies, Partial; Epilepsy; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Epileptic Syndromes

Study Officials

• Suelen Mota

  HCPA

  STUDY CHAIR

Central Study Contacts

Suelen Mota

CONTACT

+55 51 982808017; sumota@hcpa.edu.br

Marino Bianchin

CONTACT

+55 51 996376969; mbianchin@hcpa.edu.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2019
• First Posted: March 12, 2019
• Study Start: July 1, 2018
• Primary Completion: April 1, 2019
• Study Completion: July 1, 2019
• Last Updated: March 12, 2019

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)