Depressive SymptomsNCT03871842

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

A study testing active tDCS in people with Depressive Symptoms and Epilepsy, Temporal Lobe, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Depressive Symptoms, Epilepsy, Temporal Lobe
What is being tested?: active tDCS
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 60 participants
Where: 1 siteBrazil
Study dates: 1 Jul 2018to 1 Jul 2019
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

Suelen Mota contact

+55 51 982808017

sumota@hcpa.edu.br

Marino Bianchin contact

+55 51 996376969

mbianchin@hcpa.edu.br

Brazil1 site, 1 recruiting

Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90040-000
HCPA, +55 51 3359.8304, hcpa@hcpa.edu.br
Suelen Mota
Recruiting

Other trials in Brazil

About this study

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

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.

Read the 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.

Conditions: Depressive Symptoms, Epilepsy, Temporal Lobe
Being tested: active tDCS, sham tDCS
Medical subject headings: Depression, Epilepsy, Temporal Lobe

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT03871842
Study group	Role	What they receive
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. Receives: 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. Receives: Device: sham tDCS

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 2 months

Secondary outcomes (6)

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.
Measured: 3 months
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.
Measured: 2 months
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).
Measured: 2 months
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.
Measured: 2 months
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).
Measured: 2 months
Munich Chronotype Questionnaire (MCTQ)
To observe if there is change in the chronotype of these participants, through Munich Chronotype Questionnaire (MCTQ).
Measured: 2 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jul 20181 Jul 2019

First posted12 Mar 2019
Study start1 Jul 2018
Primary completion1 Apr 2019 (estimated)
Study completion1 Jul 2019 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Depressive SymptomsStudies of the same condition, open and under way.
More trials run by Hospital de Clinicas de Porto AlegreThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 60 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03871842
Sponsor's protocol ID: 2018-0352
Status last verified: Jul 2018
First submitted: 26 Feb 2019
Last updated: 12 Mar 2019
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 34955774

Want to know more?

Suelen Mota

+55 51 982808017

sumota@hcpa.edu.br

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Depressive Symptoms trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT03871842
Acronym / sponsor ID: 2018-0352
Conditions: Depressive Symptoms, Epilepsy, Temporal Lobe
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 60 participants (estimated)
Lead sponsor: Hospital de Clinicas de Porto AlegreUniversity, hospital or other
Study start: 1 Jul 2018 (actual)
Primary completion: 1 Apr 2019 (estimated)
Study completion: 1 Jul 2019 (estimated)
First posted: 12 Mar 2019 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
active tDCS	Active comparator	Device: active tDCS20-minute of daily anodal stimulation (2mA) above the left dorsolateral prefrontal cortex during 5 days per week for 4 weeks.
sham tDCS	Sham comparator	Device: sham tDCS20-minute of daily sham stimulation above the left dorsolateral prefrontal cortex during 5 days per week for 4 weeks.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (7 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
active tDCSConsidering 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.	Device	active tDCS
sham tDCSThe sham intervention will be applied exactly equal to active intervention, but the electric stimulus will last just for 30 seconds.	Device	sham tDCS

Primary outcome

Change in depressive symptoms, measured by Beck Depression Inventory.
Time frame: 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.

6 secondary outcomes

Seizure frequency measured by crisis diary
Time frame: 3 months
Interictal discharge counting, using Electroencephalographic Exam
Time frame: 2 months
Brain-Derived Neurotrophic Factor (BDNF)
Time frame: 2 months
QOLIE-31 scale
Time frame: 2 months
Pittsburgh Sleep Quality Questionnaire
Time frame: 2 months
Munich Chronotype Questionnaire (MCTQ)
Time frame: 2 months

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2019.
Derived from this study: PubMed 34955774Mota 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Suelen Mota contact

+55 51 982808017

sumota@hcpa.edu.br

Marino Bianchin contact

+55 51 996376969

mbianchin@hcpa.edu.br

Suelen Mota study chair

HCPA

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing active tDCS in people with Depressive Symptoms and Epilepsy, Temporal Lobe, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 12 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Suelen Mota (+55 51 982808017, sumota@hcpa.edu.br), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in depressive symptoms, measured by Beck Depression Inventory. (time frame: 2 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03871842, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2019.