Home-based Transcranial Direct Current Stimulation for Treatment Resistant Depression
1 other identifier
interventional
106
1 country
1
Brief Summary
The aim of this phase II, randomized, double-blind clinical trial is to evaluate the effect of home-based transcranial direct current stimulation (tDCS) in patients with treatment-resistant depression. Major depressive disorder is defined by depressed mood and/or loss of interest in activities, during most of the day, nearly every day, for at least two weeks. It is usually accompanied by other symptoms, such as fatigue, sleep disturbances, thoughts of guilt, suicidal ideation, appetite alterations, difficulty to focus and physical agitation or retardation. It is estimated that its worldwide prevalence is 5%, affecting 280-300 million people. A third of patients with depression will develop treatment resistant depression, where symptoms fail to remit after at least two trials of antidepressants. Beyond psychotropics, another treatment option is neuromodulation, where excitatory or inhibitory signals are delivered to the brain, in order to modulate cortical excitability. The tDCS is a non-invasive brain stimulation method that applies a low intensity direct current (1-2mA) directed to the scalp via the cathode and anode electrodes. The current reaches the cortex, facilitating hyperpolarization or depolarization of the axonal membrane potential. Evidence has shown that this method is presented as a technique able to alter cortical and subcortical neural networks. This technique has been used to treat psychiatric disorders such as depression, bipolar affective disorder, panic, hallucinations, obsessive compulsive disorder, schizophrenia, withdrawal, rehabilitation after stroke and pain syndromes such as neuropathic pain, migraine and fibromyalgia. It has a low cost and less side effects than psychotropic medications. In order to be effective, daily repeated sessions of 20-40 minutes are necessary. When applied in a hospital setting, this frequency of sessions can limit its appliance, especially for depressed patients, whose symptoms include fatigue and loss of interest in activities. Furthermore, transportation costs, frequent absences from work and other activities and overload of the healthcare system would also limit its use. Home based devices are portable and easily operated. Thus, it is possible for patients to administer themselves the treatment, in their own home, everyday. Therefore, the aim of this study is to evaluate the effect of home-based tDCS in treatment resistant depression patients in long-term treatment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jul 2022
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2022
CompletedFirst Submitted
Initial submission to the registry
October 13, 2022
CompletedFirst Posted
Study publicly available on registry
October 26, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 20, 2025
CompletedApril 30, 2024
April 1, 2024
3 years
October 13, 2022
April 29, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in scores obtained in the Hamilton Depression Rating Scale
Change in depressive symptoms, measured by the 17-item version of the Hamilton Depression Rating Scale, before, during and after application of home-based tDCS. The score values ranges from 0 to 49, and higher scores represent worse outcomes.
Assessed in visit 2 (baseline pre-sham stimulation, week 0), visit 3 (baseline post-sham stimulation, week 2), visit 4 (middle of the trial, week 5), visit 5 (upon trial completion, week 8) and visit 6 (3 months after trial completion)
Secondary Outcomes (20)
Change in scores in the Patient Health Questionnaire - 9
Assessed in visit 2 (baseline pre-sham stimulation, week 0), visit 3 (baseline post-sham stimulation, week 2), visit 4 (middle of the trial, week 5), visit 5 (upon trial completion, week 8) and visit 6 (3 months after trial completion)
Change in Clinical Global Impression of Severity scores
Assessed in visit 2 (baseline pre-sham stimulation, week 0), visit 4 (middle of the trial, week 5), visit 5 (upon trial completion, week 8) and visit 6 (3 months after trial completion)
Change in the Eurohis-Quality of Life Index
Assessed in visit 2 (baseline pre-sham stimulation, week 0), visit 4 (middle of the trial, week 5) and visit 5 (upon trial completion, week 8)
Change in the 12-item World Health Organization Disability Assessment Schedule II
Assessed in visit 2 (baseline pre-sham stimulation, week 0), visit 4 (middle of the trial, week 5) and visit 5 (upon trial completion, week 8)
Change in the Screen for Cognitive Impairment in Psychiatry
Assessed in visit 2 (baseline pre-sham stimulation, week 0) and visit 5 (upon trial completion, week 8)
- +15 more secondary outcomes
Study Arms (2)
Active tDCS
EXPERIMENTALParticipants will receive 30 daily sessions of tDCS. Each session lasts 20 minutes, and delivers a current of 2mA.
Sham tDCS
SHAM COMPARATORParticipants will receive 30 daily sessions of sham tDCS. Each session lasts 20 minutes, and the sham programming delivers 3 ramps of 30 seconds of active current, the first in the first minute of the session, the second after 10 minutes and the third at the last minute of the session.
Interventions
Session description: An electric current of 2mA will be delivered through 35 square centimeters electrodes covered by sponges dampened with saline to reduce impedance. The anode will be placed over the left dorsolateral prefrontal cortex and the cathode will be placed over the right dorsolateral prefrontal cortex. The electrodes will be fixed in a neoprene cap to ascertain their positioning. Session duration: 20 minutes Frequency of sessions: Daily sessions, from monday to friday, skipping weekends, during 6 weeks. Number of sessions: 30 sessions The first randomized session will be delivered in the third assessment visit, two weeks after the run-in sham session.
Session description: Three ramps of 30 seconds of current will be delivered through 35 square centimeters electrodes covered by sponges dampened with saline to reduce impedance. One electrode will be placed over the left dorsolateral prefrontal cortex and the other electrode will be placed over the right dorsolateral prefrontal cortex. The electrodes will be fixed in a neoprene cap to ascertain their positioning. Session duration: 20 minutes Frequency of sessions: Daily sessions, from monday to friday, skipping weekends, during 6 weeks. Number of sessions: 30 sessions The first randomized session will be delivered in the third assessment visit, two weeks after the run-in sham session.
In the second assessment visit, one run-in 20-minute session of sham stimulation, consisting of three ramps of 30 seconds of current, will be delivered through 35 square centimeters electrodes covered by sponges dampened with saline to reduce impedance. One electrode will be placed over the left dorsolateral prefrontal cortex and the other electrode will be placed over the right dorsolateral prefrontal cortex. The electrodes will be fixed in a neoprene cap to ascertain their positioning.
Watching a video, produced by the research team, containing a brief explanation of what depression is and how it's treated.
Watching a video, produced by the research team, containing instructions on how to operate de tDCS devices.
Eligibility Criteria
You may qualify if:
- Outpatients
- Current diagnosis of Major Depressive Episode according to Diagnostic and Statistical Manual of Mental Disorders (5th edition) criteria
- Presence of depressive symptoms that did not improve after at least two trials of first line antidepressants, for at least four weeks each, in optimized doses
- Patients living in Porto Alegre or its metropolitan region
- No changes in prescription in the last four weeks upon entering the trial
You may not qualify if:
- Psychotic symptoms
- Acute risk, or indication of hospitalization
- Diagnosis of current Substance Use Disorder (alcohol, marijuana, cocaine, sedatives/hypnotics, stimulants, inhalants and others) according to DSM-V criteria
- Presence of metallic implants or medical devices implanted in the brain
- Pacemakers and cochlear implants
- Neurological diseases: epilepsy, malformations
- History of head trauma or neurosurgery
- Pregnancy
- Cognitive impairment severe enough to prevent the operation of the tDCS device without professional assistance
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital de Clinicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035903, Brazil
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Marcelo Pio de Almeida Fleck, MD
Hospital de ClĂnicas de Porto Alegre
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 13, 2022
First Posted
October 26, 2022
Study Start
July 1, 2022
Primary Completion
June 30, 2025
Study Completion
December 20, 2025
Last Updated
April 30, 2024
Record last verified: 2024-04
Data Sharing
- IPD Sharing
- Will not share