EEG Prediction and Clinical Efficacy of tDCS in Major Depression

Official title

Clinical Efficacy of tDCS in Major Depression: A Controlled Clinical Trial and Analysis of Electrophysiological Biomarker Predictors

Overview

The purpose of this randomized controlled trial is to investigate the non-inferiority, and possible superiority, of a high-dose home-based tDCS protocol compared with a conventional home-based protocol, and to assess its cost-effectiveness, in patients with major depression. As a secondary aim, we aim to assess the predictive value of baseline EEG for clinical response to high-dose home-based tDCS treatment in patients with major depression.

Interventions

• Device High-dose home-tDCS
  Transcranial direct current stimulation (tDCS) is a non-invasive brain stimulation technique in which a weak direct current (2 mA) is applied to the scalp via electrodes. The anode will be applied to F3 (left dorsolateral prefrontal region) and the cathode to F8 (right supraorbital region). The application of tDCS will be carried out at home in this group. Each session will consist of 20 minutes of stimulation. Dose: 3 weeks, daily. (1) 1st week - 3 times per day; (2) 2nd Week - 2 times per day;
• Device Conventional home-tDCS
  Transcranial direct current stimulation (tDCS) is a non-invasive brain stimulation technique in which a weak direct current (2 mA) is applied to the scalp via electrodes. The anode will be applied to F3 (left dorsolateral prefrontal region) and the cathode to F4 (left dorsolateral prefrontal region), described by Woodham et al., 2024. The application of tDCS will be carried out at home in this group. Each session will consist of 30 minutes of stimulation. Dose: (1) Week 1 to 3: 1ss/day for 5 day

Primary outcome measures

• HDRS-17 [Time frame: Baseline and end of treatment (week 3 for experimental; week 10 for active comparator).]

Secondary outcome measures (12)

• MDRS [Time frame: Baseline; end of treatment (3 week experimental; 10 week active comparator).]
• C-SSRS [Time frame: Baseline; end of treatment (3 week experimental; 10 week active comparator)]
• HAM-A [Time frame: Baseline; end of treatment (3 week experimental; 10 week active comparator)]
• YMRS [Time frame: Baseline; end of treatment (3 week experimental; 10 week active comparator)]
• RAVLT [Time frame: Baseline; end of treatment (3 week experimental; 10 week active comparator)]
• SDMT [Time frame: Baseline; end of treatment (3 week experimental; 10 week active comparator).]
• Bristol stool scale [Time frame: Baseline; end of treatment (3 week experimental; 10 week active comparator).]
• Mediterranean Diet Questionnaire [Time frame: Baseline]
• Meal frequency [Time frame: Baseline]
• EQ-5D [Time frame: Baseline; end of treatment (3 week experimental; 10 week active comparator).]
• PGI-C [Time frame: End of treatment (3 week experimental; 10 week active comparator)]
• Resting state EEG [Time frame: Baseline]

Eligibility criteria

Inclusion criteria

• Patients aged 18 years or over.
• Patients diagnosed with Major Depressive Disorder with a current depressive episode, based on the criteria of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) (American Psychiatric Association, 2013).
• Score on the Hamilton Depression Rating Scale (HDRS-17) ≥16 (Hamilton et al., 1960).
• Patients on a stable prescription of antidepressants/pharmacological medication and who agree to continue this throughout the study; and/or, if undergoing psychotherapy, who have maintained this treatment consistently for at least 6 weeks.
• Demonstrate the ability to apply home-based tDCS appropriately, either independently or with the help of a carer.
• Have access to an electronic device with a camera to enable monitoring of the intervention, as well as to contact the participant.
• Have the ability and willingness to commit to the study team to complete all phases of the study.
• Volunteer to participate and sign the specific informed consent form for this study.

Exclusion criteria

• Patients with a current manic episode as determined by the Young Mania Rating Scale (YMRS), or a psychotic episode as defined by the MINI scale.
• Patients who answer 'yes' to questions 4, 5 or 6 of the Columbia Suicide Severity Rating Scale (C-SSRS), a risk assessment and identification tool.
• Patients with treatment-resistant depression, defined as an inadequate clinical response to two or more courses of antidepressant treatment at appropriate doses and duration.
• Any previous hospitalisation for suicidal behaviour.
• Presenting with current chronic or severe insomnia (< 4 hours' sleep per night) or sleep apnoea.
• Presence of any structural lesion (e.g., any structural neurological condition or more subcortical lesions than would be expected for their age, or having suffered a stroke affecting the stimulated area or connected areas) or any other clinically significant abnormality that may affect safety, participation in the study, or confound the interpretation of study results, as determined by the investigator.
• History or presence of any other condition or comorbidity associated with TDM: cardiac or neurological conditions, cognitive impairment.
• History of or current diagnosis of any other mental disorder: obsessive-compulsive disorder, bipolar disorder (type 1 or 2), anxiety disorder, agoraphobia, eating disorders, personality disorders.
• Any exclusion criteria other than those established by clinical guidelines on non-invasive brain stimulation (Woods et al., 2016):
• Metal implants or head injuries, any electronic devices such as cochlear implants or cardiac pacemakers
• Brain stimulation within the last 6 months.
• Clinical or family history of epilepsy or seizure episodes.
• Presence of dermatological problems (allergic skin reaction at the electrode site, psoriasis, etc.)
• History of drug or alcohol abuse during the study or in the 3 months prior (with the exception of nicotine).
• Pending trial or litigation during the course of the trial.
• Pregnancy.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

Spain · 1 center

• Hospital Universiatrio Doctor Peset — Valencia

Identifiers

NCT: NCT07611773 · ION001_EEG_TDCS_TDM

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗