Home-based tDCS in Major Depressive Disorder

NCT04799405 | Completed Results FDA Device

• 1 other identifier: Pro00044198
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators propose a study of telehealth supervised, caregiver-delivered, home-based transcranial direct current stimulation (tDCS) for antidepressant treatment of patients with an acute depressive episode.

Conditions

Major Depressive Disorder

Keywords

non-invasive brain stimulation (NIBS); transcranial direct current stimulation (tDCS)

Outcome Measures

Primary Outcomes (2)

• Montgomery-Asberg Depression Rating Scale (MADRS)

  The MADRS is a 10-item clinical rating scale to measure the severity of depressive symptoms based on a clinical interview with a participant/patient. Higher MADRS score indicates more severe depression, and each item yields a score of 0 to 6. The overall score ranges from 0 to 60, and includes questions related to: apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts. Cut off points are: 0 to 6 - normal, symptom absent, 7 to 19 - mild depression, 20 to 34 - moderate depression, \>34 - severe depression. Clinical remission is considered as a MADRS score ≤ 10. The primary outcome will be total MADRS score from baseline to one-month follow-up (pre and post-intervention; 12 weeks).

  12 weeks

• Number of Treatment-Emergent Adverse Events [Safety and Tolerability] and Missed Sessions

  Feasibility and tolerability/safety will be evaluated using home-based data as recorded in the Neuroelectrics portal: number of missed sessions and number of adverse events reported on adverse event questionnaire

  12 weeks

Secondary Outcomes (7)

• The Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF)

  12 weeks

• The Quick Inventory of Depressive Symptomatology (16-Item) (Self-Report)(QIDS-SR16)

  12 weeks

• Beck Depression Inventory (BDI)

  12 weeks

• Hamilton Depression Rating Scale

  12 weeks

• Montreal Cognitive Assessment (MoCA)

  12 weeks

Study Arms (1)

tDCS MDD

EXPERIMENTAL

A group of 5 participants with major depressive disorder (MDD). tDCS, as a relatively simple and portable technology, is particularly well suited for remotely-supervised, home-based treatment, which would facilitate longer periods of treatment as well as offer a suitable therapeutic option at the present time as the investigators aim to deal with the COVID-19 pandemic.

Device: tDCS

Interventions

tDCS DEVICE

Daily sessions (28 daily sessions): The device will be used to apply 30 minutes of tDCS to the participant with MDD's scalp in each of 28 daily sessions. Thereafter, participants with MDD will undergo a taper phase of an additional 9 sessions of tDCS applied in progressively decreasing frequency until day #60 of the study as follows: 1. First taper phase: three 30 minutes tDCS sessions applied every other day; 2. Second taper phase: three 30 minutes tDCS sessions applied one every third day; 3. Third and final taper phase: three final 30 minutes tDCS sessions applied one every fourth day.

Also known as: Transcranial direct current stimulation (tDCS)

tDCS MDD

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Individuals with MDD
• Participants will be men and women who:
• Are aged 50 or older
• Able to read, write, and communicate in English
• Have a caregiver who is willing and able to provide the home tDCS sessions.
• Participants must be under the care of a treating psychiatrist who approves of the study participation and believes that TMS or ECT is indicated for his/her patient but that
• it would not endanger the patient to participate in the present study rather than pursue such alternative, or
• Participants with MDD must fit into one of the following 3 groups (medication-resistant MDD defined as 1) participant's condition has not responded to prescribed antidepressant medication; 2) participant is medication intolerant, or 3) some other underlying reason):
• Patients with medication-resistant Major depressive disorder (MDD) who have undergone repetitive transcranial magnetic stimulation (rTMS) or electroconvulsive therapy (ECT) and responded to it but whose benefit has lapsed and they need repeat rTMS or ECT course that they cannot access;
• Patients with medication-resistant MDD who are undergoing rTMS or ECT and responding, but cannot continue to get the rTMS or ECT course due to COVID-19 pandemic-related regulations or other access concerns
• Patients with medication-resistant MDD who are referred to rTMS or ECT and are found well qualified but cannot access rTMS or ECT due to COVID-19 pandemic-related regulations or other access concerns.
• Further, participants must:
• Meet criteria for a diagnosis of MDD according to the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-TR) (American Psychiatric Association, 2000), as determined via an tele-health interview with a study psychiatrist, and confirmed with the Mini International Neuropsychiatric Interview (MINI; Version 5.0.0) (Sheehan et al., 1998) and the prospective participant's primary psychiatrist.
• Currently experiencing a major depressive episode of at least four weeks' duration as part of a unipolar or bipolar depression. Score will need to be at least 20 on the MADRS.
• Further, participants must have a willing and eligible caregiver-administrators who is:

You may not qualify if:

• Any DSM-psychotic disorder
• Drug or alcohol abuse or dependence in the preceding three months;
• Concurrent benzodiazepine medication;
• High suicide risk (Utilizing the Beck Depression Inventory and the Hamilton Depression Scale, suicide risk will be assessed at baseline by the study psychiatrist) ;
• History of clinically defined neurological disorder or insult; Metal in the cranium or skull defects;
• Skin lesions on the scalp at the proposed electrode sites;
• Pregnancy.
• Medical devices (i.e. cardiac pacemaker, deep brain stimulator, medication infusion pump, cochlear implant, vagus nerve stimulator).
• Previous skull surgery with resultant skull defects
• Inability to understand study procedures following review of the Informed Consent form.
• Understanding will be assessed by asking the participant with MDD to answer the following three questions:
• What is the purpose of this study?
• What are the risks of study involvement?
• If you decide to participate, are you allowed to withdraw from the study at any time? Answers will be recorded by study personnel on the "Assessment of Protocol Understanding" form. Insufficient understanding will be defined by one or more incorrect answers, as determined at the discretion of the investigator.
• Poor eyesight,

Sponsors & Collaborators

• Hebrew SeniorLife: lead

Study Sites (1)

Hinda and Arthur Marcus Institute for Aging Research

Boston, Massachusetts, 02131, United States

Location

Related Publications (4)

• Alonzo A, Fong J, Ball N, Martin D, Chand N, Loo C. Pilot trial of home-administered transcranial direct current stimulation for the treatment of depression. J Affect Disord. 2019 Jun 1;252:475-483. doi: 10.1016/j.jad.2019.04.041. Epub 2019 Apr 10.

  PMID: 31005790 RESULT

• Antal A, Alekseichuk I, Bikson M, Brockmoller J, Brunoni AR, Chen R, Cohen LG, Dowthwaite G, Ellrich J, Floel A, Fregni F, George MS, Hamilton R, Haueisen J, Herrmann CS, Hummel FC, Lefaucheur JP, Liebetanz D, Loo CK, McCaig CD, Miniussi C, Miranda PC, Moliadze V, Nitsche MA, Nowak R, Padberg F, Pascual-Leone A, Poppendieck W, Priori A, Rossi S, Rossini PM, Rothwell J, Rueger MA, Ruffini G, Schellhorn K, Siebner HR, Ugawa Y, Wexler A, Ziemann U, Hallett M, Paulus W. Low intensity transcranial electric stimulation: Safety, ethical, legal regulatory and application guidelines. Clin Neurophysiol. 2017 Sep;128(9):1774-1809. doi: 10.1016/j.clinph.2017.06.001. Epub 2017 Jun 19.

  PMID: 28709880 RESULT

• Brunoni AR, Moffa AH, Fregni F, Palm U, Padberg F, Blumberger DM, Daskalakis ZJ, Bennabi D, Haffen E, Alonzo A, Loo CK. Transcranial direct current stimulation for acute major depressive episodes: meta-analysis of individual patient data. Br J Psychiatry. 2016 Jun;208(6):522-31. doi: 10.1192/bjp.bp.115.164715. Epub 2016 Apr 7.

  PMID: 27056623 RESULT

• Cappon D, den Boer T, Jordan C, Yu W, Lo A, LaGanke N, Biagi MC, Skorupinski P, Ruffini G, Morales O, Metzger E, Manor B, Pascual-Leone A. Safety and Feasibility of Tele-Supervised Home-Based Transcranial Direct Current Stimulation for Major Depressive Disorder. Front Aging Neurosci. 2022 Feb 2;13:765370. doi: 10.3389/fnagi.2021.765370. eCollection 2021.

  PMID: 35185515 DERIVED

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Results Point of Contact

• Title: Dr. Pascual-Leone
• Organization: Hebrew SeniorLife

apleone@hsl.harvard.edu

6179715372

Study Officials

• Alvaro Pascual-Leone, Dr.

  Hinda and Arthur Marcus Institute for Aging Research

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Scientist-Professor of Neurology

Study Record Dates

• First Submitted: March 10, 2021
• First Posted: March 16, 2021
• Study Start: September 24, 2020
• Primary Completion: July 2, 2021
• Study Completion: July 2, 2021
• Last Updated: March 24, 2022
• Results First Posted: March 24, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)