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Major Depressive DisorderNCT05205915

Home-based Transcranial Direct Current Stimulation (tDCS) for Major Depressive Disorders (MDD)

A study testing tDCS intervention applied by Starstim device in people with Major Depressive Disorder, run by Neuroelectrics Corporation at 4 sites in United States.

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 The sponsor has not verified this record for over two years, so it may be out of date.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

This is an open label pilot feasibility telemedicine study. This pilot will involve a total of 37 at-home stimulation sessions (30-minutes each) of multichannel excitatory tDCS targeting the left dorsolateral prefrontal cortex (DLPFC) administered over 8 weeks, with a follow-up period of 4 weeks following the final… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Major Depressive Disorder
What is being tested?
tDCS intervention applied by Starstim device
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
34 participants
Where
4 sitesUnited States
Study dates
2 Feb 2022to Dec 2022
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

  • Major Depressive Disorder
  • Age >=18
  • Currently experiencing a major depressive episode of at least four weeks' duration
  • MADRS score at least 20 at trial entry.
  • Taking at least one approved antidepressant medication (except bupropion).
  • Has a healthcare provider, and a companion who can help administer study treatments; and be able to connect frequently with study staff
  • Access to wireless internet (wifi) connection

Who cannot join

  • Any psychotic disorder.
  • Concurrent benzodiazepine medication.
  • High suicide risk
  • History of significant neurological disorder.
  • Skin lesions on the scalp at the proposed electrode sites.
  • Pregnancy.
Show all 11Show fewer
  • Any antidepressant medications will be permitted (except bupropion) provided the medication dose has been unchanged for 4 weeks prior to trial entry.
  • Any cranial metal implants (excluding ≤1 mm thick epicranial titanium skull plates and dental fillings) or
  • Medical devices (i.e. cardiac pacemaker, deep brain stimulator, medication infusion pump, cochlear implant, vagus nerve stimulator);
  • Previous surgeries opening the skull leaving skull defects capable of allowing the insertion of a cylinder with a radius greater or equal to 5 mm.
  • Substance use disorder (including alcohol) within the past year.

Trial locations and contacts

4 sites in 1 country.

United States4 sites

  • Healthcare Innovations Institute, LLC

    Coral Springs, Florida, 33067

  • Conrad Clinical Research

    Edmond, Oklahoma, 73013

  • Oceane7 Medical & Research Center, Inc.

    Miami, Florida, 33144

  • Renew Health Clinical Research, LLC

    Snellville, Georgia, 30078

Other trials in United States

About this study

This is an open label pilot feasibility telemedicine study. This pilot will involve a total of 37 at-home stimulation sessions (30-minutes each) of multichannel excitatory tDCS targeting the left dorsolateral prefrontal cortex (DLPFC) administered over 8 weeks, with a follow-up period of 4 weeks following the final stimulation session.

Read the detailed description

This is an open label pilot feasibility telemedicine study. This pilot will involve a total of 37 at-home stimulation sessions (30-minutes each) of multichannel excitatory tDCS targeting the left dorsolateral prefrontal cortex (DLPFC) administered over 8 weeks, with a follow-up period of 4 weeks following the final stimulation session.

The main objective of the study is to assess the feasibility and safety of home-based tDCS for patients with MDD.

The treatment course will consist of an acute phase of 28 tDCS sessions, conducted daily (7 days per week) over 4 weeks.

Thereafter, participants 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. Three tDCS sessions applied once every other day.
  2. Three tDCS sessions applied once every third day.
  3. Three tDCS sessions applied once every fourth day.
Being tested
tDCS intervention applied by Starstim device
Medical subject headings
Depressive Disorder, Major

What participants receive

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

  • tDCS intervention applied by Starstim deviceDevice

    Also called Starstim

    Stimulation will be applied using the Starstim device, with current delivered via four Starstim Pi electrodes (circular electrodes with a contact of area of 3.14 cm2) embedded in the headpiece. All study subjects will use the same fixed montage (electrode locations and currents). The montage has been designed to optimize anodal stimulation in the desired target area while avoiding stimulation off target.

Study groups in NCT05205915
Study groupRoleWhat they receive
Single armExperimentalAll patients will receive active treatment which consists of stimulation (tDCS) applied using the Starstim device, with current delivered via four Starstim Pi electrodes (circular electrodes with a contact of area of 3.14 cm2) embedded in the headpiece. All study subjects will use the same fixed montage (electrode locations and currents).
Receives: Device: tDCS intervention applied by Starstim device

What is being measured

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

  1. Percentage of incomplete and missed sessions (%)

    Feasibility will be evaluated using home-based data as recorded in the Neuroelectrics portal. Range [0,100]. Higher is worse

    Measured: From baseline to 4-week follow up across study subjects

  2. Incidence of Serious Adverse Events (SAE)

    Safety will be assessed by number and type of side effects

    Measured: From baseline to 4-week follow up across study subjects

  3. Median percentage change in Montgomery-Asberg Depression Mood Rating Scale (MADRS) scores

    The primary efficacy measure for this study will be the median percent change from baseline to the end of the 4-week post-treatment follow-up period in the observer-rated Montgomery-Asberg Depression Mood Rating Scale (MADRS) (Montgomery and Asberg, 1979). Range [0,100]. Higher is worse

    Measured: From baseline to 4-week follow up across study subjects

Secondary outcomes (4)

  1. Response rate

    Response rate is the secondary efficacy endpoint and will be calculated for the study subjects, where clinical response is defined as ≥ 50% improvement in Montgomery-Asberg Depression Mood Rating Scale (MADRS) score. Higher is better

    Measured: From baseline to the 4-week follow-up

  2. Change in the Quick Inventory of Depressive Symptomatology (QIDS-SR) score

    Range [0,27]. Higher is worse

    Measured: Change from baseline to 4-week follow-up in the participant-rated Quick Inventory of Depressive Symptomatology (QIDS-SR)

  3. Change in the Quality of Life Enjoyment and Satisfaction Questionnaire Short Form (Q-LES-Q-SF) score

    Range [14,70]. Higher is better

    Measured: Change from baseline to 4-week follow-up in the Quality of Life Enjoyment and Satisfaction Questionnaire Short Form (Q-LES-Q-SF)

  4. Median percentage change in Montgomery-Asberg Depression Mood Rating Scale (MADRS) scores

    Measured: From baseline to the end of week 4 of treatment, and to the end of week 8 of treatment.

Timeline

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

  1. First posted25 Jan 2022
  2. Study start2 Feb 2022
  3. Primary completionDec 2022 (estimated)
  4. Study completionDec 2022 (estimated)

Resources

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
Device feasibility
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
34 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05205915
Sponsor's protocol ID
NE02
Status last verified
Oct 2022
First submitted
20 Dec 2021
Last updated
5 Oct 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
Undecided

Publications

  • Ruffini G, Salvador R, Castaldo F, Baleeiro T, Camprodon JA, Chopra M, Cappon D, Pascual-Leone A. Multichannel tDCS with advanced targeting for major depressive disorder: a tele-supervised at-home pilot study. Front Psychiatry. 2024 Aug 15;15:1427365. doi: 10.3389/fpsyt.2024.1427365. eCollection 2024.

    PubMed 39211540

Questions about this trial

What is this clinical trial studying?

A study testing tDCS intervention applied by Starstim device in people with Major Depressive Disorder, run by Neuroelectrics Corporation at 4 sites in United States.

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 7 inclusion and 11 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 5 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. 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. 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of incomplete and missed sessions (%) (time frame: From baseline to 4-week follow up across study subjects). The study lists 3 primary outcomes in all. 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 NCT05205915, 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 5 Oct 2022; AzTrials last refreshed its copy on 31 Oct 2026.

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