NCT04799405: MoodStim

Home-based tDCS in Major Depressive Disorder

Completed NA Results posted Last updated 24 March 2022

What this trial tests

NA trial testing tDCS in Major Depressive Disorder in 5 participants. Completed in 2 July 2021.

Timeline

24 September 2020

Primary endpoint
2 July 2021

2 July 2021

Quick facts

Lead sponsor	Hebrew SeniorLife
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	5
Start date	24 September 2020
Primary completion	2 July 2021
Estimated completion	2 July 2021
Sites	1 location across United States

Drugs / interventions tested

• tDCS — full drug profile →

Conditions studied

• Major Depressive Disorder — all drugs for Major Depressive Disorder →

Sponsor

Hebrew SeniorLife — full company profile →

Who can join

50 and older, any sex, with Major Depressive Disorder. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Montgomery-Asberg Depression Rating Scale (MADRS) Primary · 12 weeks

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 - moder

Group	Value	95% CI
tDCS MDD	16	6 – 25

Number of Treatment-Emergent Adverse Events [Safety and Tolerability] and Missed Sessions Primary · 12 weeks

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

Number of missed sessions

Group	Value	95% CI
tDCS MDD	1

Number of treatment-emergent adverse events

Group	Value	95% CI
tDCS MDD	0

The Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF) Secondary · 12 weeks

The Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF) is a 16 item questionnaire that captures life satisfaction over the past week across several domains. Each question is rated on a 5 point scale from 1 (Very Poor) to 5 (Very Good). The Total Score is reported as percentage maximum possible % Max = Raw-minimum score/maximum score-minimum score. (Raw score minus the minimum possible raw score divided by the maximum possible raw score minus the minimum possible raw score). This measure was administered at baseline and at 1 month follow-up, which were separated

Group	Value	95% CI
tDCS MDD	44.6667	42 – 48

The Quick Inventory of Depressive Symptomatology (16-Item) (Self-Report)(QIDS-SR16) Secondary · 12 weeks

The Quick Inventory of Depressive Symptomatology (16-Item) (Self-Report)(QIDS-SR16) is a self-report measure of depressed symptomology. Questions in the QIDS - SR-16 correlate with the nine DSM-IV symptom criterion domains, Including: Sleep disturbance (initial, middle, and late insomnia or hypersomnia) (Q 1 - 4), Sad mood (Q 5), Decrease/increase in appetite/weight (Q 6 - 9), Concentration (Q 10), Self-criticism (Q 11), Suicidal ideation (Q 12), Interest (Q 13), Energy/fatigue (Q 14), Psychomotor agitation/retardation (Q 15 - 16). Severity of depression can be judged based on the total score,

Group	Value	95% CI
tDCS MDD	5.3333	0 – 10

Beck Depression Inventory (BDI) Secondary · 12 weeks

The Beck Depression Inventory (BDI) is 21-item multiple-choice self-report inventory, one of the most widely used instruments for measuring the severity of depression. For each item, a value of 0 to 3 is assigned and then the total score is summed. The standard cut-offs are as follows: 0-9: indicates minimal depression 10-18: indicates mild depression 19-29: indicates moderate depression 30-63: indicates severe depression. Higher total scores indicate more severe depressive symptoms. This scale was given at baseline and 12 weeks later at the 1-month follow-up visit.

Group	Value	95% CI
tDCS MDD	10.3333	2 – 18

Hamilton Depression Rating Scale Secondary · 12 weeks

Hamilton Depression Rating Scale (HDRS) is comprised of 21 items for inquiry, and only the first 17 are used in scoring. Each question examines a different symptom or aspect of depression, including: mood, guilt, suicidal ideation, insomnia, agitation, and somatic symptoms. Items are scaled either from 0 - 2 or 0 - 4, and each item is summed for a total score. Benchmarks suggested at: 0-7 normal; 8 - 13 mild depression; 14-18 moderate depression; 19-22 severe depression ; \>=23 very severe depression. This scale was administered at baseline and 12 weeks later at the 1-month follow-up visit.

Group	Value	95% CI
tDCS MDD	7.3333	1 – 14

Montreal Cognitive Assessment (MoCA) Secondary · 12 weeks

The Montreal Cognitive Assessment (MoCA) is designed as a rapid screening instrument for mild cognitive dysfunction. It assesses different cognitive domains. The total possible score is 30 points; a score of 26 or above is considered normal. Severity of impairment can be determined with the following scores: 18-25 = mild cognitive impairment, 10-17= moderate cognitive impairment, and less than 10= severe cognitive impairment. The maximum total score is 30 and the minimum total score is 0 points. This assessment was administered at baseline and at 1 month post-intervention (12 week span).

Group	Value	95% CI
tDCS MDD	28.6667	28 – 30

Digit Span Forward Secondary · 12 weeks

A digit-span forward task measures working memory storage capacity of numbers. Participants are auditorily presented with a chain of numerical digits and are instructed to recall the sequence of numbers verbally in the order that it was presented to the participant. The number of digits on the first trial is three. The length of the sequence increases with each correct trial completion. The more numbers recalled the better a participants has done.

Group	Value	95% CI
tDCS MDD	8	7 – 9

Digit Span Backward Secondary · 12 weeks

A digit-span task backwards measures working memory storage capacity of numbers. Participants are auditorily presented with a chain of numerical digits and are instructed to recall the sequence of numbers verbally in backwards order. The number of digits on the first trial is two. The length of the sequence increases with each correct trial completion. The more numbers recalled the better a participants has done.

Group	Value	95% CI
tDCS MDD	6	4 – 8

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Safety and Feasibility of Tele-Supervised Home-Based Transcranial Direct Current Stimulation for Major Depressive Disorder.
   Cappon D, den Boer T, Jordan C, Yu W, et al · · 2021 · cited 45× · PMID 35185515 · DOI 10.3389/fnagi.2021.765370
2. An Educational Program for Remote Training and Supervision of Home-Based Transcranial Electrical Stimulation: Feasibility and Preliminary Effectiveness.
   Cappon D, den Boer T, Yu W, LaGanke N, et al · · 2024 · cited 11× · PMID 37552152 · DOI 10.1016/j.neurom.2023.04.477