An interventional study of tDCS in Major Depressive Disorder, sponsored by Hebrew SeniorLife. Completed at 1 site in United States. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2022-03-24.
Sponsored by Hebrew SeniorLife · Not applicable, Interventional, and Treatment
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.
This is an open-label pilot feasibility telemedicine study. This pilot will involve a total of 37 stimulations sessions / at home visits (30- minute sessions of multichannel excitatory tDCS targeting the left DPFC) and the maintenance of a daily treatment diary to be completed by the subjects immediately after enrollment and 12 weeks following the last study visit.
4,845 studies on the registry are indexed under Depressive Disorder; 514 are open to participants now.
This study's enrollment of 5 is below the median of 80 across 3,999 interventional studies indexed under Depressive Disorder.
Browse Depressive Disorder studies →Hebrew SeniorLife is the lead sponsor of 36 studies on the registry; 6 are open to participants now.
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Patients meeting one of the following criteria may be eligible to participate in this study.
The benefits of this project address a present need due to the COVID-19 pandemic, but also go beyond the present situation and address a larger, pre-existing need. Across all these potential groups of participants, prospective participants will:
Inclusion Criteria:
Individuals with MDD
Participants will be men and women who:
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
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):
Further, participants must:
Further, participants must have a willing and eligible caregiver-administrators who is:
Exclusion Criteria:
Exclusion criteria for participants with MDD will be:
Understanding will be assessed by asking the participant with MDD to answer the following three questions:
Exclusion criteria for Participant caregiver-administrators:
Understanding will be assessed by asking the participant caregiver-administrator to answer the following three questions:
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
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)
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).
Time frame: 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
Time frame: 12 weeks
The Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF)
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 by 12 weeks.
Time frame: 12 weeks
The Quick Inventory of Depressive Symptomatology (16-Item) (Self-Report)(QIDS-SR16)
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, which ranges from 0 to 27. 1-5 = No depression 6-10 = Mild depression 11-15 = Moderate depression 16-20 = Severe depression 21-27 = Very severe depression This measure was administered at baseline and at 1 month follow-up, which were separated by 12 weeks.
Time frame: 12 weeks
Beck Depression Inventory (BDI)
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.
Time frame: 12 weeks
Hamilton Depression Rating Scale
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.
Time frame: 12 weeks
Montreal Cognitive Assessment (MoCA)
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).
Time frame: 12 weeks
Digit Span Forward
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.
Time frame: 12 weeks
Digit Span Backward
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.
Time frame: 12 weeks
| Milestone | tDCS MDD |
|---|---|
| Started | 5 |
| Completed | 3 |
| Not completed | 2 |
| Withdrew: Withdrawal by subject | 2 |
| Milestone | tDCS MDD |
|---|---|
| Started | 3 |
| Completed | 3 |
| Not completed | 0 |
| Milestone | tDCS MDD |
|---|---|
| Started | 3 |
| Completed | 3 |
| Not completed | 0 |
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).
| units on a scale | tDCS MDD |
|---|---|
| Montgomery-Asberg Depression Rating Scale (MADRS) | 16 (6 to 25) |
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 sessions/events | tDCS MDD |
|---|---|
| Number of missed sessions | 1 |
| Number of treatment-emergent adverse events | 0 |
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 by 12 weeks.
| units on a scale | tDCS MDD |
|---|---|
| The Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF) | 44.6667 (42 to 48) |
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, which ranges from 0 to 27. 1-5 = No depression 6-10 = Mild depression 11-15 = Moderate depression 16-20 = Severe depression 21-27 = Very severe depression This measure was administered at baseline and at 1 month follow-up, which were separated by 12 weeks.
| units on a scale | tDCS MDD |
|---|---|
| The Quick Inventory of Depressive Symptomatology (16-Item) (Self-Report)(QIDS-SR16) | 5.3333 (0 to 10) |
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.
| units on a scale | tDCS MDD |
|---|---|
| Beck Depression Inventory (BDI) | 10.3333 (2 to 18) |
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.
| units on a scale | tDCS MDD |
|---|---|
| Hamilton Depression Rating Scale | 7.3333 (1 to 14) |
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).
| units on a scale | tDCS MDD |
|---|---|
| Montreal Cognitive Assessment (MoCA) | 28.6667 (28 to 30) |
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.
| Count of numbers correctly recalled | tDCS MDD |
|---|---|
| Digit Span Forward | 8 (7 to 9) |
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.
| Count of numbers correctly recalled | tDCS MDD |
|---|---|
| Digit Span Backward | 6 (4 to 8) |
Collected over 6 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| tDCS MDD | 0/5 (0%) | 0/5 (0%) | 0/5 (0%) |
| Age, Continuous(years) | tDCS MDD |
|---|---|
| Mean | 63.2 ± 10.5 |
| Sex: Female, Male(Participants) | tDCS MDD |
|---|---|
| Female | 0 |
| Male | 5 |
| Race (NIH/OMB)(Participants) | tDCS MDD |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 5 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Montgomery-Asberg Depression Rating Scale (MADRS)(units on a scale) | tDCS MDD |
|---|---|
| Mean | 35 (27 to 44) |
| Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF)(units on a scale) | tDCS MDD |
|---|---|
| Mean | 33.2 (30 to 36) |
| Quick Inventory of Depressive Symptomatology (16-Item) (Self-Report)(QIDS-SR16)(units on a scale) | tDCS MDD |
|---|---|
| Mean | 17.6 (12 to 26) |
| Beck Depression Inventory (BDI)(units on a scale) | tDCS MDD |
|---|---|
| Mean | 24.8 (17 to 36) |
| Hamilton Depression Rating Scale (HDRS)(units on a scale) | tDCS MDD |
|---|---|
| Mean | 19.8 (14 to 24) |
3 further baseline measures are reported on the registry.
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
This study is completed, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.
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