Non-invasive Brain Stimulation in Subjects with Major Depressive Disorder
NCT06714643, Not applicable, Not yet recruiting, Carmen Concerto
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Non-invasive Brain Stimulation in Subjects with Major Depressive Disorder | ClinicalTrials.gov |
| NCT number | NCT06714643 | ClinicalTrials.gov |
| Status | Not yet recruiting | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 105 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Carmen Concerto | ClinicalTrials.gov |
| Conditions | Major Depressive Disorder (MDD) | ClinicalTrials.gov |
| Interventions | Active tDCS, Sham treatment | ClinicalTrials.gov |
| First posted | 2024-12-03 | ClinicalTrials.gov |
| Last updated | 2024-12-03 | ClinicalTrials.gov |
Registered outcomes 8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Hamilton Depression Rating Scale - 17 (HDRS-17) | From enrollment to the end of treatment at 6 months | To investigate the effects of transcranial direct current stimulation (tDCS) treatment by administering Hamilton Depression Rating Scale - 17 (HDRS-17) on depressive symptoms in patients with depression, randomized into a "test" group and a "sham" group. Higher scores indicate greater severity of depressive symptoms, and thus a worse outcome. The minimum and maximum scores and their meaning are as follows: 0-7: No clinically significant depression; 8-13: mild depression; 14-18: moderate depression; 19-22: severe depression; 23-52: very severe depression. | ClinicalTrials.gov |
| Secondary | Montreal Cognitive Assessment (MOCA) | From enrollment to the end of treatment at 6 months | To investigate the effects of tDCS treatment on cognitive function in patients with depression, randomized into a "test" group and a "sham" group. Lower scores suggest greater cognitive impairment, while higher scores indicate better cognitive performance. Below are the minimum and maximum scores and their meaning: 30-26: normal cognitive function; 25-18: mild cognitive impairment; 17-10: moderate cognitive impairment; 9-0: severe cognitive impairment. | ClinicalTrials.gov |
| Secondary | Frontal Assessment Battery (FAB) | From enrollment to the end of treatment at 6 months | To investigate the effects of tDCS treatment on cognitive function in patients with depression, randomized into a "test" group and a "sham" group. Specifically, FAB is a tool used to evaluate frontal lobe functions, such as executive functioning. Lower scores suggest greater impairment of frontal lobe functions, while higher scores indicate better functioning. Below are the minimum and maximum scores and their meaning: 18-15: normal frontal lobe functioning; 14-12: mild impairment; 11-9: moderate impairment; 9-0: severe impairment. | ClinicalTrials.gov |
| Secondary | Apathy Evaluation Scale (AS) | From enrollment to the end of treatment at 6 months | To investigate the effects of tDCS treatment on cognitive function in patients with depression, randomized into a "test" group and a "sham" group. AS is a tool used to assess the presence of apathy in patients. Higher scores suggest greater severity of apathy, while lower scores indicate better motivation and engagement. Below are the minimum and maximum scores and their meaning: 18-27: no clinically significant apathy; 28-41: mild apathy; 42-55: moderate apathy; 56-72: severe apathy. | ClinicalTrials.gov |
| Secondary | Stroop Color Test | From enrollment to the end of treatment at 6 months | To investigate the effects of tDCS treatment on cognitive function in patients with depression, randomized into a "test" group and a "sham" group. Stroop Color Test is a neuropsychological tool used to assess cognitive flexibility, selective attention and processing speed. Performance is assessed by comparing raw scores to normative data adjusted for age, education and cultural background. Minimum score (0) indicates no ability to perform the task; on the other hand, there is no universal maximum score. Tipically, performance is categorized into a normal range when it is consistent with age-matched norms; mild impairment when the performance is slightly below expectations for age or education; moderate to severe impairment when patient shows significant difficulty with cognitive control or selective attention. | ClinicalTrials.gov |
| Secondary | To evaluate changes in blood biomarkers after tDCS treatment | From enrollment to the end of treatment at 6 months | A blood sample is collected at enrollment and after tDCS/sham treatment to evaluate biomarkers, including BDNF, NGF, VEGF, IGF1, Ang, Nrg1, IL-6, and TNFα. Concentrations will be reported in pg/mL or ng/mL, as appropriate for each biomarker. | ClinicalTrials.gov |
| Secondary | To evaluate changes in cerebral hemodynamics after tDCS treatment | From enrollment to the end of treatment at 6 months | A transcranial Doppler (TCD) exam is conducted to assess cerebral hemodynamics. Parameters including VPS (cm/s), EDV (cm/s), MBFV (cm/s), PI (unitless), and RI (unitless) are recorded bilaterally from the middle cerebral arteries and the basilar artery, both at rest and after breath-holding tests. Measurements will be reported in their respective units (e.g., cm/s for velocities, unitless for indices). | ClinicalTrials.gov |
| Secondary | To evaluate changes in Cortical Excitability Using TMS | From enrollment to the end of treatment at 6 months | Cortical excitability is evaluated using transcranial magnetic stimulation (TMS) with single- and double-pulse protocols. Parameters include: Resting motor threshold (rMT, % of maximum stimulator output); Cortical silent period (cSP, milliseconds); Motor evoked potential (MEP, µV); Paired-pulse stimulation (BiSTIM) is used to study inhibitory and excitatory circuits, including intracortical inhibition (ICI) and intracortical facilitation (ICF). Results are reported in their respective units (e.g., % stimulator output for rMT, ms for cSP, µV for MEP). | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 1
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Stroop Color-Word Test | Secondary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)