Trial Outcomes & Findings for Closed-Loop Transcranial Alternating Current Stimulation for the Treatment of Depression (NCT NCT05772702)

NCT ID: NCT05772702

Last Updated: 2025-05-29

Results Overview

Change in HDRS-17 from Day 1 (D1) to Day 19 (i.e., two week follow-up; FU2); HDRS-17 minimum value is 0, maximum value is 52. Higher scores indicate worse outcome. Negative scores indicate improved outcomes.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 26 participants
• Primary outcome timeframe: Day 1 to Day 19 (i.e. 19 days)
• Results posted on: 2025-05-29

Participant Flow

Participant milestones

Measure	Closed-loop tACS Closed-loop individual alpha tACS daily for five consecutive days.
Overall Study STARTED	26
Overall Study COMPLETED	25
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Measure	Closed-loop tACS Closed-loop individual alpha tACS daily for five consecutive days.
Overall Study Adverse Event	1

Baseline Characteristics

Closed-Loop Transcranial Alternating Current Stimulation for the Treatment of Depression

Baseline characteristics by cohort

Measure	Closed-loop tACS n=25 Participants Closed-loop individual alpha tACS daily for five consecutive days.
Age, Continuous	40.1 Years STANDARD_DEVIATION 15.0 • n=5 Participants
Sex/Gender, Customized Female	20 Participants n=5 Participants
Sex/Gender, Customized Male	4 Participants n=5 Participants
Sex/Gender, Customized Gender nonconforming	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	24 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	18 Participants n=5 Participants
Race (NIH/OMB) More than one race	4 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Baseline HDRS-17 Score	17.18 units on a scale STANDARD_DEVIATION 4.19 • n=5 Participants
Baseline QIDS Score	14.72 units on a scale STANDARD_DEVIATION 2.67 • n=5 Participants
Baseline Q-LES-Q-SF Score	37.44 units on a scale STANDARD_DEVIATION 5.12 • n=5 Participants
Baseline ASRM Score	1.16 units on a scale STANDARD_DEVIATION 1.28 • n=5 Participants
Baseline SHAPS Score	5.52 units on a scale STANDARD_DEVIATION 3.27 • n=5 Participants
Baseline DASS-42 Score Overall Score	45.96 units on a scale STANDARD_DEVIATION 14.42 • n=5 Participants
Baseline DASS-42 Score Depression Subscale	23.12 units on a scale STANDARD_DEVIATION 6.31 • n=5 Participants
Baseline DASS-42 Score Anxiety Subscale	6.48 units on a scale STANDARD_DEVIATION 4.09 • n=5 Participants
Baseline DASS-42 Score Stress Subscale	16.36 units on a scale STANDARD_DEVIATION 9.34 • n=5 Participants
Baseline STAI Score	47.88 units on a scale STANDARD_DEVIATION 10.78 • n=5 Participants

PRIMARY outcome

Timeframe: Day 1 to Day 19 (i.e. 19 days)

Change in HDRS-17 from Day 1 (D1) to Day 19 (i.e., two week follow-up; FU2); HDRS-17 minimum value is 0, maximum value is 52. Higher scores indicate worse outcome. Negative scores indicate improved outcomes.

Outcome measures

Measure	Closed-loop tACS n=25 Participants Closed-loop individual alpha tACS daily for five consecutive days.
Change in Hamilton Depression Rating Scale 17-item (HDRS-17)	-12.04 units on a scale Standard Deviation 4.83

SECONDARY outcome

Timeframe: Day 1 to Day 5 (i.e., 5 days)

Change in HDRS-17 from Day 1 (D1) to Day 5 (D5); HDRS-17minimum value is 0, maximum value is 52. Higher scores indicate worse outcome. Negative scores indicate improved outcomes.

Outcome measures

Measure	Closed-loop tACS n=25 Participants Closed-loop individual alpha tACS daily for five consecutive days.
Change in Hamilton Depression Rating Scale 17-item (HDRS-17)	-8.36 score on a scale Standard Deviation 4.41

SECONDARY outcome

Timeframe: Day 5 and Day 19

Number of response/remission rates at Day 5 (D5) and Day 19 (i.e., two week follow-up; FU2). Response defined as >=50% reduction in HDRS-17 from D1. Remission defined as HDRS-17 score <=7.

Outcome measures

Measure	Closed-loop tACS n=25 Participants Closed-loop individual alpha tACS daily for five consecutive days.
Response/Remission of Depression Response at D5 · Met criteria	12 Participants
Response/Remission of Depression Response at D5 · Did not meet criteria	13 Participants
Response/Remission of Depression Response at FU2 · Met criteria	21 Participants
Response/Remission of Depression Response at FU2 · Did not meet criteria	4 Participants
Response/Remission of Depression Remission at D5 · Met criteria	10 Participants
Response/Remission of Depression Remission at D5 · Did not meet criteria	15 Participants
Response/Remission of Depression Remission at FU2 · Met criteria	21 Participants
Response/Remission of Depression Remission at FU2 · Did not meet criteria	4 Participants

SECONDARY outcome

Timeframe: Day 1 (D1) to Day 5 (D5); D1 to Day 12 (FU1); and D1 to Day 19 (FU2)

Change in QIDS at Day 5 (D5), Day 12 (i.e., one-week follow-up; FU1), and Day 19 (i.e., two-week follow-up; FU2); QIDS minimum value is 0, maximum value is 27. Higher scores indicate worse outcome. Negative scores indicate improved outcome.

Outcome measures

Measure	Closed-loop tACS n=25 Participants Closed-loop individual alpha tACS daily for five consecutive days.
Change in Quick Inventory of Depressive Symptomatology (QIDS) D5-D1	-3.88 score on a scale Standard Deviation 3.23
Change in Quick Inventory of Depressive Symptomatology (QIDS) FU1-D1	-5.96 score on a scale Standard Deviation 3.51
Change in Quick Inventory of Depressive Symptomatology (QIDS) FU2-D1	-7.48 score on a scale Standard Deviation 3.90

SECONDARY outcome

Timeframe: Day 1 (D1) to Day 5 (D5); D1 to Day 12 (FU1); and D1 to Day 19 (FU2)

Change in ASRM at Day 5 (D5), Day 12 (i.e., one week follow-up; FU1), and Day 19 (i.e., two week follow-up; FU2); ASRM minimum value is 0, maximum value is 20. Higher scores indicate worse outcome. Negative scores indicate improved outcome.

Outcome measures

Measure	Closed-loop tACS n=25 Participants Closed-loop individual alpha tACS daily for five consecutive days.
Change in Altman Self-Rating Mania Scale (ASRM) D5-D1	0.88 score on a scale Standard Deviation 1.81
Change in Altman Self-Rating Mania Scale (ASRM) FU1-D1	1.92 score on a scale Standard Deviation 1.93
Change in Altman Self-Rating Mania Scale (ASRM) FU2-D1	1.92 score on a scale Standard Deviation 1.89

SECONDARY outcome

Timeframe: Day 1 (D1) to Day 5 (D5); D1 to Day 12 (FU1); and D1 to Day 19 (FU2)

Change in SHAPS from Day 1 (D1) to Day 5 (D5), Day 12 (i.e., one week follow-up; FU1), and Day 19 (i.e., two week follow-up; FU2); SHAPS minimum value is 0, maximum value is 14. Higher scores indicate worse outcome. Negative scores indicate improved outcome.

Outcome measures

Measure	Closed-loop tACS n=25 Participants Closed-loop individual alpha tACS daily for five consecutive days.
Change in Snaith-Hamilton Pleasure Scale (SHAPS) D5-D1	-2.60 score on a scale Standard Deviation 2.61
Change in Snaith-Hamilton Pleasure Scale (SHAPS) FU1-D1	-3.48 score on a scale Standard Deviation 3.40
Change in Snaith-Hamilton Pleasure Scale (SHAPS) FU2-D1	-3.76 score on a scale Standard Deviation 3.44

SECONDARY outcome

Timeframe: Day 1 (D1) to Day 5 (D5); D1 to Day 12 (FU1); and D1 to Day 19 (FU2)

Change in DASS-42 from Day 1 (D1) to Day 5 (D5), Day 12 (i.e., one week follow-up; FU1), and Day 19 (i.e., two week follow-up; FU2); DASS-42 minimum value is 0, maximum value is 126 with three subscales (0 to 42). Higher scores indicate worse outcome. Negative scores indicate improved outcome.

Outcome measures

Measure	Closed-loop tACS n=25 Participants Closed-loop individual alpha tACS daily for five consecutive days.
Change in Depression Anxiety and Stress Scale (DASS-42) Overall: D5-D1	-12.52 score on a scale Standard Deviation 14.39
Change in Depression Anxiety and Stress Scale (DASS-42) Overall: FU1-D1	-21.44 score on a scale Standard Deviation 16.63
Change in Depression Anxiety and Stress Scale (DASS-42) Overall: FU2-D1	-24.08 score on a scale Standard Deviation 18.92
Change in Depression Anxiety and Stress Scale (DASS-42) Depression Subscale: D5-D1	-6.52 score on a scale Standard Deviation 8.15
Change in Depression Anxiety and Stress Scale (DASS-42) Depression Subscale: FU1-D1	-11.00 score on a scale Standard Deviation 7.53
Change in Depression Anxiety and Stress Scale (DASS-42) Depression Subscale: FU2-D1	-12.20 score on a scale Standard Deviation 8.90
Change in Depression Anxiety and Stress Scale (DASS-42) Anxiety Subscale: D5-D1	-1.88 score on a scale Standard Deviation 2.57
Change in Depression Anxiety and Stress Scale (DASS-42) Anxiety Subscale: FU1-D1	-2.84 score on a scale Standard Deviation 4.04
Change in Depression Anxiety and Stress Scale (DASS-42) Anxiety Subscale: FU2-D1	-3.64 score on a scale Standard Deviation 4.51
Change in Depression Anxiety and Stress Scale (DASS-42) Stress Subscale: D5-D1	-4.12 score on a scale Standard Deviation 6.73
Change in Depression Anxiety and Stress Scale (DASS-42) Stress Subscale: FU1-D1	-7.60 score on a scale Standard Deviation 8.99
Change in Depression Anxiety and Stress Scale (DASS-42) Stress Subscale: FU2-D1	-8.24 score on a scale Standard Deviation 9.47

SECONDARY outcome

Timeframe: Day 1 (D1) to Day 5 (D5); D1 to Day 12 (FU1); and D1 to Day 19 (FU2)

Change in STAI from Day 1 (D1) to Day 5 (D5), Day 12 (one week follow-up; FU1), and Day 19 (two week follow-up; FU2); STAI minimum value is 20, maximum value is 80. Higher scores indicate worse outcome. Negative scores indicate improved outcome.

Outcome measures

Measure	Closed-loop tACS n=25 Participants Closed-loop individual alpha tACS daily for five consecutive days.
Change in State-Train Anxiety Inventory (STAI) D5-D1	-3.08 score on a scale Standard Deviation 10.03
Change in State-Train Anxiety Inventory (STAI) FU1-D1	-5.16 score on a scale Standard Deviation 10.35
Change in State-Train Anxiety Inventory (STAI) FU2-D1	-6.16 score on a scale Standard Deviation 12.29

SECONDARY outcome

Timeframe: Day 1 (D1) to Day 5 (D5); D1 to Day 12 (FU1); and D1 to Day 19 (FU2)

Change in Q-LES-Q-SF from Day 1 (D1) to Day 5 (D5), Day 12 (i.e., one week follow-up; FU1), and Day 19 (i.e., two week follow-up; FU2); Q-LES-Q-SF minimum value is 14, maximum value is 70. Higher scores indicate better outcome. Negative scores indicate worse outcome.

Outcome measures

Measure	Closed-loop tACS n=25 Participants Closed-loop individual alpha tACS daily for five consecutive days.
Change in Quality of Life Enjoyment and Satisfaction Questionnaire, Short Form (Q-LES-Q-SF) D5-D1	6.86 score on a scale Standard Deviation 12.58
Change in Quality of Life Enjoyment and Satisfaction Questionnaire, Short Form (Q-LES-Q-SF) FU1-D1	15.36 score on a scale Standard Deviation 11.34
Change in Quality of Life Enjoyment and Satisfaction Questionnaire, Short Form (Q-LES-Q-SF) FU2-D1	16.57 score on a scale Standard Deviation 13.56

SECONDARY outcome

Timeframe: Severity: {Day 1 (D1), Day 5 (D5) and Day 19 (FU2)}; Global Improvement: {Day 5 (D5) and Day 19 (FU2)}

Change in CGI from Day 1 (D1) to Day 5 (D5) and Day 19 (i.e., two week follow-up; FU2); CGI scale contains two scoring components, 1) Severity of Illness (0-7) and 2) Global Improvement (0-7). Higher scores in component 1 indicate worse symptoms while higher numbers in component 2 indicate worse clinical outcomes.

Outcome measures

Measure	Closed-loop tACS n=25 Participants Closed-loop individual alpha tACS daily for five consecutive days.
Change in Clinical Global Impression Scale (CGI) Global Improvement at D5	2.56 units on a scale Standard Deviation 1.16
Change in Clinical Global Impression Scale (CGI) Global Improvement at FU2	1.68 units on a scale Standard Deviation 0.75
Change in Clinical Global Impression Scale (CGI) Severity at D1	4.04 units on a scale Standard Deviation 0.79
Change in Clinical Global Impression Scale (CGI) Severity at D5	2.36 units on a scale Standard Deviation 1.19
Change in Clinical Global Impression Scale (CGI) Severity at FU2	1.76 units on a scale Standard Deviation 0.93

OTHER_PRE_SPECIFIED outcome

Timeframe: 19 days

Change in EEG alpha oscillation power at D1 pre-stimulation, D1 post-stimulation, and FU2.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 89 days

Change in QIDS at four week follow-up (FU3), six week follow-up (FU4), eight week follow-up (FU5), ten week follow-up (FU6), and twelve week follow-up (FU7); minimum value is 0, maximum value is 27. Higher scores indicate worse outcome.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 89 days

Change in ASRM at FU3, FU4, FU5, FU6, and FU7; minimum value is 0, maximum value is 20. Higher scores indicate worse outcome.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 89 days

Change in SHAPS at FU3, FU4, FU5, FU6, and FU7; minimum value is 0, maximum value is 14. Higher scores indicate worse outcome.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 89 days

Change in DASS-42 at FU3, FU4, FU5, FU6, and FU7; minimum value is 0, maximum value is 126 with three subscales (0 to 42). Higher scores indicate worse outcome.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 89 days

Change in STAI at FU3, FU4, FU5, FU6, and FU7; minimum value is 20, maximum value is 80. Higher scores indicate worse outcome.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 89 days

Change in Q-LES-Q-SF at FU3, FU4, FU5, FU6, and FU7; minimum value is 14, maximum value is 70. Higher scores indicate better outcome.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 47 Days

Change in HDRS-17 between six week follow up (FU4) and D1

Outcome measures

Outcome data not reported

Adverse Events

Closed-loop tACS

Serious events: 0 serious events

Other events: 21 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Closed-loop tACS n=26 participants at risk Closed-loop individual alpha tACS daily for five consecutive days.
Gastrointestinal disorders Nausea	7.7% 2/26 • Number of events 2 • Adverse event data were collected across the full study participation (89 days). A structured adverse event was administered on D5 for all participants and for any AE spontaneously reported by a participant.
Gastrointestinal disorders Vomiting	3.8% 1/26 • Number of events 1 • Adverse event data were collected across the full study participation (89 days). A structured adverse event was administered on D5 for all participants and for any AE spontaneously reported by a participant.
Gastrointestinal disorders Diarrhea	11.5% 3/26 • Number of events 3 • Adverse event data were collected across the full study participation (89 days). A structured adverse event was administered on D5 for all participants and for any AE spontaneously reported by a participant.
Nervous system disorders Headache	50.0% 13/26 • Number of events 13 • Adverse event data were collected across the full study participation (89 days). A structured adverse event was administered on D5 for all participants and for any AE spontaneously reported by a participant.
Skin and subcutaneous tissue disorders Skin irritation	11.5% 3/26 • Number of events 3 • Adverse event data were collected across the full study participation (89 days). A structured adverse event was administered on D5 for all participants and for any AE spontaneously reported by a participant.
General disorders Scalp/neck pain	7.7% 2/26 • Number of events 2 • Adverse event data were collected across the full study participation (89 days). A structured adverse event was administered on D5 for all participants and for any AE spontaneously reported by a participant.
Nervous system disorders Dizziness	7.7% 2/26 • Number of events 2 • Adverse event data were collected across the full study participation (89 days). A structured adverse event was administered on D5 for all participants and for any AE spontaneously reported by a participant.
General disorders Fatigue	50.0% 13/26 • Number of events 13 • Adverse event data were collected across the full study participation (89 days). A structured adverse event was administered on D5 for all participants and for any AE spontaneously reported by a participant.
Musculoskeletal and connective tissue disorders Muscle cramps	3.8% 1/26 • Number of events 1 • Adverse event data were collected across the full study participation (89 days). A structured adverse event was administered on D5 for all participants and for any AE spontaneously reported by a participant.

Additional Information

Dr. Christopher Walker

Pulvinar Neuro

Phone: 8043173403

Email: chris.walker@pulvinarneuro.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60