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

Depression Clinical Trial

— CLACS  

Official title:

Closed-Loop Transcranial Alternating Current Stimulation for the Treatment of Depression (CLACS): Single-Site Open-Label Pilot Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05772702
• Other study ID #: 22-3094
• Status: Recruiting
• Phase: N/A
• Start date: February 13, 2023
• Est. completion date: August 15, 2024

Study information

• Verified date: January 2024
• Source: Electromedical Products International, Inc.
• Contact: Tobias U Schwippel, MD
• Phone: 817-609-4460
• Email: tobias_schwippel[@]unc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this research study is to study closed-loop transcranial alternating current stimulation (tACS) to determine its effects on symptoms of depression in people with major depressive disorder.

Description:

The purpose of this clinical trial is to investigate the preliminary efficacy of closed-loop tACS for the treatment of major depressive disorder (MDD) in an open-label pilot study. We will recruit up to 35 participants with unipolar, non-psychotic MDD. Participation will include seven visits, two of them remotely (with an in-person option as needed), and one electronic survey. Potential participants fill-in an electronic pre-screening form. If potentially eligible, a remote screening visit is performed. If eligible, participants attend five consecutive, daily stimulation sessions. Clinical assessments will be performed at baseline (Day 1 of stimulation, D1), Day five of stimulation (D5), and at their follow-up visit (14 days after the completion of stimulation, FU2) using the Hamilton Depression Rating Scale (HDRS-17). For a subset of patients, electroencephalography (EEG) is collected at D1 prior to stimulation and after stimulation and again at FU2. For a subset of patients, self-scoring surveys will be sent bi-weekly until 12 weeks after treatment.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 35
• Est. completion date: August 15, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Ages 18-70 years
• Diagnostic and Statistical Manual, 5th Edition (DSM-5) diagnosis of MDD; unipolar, non-psychotic
• Hamilton Rating Depression Rating Scale (HRDS-17) score >8
• Low suicide risk as determined by the Columbia-Suicide Severity Rating Scale (C-SSRS) triage form (no intent or plan)
• Capacity to understand all relevant risks and potential benefits of the study (informed consent)

Exclusion Criteria:

• DSM-5 diagnosis of severe alcohol use disorder (AUD) within the last 12 months.
• DSM-5 diagnosis of moderate to severe substance use disorder (excluding tobacco) within the last 12 months.
• Lifetime history of bipolar disorder, psychotic disorder, schizophrenia, autism
• Current use of benzodiazepines > 20mg diazepam/d equivalent
• Antidepressant dose change within the last 2 weeks
• Initiated new antidepressant within the last 4 weeks

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

Device:
• Closed-loop tACS
Individual alpha tACS

Locations

Country	Name	City	State
United States	Carolina Center for Neurostimulation	Chapel Hill	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Electromedical Products International, Inc.	University of North Carolina, Chapel Hill

Country where clinical trial is conducted

United States, 

References & Publications (1)

Alexander ML, Alagapan S, Lugo CE, Mellin JM, Lustenberger C, Rubinow DR, Frohlich F. Double-blind, randomized pilot clinical trial targeting alpha oscillations with transcranial alternating current stimulation (tACS) for the treatment of major depressive disorder (MDD). Transl Psychiatry. 2019 Mar 5;9(1):106. doi: 10.1038/s41398-019-0439-0. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in Alpha Oscillation Power	Change in EEG alpha oscillation power at D1 pre-stimulation, D1 post-stimulation, and FU2.	21 days
Other	Change in Quick Inventory of Depressive Symptomatology (QIDS) Over 12 Weeks	Change in QIDS at D5, FU1, FU2, 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.	91 days
Other	Change in Altman Self-Rating Mania Scale (ASRM) Over 12 Weeks	Change in ASRM at D5, FU1, FU2, FU3, FU4, FU5, FU6, and FU7; minimum value is 0, maximum value is 20. Higher scores indicate worse outcome.	91 days
Other	Change in Snaith-Hamilton Pleasure Scale (SHAPS) Over 12 Weeks	Change in SHAPS at D5, FU1, FU2, FU3, FU4, FU5, FU6, and FU7; minimum value is 0, maximum value is 14. Higher scores indicate worse outcome.	91 days
Other	Change in Depression Anxiety and Stress Scale (DASS-42) Over 12 Weeks	Change in DASS-42 at D5, FU1, FU2, 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.	91 days
Other	Change in State-Train Anxiety Inventory (STAI) Over 12 Weeks	Change in STAI at D5, FU1, FU2, FU3, FU4, FU5, FU6, and FU7; minimum value is 20, maximum value is 80. Higher scores indicate worse outcome.	91 days
Other	Change in Quality of Life Enjoyment and Satisfaction Questionnaire, short form (Q-LES-Q-SF)	Change in Q-LES-Q-SF at D5, FU1, FU2, FU3, FU4, FU5, FU6, and FU7; minimum value is 14, maximum value is 70. Higher scores indicate better outcome.	91 days
Primary	HDRS-17 change	Change in HDRS-17 between two week follow-up (FU2) and Day 1 (D1); minimum value is 0, maximum value is 52. Higher scores indicate worse outcome.	21 days
Secondary	HDRS-17 change	Change in HDRS-17 between one week follow-up (FU1) and D1	14 days
Secondary	HDRS-17 change	Change in HDRS-17 between D5 and D1	5 days
Secondary	Response/Remission of depression	Number of response/remission rates at D5, FU1 and FU2	21 days
Secondary	Change in Quick Inventory of Depressive Symptomatology (QIDS)	Change in QIDS at D5, FU1, FU2; minimum value is 0, maximum value is 27. Higher scores indicate worse outcome.	21 days
Secondary	Change in Altman Self-Rating Mania Scale (ASRM)	Change in ASRM at D5, FU1, FU2; minimum value is 0, maximum value is 20. Higher scores indicate worse outcome.	21 days
Secondary	Change in Snaith-Hamilton Pleasure Scale (SHAPS)	Change in SHAPS at D5, FU1, FU2; minimum value is 0, maximum value is 14. Higher scores indicate worse outcome.	21 days
Secondary	Change in Depression Anxiety and Stress Scale (DASS-42)	Change in DASS-42 at D5, FU1, FU2; minimum value is 0, maximum value is 126 with three subscales (0 to 42). Higher scores indicate worse outcome.	21 days
Secondary	Change in State-Train Anxiety Inventory (STAI)	Change in STAI at D5, FU1, FU2; minimum value is 20, maximum value is 80. Higher scores indicate worse outcome.	21 days
Secondary	Change in Quality of Life Enjoyment and Satisfaction Questionnaire, short form (Q-LES-Q-SF)	Change in Q-LES-Q-SF at D5, FU1, FU2; minimum value is 14, maximum value is 70. Higher scores indicate better outcome.	21 days
Secondary	Change in Clinical Global Impression Scale (CGI)	Change in CGI at Day 5, FU1 and 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.	21 days

External Links

•   Link to more information and study recruitment for interested potential participants.