Effectiveness of CES on Emotional and Cellular Wellbeing

NCT03369418 | Completed Results FDA Device

• 1 other identifier: 15-001639
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators aim to use a CES (cranial electrotherapy stimulation) intervention to improve emotional well-being by reducing symptoms of anxiety and depression and to assess for changes in markers of cellular health - specifically, telomere length and telomerase activity

Conditions

Anxiety; Depression

Outcome Measures

Primary Outcomes (1)

• HADS Questionnaire Combined Score

  The Hospital anxiety and depression scale (HADS) evaluates symptoms of anxiety and depression, minimum 0 and maximum 52 with higher scores indicating more symptoms. A combined score it utilized as the primary outcome measure, summing the scores for anxiety and depression.

  After completion of the study (1 year)

Secondary Outcomes (1)

• Telomere Length

  After completion of the study (1 year)

Study Arms (2)

Active

ACTIVE COMPARATOR

Subjects will be given an Alpha-Stim active device for daily treatment. The electrodes attached to the device will be active. The device frequency is preset to 0.5 Hz and 100 microampere and treatment is one hour daily. The subjects will be instructed that the device is set to a low level so that the current is not detectable but should still be effective. The current will not be detectable in both active and sham devices in order for adequate blinding to occur.

Device: Alpha-Stim Active

Inactive

SHAM COMPARATOR

Subjects will be given an Alpha-Stim inactive device for daily treatment. The electrodes attached to the device will be inactive. The device will not transmit anything when turned on because the electrodes are inactive. The frequency on the device will state 0.5 Hz and 100 microampere but it will not actually emit anything. Subjects in this group will receive "treatment" one hour daily. The subjects will be instructed that the device is set to a low level so that the current is not detectable but should still be effective. The current will not be detectable in both active and sham devices in order for adequate blinding to occur.

Device: Alpha-Stim Inactive

Interventions

Alpha-Stim Active DEVICE

The study device is a safe, commercially available take-home cranial electrotherapy stimulation device that applies an electrical current to a subject's head to treat anxiety, depression or insomnia

Active

Alpha-Stim Inactive DEVICE

The study device given to the inactive group will be identical to the active except the electrodes attached to the device will be inactive. The device will not transmit anything when turned on because the electrodes are inactive.

Inactive

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male
• Within the age range of 18-40 years old
• Score 8-14 on either the anxiety or depression HADS scale as defined as mild (8-10) to moderate (11-14)
• Subjects who receive anxiety, depression, psychiatric or mental health treatment (pharmacological or non-pharmacological) must be on a stable regimen for the past 3 months
• No active suicidal ideation or psychosis (including schizophrenia and bipolar disorder)
• No uncontrolled or progressive severe medical illness (e.g., cancer, uncontrolled diabetes mellitus, active cardiac disease)
• No use of a pacemaker or any other implanted electrical device
• No alcohol consumption greater than 2 units daily
• Ability to independently complete the in-person study questionnaires and sign informed consent form (ICF) without assistance
• Willing to comply with all study procedures and be available for the duration of the study
• No participation in another clinical trial study

You may not qualify if:

• Not a male
• Younger than 18 years old or older than 40 years old
• Score ≥15 on either the anxiety or depression HADS scale as defined as severe (15-20)
• Subject who receive anxiety, depression, psychiatric or mental health treatment (pharmacological or non-pharmacological) who have not been on a stable regimen for the past 3 months
• Active suicidal ideation or psychosis (including schizophrenia and bipolar disorder)
• History of inpatient treatment or suicidal ideation within the last year
• Use of a pacemaker or any other implanted electrical device
• Unable to independently complete the in-person study questionnaires and sign ICF due to impaired cognitive function
• Unwilling to comply with all study procedures
• Unavailable for the duration of the study
• Current participation in another clinical trial study
• Any other condition that the investigator believes would jeopardize the safety or rights of the subject or would render the subject unable to comply with the study protocol or make use of acquired data non-analyzable

Sponsors & Collaborators

• University of California, Los Angeles: lead

Study Sites (1)

University of California, Los Angeles (UCLA)

Los Angeles, California, 90025, United States

Location

Related Publications (10)

• Verhoeven JE, Revesz D, Wolkowitz OM, Penninx BW. Cellular aging in depression: Permanent imprint or reversible process?: An overview of the current evidence, mechanistic pathways, and targets for interventions. Bioessays. 2014 Oct;36(10):968-78. doi: 10.1002/bies.201400068. Epub 2014 Aug 20.

  PMID: 25143317 BACKGROUND

• Simon NM, Smoller JW, McNamara KL, Maser RS, Zalta AK, Pollack MH, Nierenberg AA, Fava M, Wong KK. Telomere shortening and mood disorders: preliminary support for a chronic stress model of accelerated aging. Biol Psychiatry. 2006 Sep 1;60(5):432-5. doi: 10.1016/j.biopsych.2006.02.004. Epub 2006 Apr 11.

  PMID: 16581033 BACKGROUND

• van Ockenburg SL, de Jonge P, van der Harst P, Ormel J, Rosmalen JG. Does neuroticism make you old? Prospective associations between neuroticism and leukocyte telomere length. Psychol Med. 2014 Mar;44(4):723-9. doi: 10.1017/S0033291713001657. Epub 2013 Jul 9.

  PMID: 23834823 BACKGROUND

• Teyssier JR, Chauvet-Gelinier JC, Ragot S, Bonin B. Up-regulation of leucocytes genes implicated in telomere dysfunction and cellular senescence correlates with depression and anxiety severity scores. PLoS One. 2012;7(11):e49677. doi: 10.1371/journal.pone.0049677. Epub 2012 Nov 21.

  PMID: 23185405 BACKGROUND

• Jergovic M, Tomicevic M, Vidovic A, Bendelja K, Savic A, Vojvoda V, Rac D, Lovric-Cavar D, Rabatic S, Jovanovic T, Sabioncello A. Telomere shortening and immune activity in war veterans with posttraumatic stress disorder. Prog Neuropsychopharmacol Biol Psychiatry. 2014 Oct 3;54:275-83. doi: 10.1016/j.pnpbp.2014.06.010. Epub 2014 Jun 28.

  PMID: 24977331 BACKGROUND

• Barclay TH, Barclay RD. A clinical trial of cranial electrotherapy stimulation for anxiety and comorbid depression. J Affect Disord. 2014 Aug;164:171-7. doi: 10.1016/j.jad.2014.04.029. Epub 2014 Apr 21.

  PMID: 24856571 BACKGROUND

• Kirsch DL, Nichols F. Cranial electrotherapy stimulation for treatment of anxiety, depression, and insomnia. Psychiatr Clin North Am. 2013 Mar;36(1):169-76. doi: 10.1016/j.psc.2013.01.006.

  PMID: 23538086 BACKGROUND

• Lande RG, Gragnani C. Efficacy of cranial electric stimulation for the treatment of insomnia: a randomized pilot study. Complement Ther Med. 2013 Feb;21(1):8-13. doi: 10.1016/j.ctim.2012.11.007. Epub 2012 Dec 21.

  PMID: 23374200 BACKGROUND

• Taylor AG, Anderson JG, Riedel SL, Lewis JE, Kinser PA, Bourguignon C. Cranial electrical stimulation improves symptoms and functional status in individuals with fibromyalgia. Pain Manag Nurs. 2013 Dec;14(4):327-335. doi: 10.1016/j.pmn.2011.07.002. Epub 2011 Oct 6.

  PMID: 24315255 BACKGROUND

• Lee SH, Kim WY, Lee CH, Min TJ, Lee YS, Kim JH, Park YC. Effects of cranial electrotherapy stimulation on preoperative anxiety, pain and endocrine response. J Int Med Res. 2013 Dec;41(6):1788-95. doi: 10.1177/0300060513500749.

  PMID: 24265330 BACKGROUND

MeSH Terms

Conditions

Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior

Limitations and Caveats

This was a feasibility study that failed to meet its recruitment goals. The results should be viewed with some caution given that the study did not reach its calculated goal sample size.

Results Point of Contact

• Title: Kirsten Tillisch
• Organization: UCLA

ktillisch@mednet.ucla.edu

1 310 208-5400

Study Officials

• Kirsten Tillisch, MD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: devices were masked at supplier and unblinded at end of the study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: May 19, 2016
• First Posted: December 12, 2017
• Study Start: March 1, 2016
• Primary Completion: October 20, 2018
• Study Completion: October 20, 2018
• Last Updated: August 19, 2020
• Results First Posted: August 19, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)