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CES for the Treatment of GAD in Young Adults

Sponsor
Electromedical Products International, Inc. (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT06124014
Collaborator
University of North Carolina, Chapel Hill (Other)
130
Enrollment
1
Location
2
Arms
27
Anticipated Duration (Months)
4.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this research study is to study cranial electrotherapy stimulation (CES) to determine its effects on symptoms of anxiety in people with generalized anxiety disorder (GAD) between the ages of 18 - 21 years of age.

Condition or Disease Intervention/Treatment Phase
  • Device: At-Home Stimulation
 N/A

Detailed Description

This study examines (1) the efficacy of CES with the Alpha-Stim AID ® for the treatment of GAD in young adults (18-21 years of age) in a double-blind, sham-controlled parallel group single-site clinical trial of 130 participants.

Participants will be randomized into receiving either active CES (at least 200uA, up to 500uA at 0.5Hz, 60 minutes daily for six weeks) or sham CES with the Alpha-Stim AID ® device at-home. Clinical assessments of anxiety symptoms are performed at Screening (for eligibility), Baseline, Follow-Up 1 (at completion of intervention, 6 weeks after initial stimulation), and Follow-Up 2 (12 weeks after initial stimulation). Additional assessments of depression symptoms and quality of life are included. Resting-state EEG will be collected at baseline and Follow-Up 1 (in up to 60 participants) for exploratory investigation of mechanism of action.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
130 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Treatment
Official Title:
Cranial Electrotherapy Stimulation (CES) for the Treatment of Generalized Anxiety Disorder (GAD) in Young Adults: Double-Blind Sham-Controlled Randomized Clinical Trial
Anticipated Study Start Date :
Dec 1, 2023
Anticipated Primary Completion Date :
Sep 1, 2025
Anticipated Study Completion Date :
Mar 1, 2026

Arms and Interventions

Arm Intervention/Treatment
Experimental: Cranial Electrotherapy Stimulation (CES)

Alpha-Stim AID ® is an FDA-cleared device for the treatment of anxiety that delivers CES through two earclip electrodes.

Device: At-Home Stimulation
The stimulation paradigm in this trial consists of six weeks of daily, 60-minute at-home stimulation sessions.
Sham Comparator: Sham Cranial Electrotherapy Stimulation (CES)

The device for sham stimulation is physically identical and delivers a non-therapeutic dose of stimulation to replicate salient features of device usage.

Device: At-Home Stimulation
The stimulation paradigm in this trial consists of six weeks of daily, 60-minute at-home stimulation sessions.

Outcome Measures

Primary Outcome Measures

  1. Hamilton Anxiety Rating Scale (HAM-A) change [42 days]

    Change in HAM-A between six-week follow-up (FU1) and baseline (D1); minimum value is 0, maximum value is 56. Higher scores indicate worse outcome.

Secondary Outcome Measures

  1. Hamilton Anxiety Rating Scale (HAM-A) change [84 days]

    Change in HAM-A between twelve-week follow-up (FU2) and D1; minimum value is 0, maximum value is 56. Higher scores indicate worse outcome.

  2. Beck Anxiety Inventory (BAI) Change [42 days]

    Change in BAI between FU1 and D1; minimum value is 0, maximum value is 63. Higher scores indicate worse outcome.

  3. Beck Anxiety Inventory (BAI) Change [84 days]

    Change in BAI between FU2 and D1; minimum value is 0, maximum value is 63. Higher scores indicate worse outcome.

  4. Generalized-Anxiety Disorder 7-item (GAD-7) Change [42 days]

    Change in GAD-7 between FU1 and D1; minimum value is 0, maximum value is 21. Higher scores indicate worse outcome.

  5. Generalized-Anxiety Disorder 7-item (GAD-7) Change [84 days]

    Change in GAD-7 between FU2 and baseline D1; minimum value is 0, maximum value is 21. Higher scores indicate worse outcome.

  6. Response/Remission of anxiety [42 days]

    Response/remission rates based on HAM-A scores from FU1 versus baseline D1

  7. Response/Remission of anxiety [84 days]

    Response/remission rates based on HAM-A scores from FU2 versus baseline D1

  8. Change in Clinical Global Impression Scale (CGI) [42 days]

    Change in CGI from FU1 to D1; 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.

  9. Change in Clinical Global Impression Scale (CGI) [84 days]

    Change in CGI from FU2 to baseline D1; 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.

  10. Change in Quality of Life Enjoyment and Satisfaction Questionnaire, short form (Q-LES-Q-SF) [42 days]

    Change in Q-LES-Q-SF from FU1 to D1; minimum value is 14, maximum value is 70. Higher scores indicate better outcome.

  11. Change in Quality of Life Enjoyment and Satisfaction Questionnaire, short form (Q-LES-Q-SF) [84 days]

    Change in Q-LES-Q-SF from FU2 to D1; minimum value is 14, maximum value is 70. Higher scores indicate better outcome.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 21 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • Capable of signing informed consent form.

  • Stated willingness to comply with all study procedures and availability for the duration of the study including refraining from changes to treatment unless medically indicated and communicated to the study team.

  • Aged 18 - 21 at time of screening visit.

  • Diagnosis of generalized anxiety disorder (GAD).

  • At least mild-to-moderate symptom severity, as indicated by scores of 15 or higher on the clinician-administered HAM-A at the screening visit.

  • Concurrent psychiatric medications are allowed. Participants will be required to maintain a sable dose of medications, or remain medication free, for 2 weeks prior to the screening visit, except for antidepressants for which the period of stable dose is 4 weeks prior to screening visit. Concurrent psychotherapy is allowed.

  • People of reproductive potential must be willing to use effective contraception (evidence-based hormonal or barrier methods) for at least 1 month prior to the screening visit and agree to use such a method during study participation.

Exclusion Criteria:

Time-frames are determined relative to the screening visit.

  • Current (any) or previous (> 7 stimulation sessions in last 6 weeks) use of a CES device.

  • Inability to tolerate the required minimum stimulation amplitude (200 uA) during the initial device training at the baseline visit.

  • Experimental or clinical brain stimulation such as deep brain stimulation or transcranial magnetic stimulation for any indication (current or within 60 days prior to screening visit).

  • Implanted medical device that uses electricity anywhere in the body.

  • Diagnosis (based on MINI) of bipolar I or II (past or current), moderate or severe alcohol use disorder (within 12 months prior to screening visit), moderate or severe (non-alcohol) substance use disorder (within 12 months prior to screening visit), psychotic disorder (current or lifetime), major depressive disorder with psychotic features, bipolar I with psychotic features, anorexia nervosa.

  • Epilepsy (current or history). History of febrile childhood seizures and non-epileptic seizures are allowed.

  • Pregnant or breast-feeding.

  • Enrollment in clinical trial for any condition (current or within 60 days prior to screening visit).

  • Hospitalization for any reason (current or past 2 weeks).

  • Self-harming behaviors (current or within two years prior to screening visit).

  • Higher than low suicide risk on the Columbia Suicide Severity Rating Scale (C-SSRS).

  • Known cardiac abnormality or clinically significant heart disease.

  • Anything that would make participation in the study unsafe or medically unadvisable in the assessment of a study clinician.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Carolina Center for Neurostimulation Chapel Hill North Carolina United States 27516

Sponsors and Collaborators

  • Electromedical Products International, Inc.
  • University of North Carolina, Chapel Hill

Investigators

  • Principal Investigator: Samantha Meltzer-Brody, MD, University of North Carolina, Chapel Hill

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

Responsible Party:
Electromedical Products International, Inc.
ClinicalTrials.gov Identifier:
NCT06124014
Other Study ID Numbers:
  • 24-0524
First Posted:
Nov 9, 2023
Last Update Posted:
Nov 9, 2023
Last Verified:
Nov 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Product Manufactured in and Exported from the U.S.:
No
Keywords provided by Electromedical Products International, Inc.
CES
Additional relevant MeSH terms:
Anxiety Disorders

Study Results

No Results Posted as of Nov 9, 2023