PTSD, Post Traumatic Stress DisorderCESNCT03757494
Cranial Electrotherapy Stimulation in the Treatment of Posttraumatic Stress Disorder
A study testing Alpha Stim in people with PTSD, Post Traumatic Stress Disorder, run by White River Junction Veterans Affairs Medical Center at 1 site in United States.
Trial summary
This is a research study that will look at how well a treatment called Cranial Electrotherapy Stimulation (CES) works for patients who struggle with symptoms of Posttraumatic Stress Disorder. Cranial Electrotherapy Stimulation is delivered using a device called Alpha-Stim®. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- PTSD, Post Traumatic Stress Disorder
- What is being tested?
- Alpha Stim
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Oct 2018to 21 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- To ensure participants can safely receive Alpha-Stim®, eligible participants must meet all established screening criteria for safety during Alpha-Stim® using a safety screener (as assessed during phone screen and medical records review). We are screening to access for metal. These are conservative measures require a patient not having the following (unless MRI-safe): Cardiac pacemaker, implanted device (deep brain stimulation) or metal in the brain, cervical spinal cord, or upper thoracic spinal cord. The patient would additionally be required to not have an implanted cardiac defibrillator;
- Outpatients 18-70 years of age (inclusive);
- Meet DSM-V criteria for PTSD (acute or chronic) at the time of the screening and/or baseline visit; symptoms.
- Have a baseline score of "Moderately Ill" or worse on the CGI-S;
- Be on a stable psychotropic regimen for at least 6 weeks prior to baseline, or no psychotropic medication at all (for at least 6 weeks prior to baseline), and be willing to maintain the current regimen and dosing for the duration of the study (unless medically necessary to make changes with notification of research staff);
- If female and of child bearing potential, agree to use an acceptable method of birth control for the duration of the study treatment period; (8) Be willing and able to comply with all study related procedures and visits; (9) Be capable of independently reading and understanding patient information materials and giving written informed consent.
- -
Who cannot join
- Participants will be excluded from participation if they meet any of the following:
- Are pregnant or lactating or planning to become pregnant within the next three months;
- Have a lifetime history of loss of consciousness due to head injury for greater than 10 minutes, or any lifetime history of loss of consciousness due to a head injury with documented evidence of brain injury (including brain atrophy);
- Current (or past if appropriate) significant neurological disorder, or lifetime history of a) seizure disorder b) primary or secondary CNS tumors c) stroke or d) cerebral aneurysm;
- Unstable medical illness, or, in the opinion of the investigator, significant absence of appropriate medical care;
- Current Axis 1 primary psychotic disorder, or bipolar I disorder, active moderate/severe substance use disorders (within the last month as assessed by review of the medical records and veteran self-report, excluding nicotine/caffeine). Veterans on stable (>3 months), monitored opiate agonist therapy may be included at the investigator's discretion;
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- Past failed treatment with rTMS or ECT; any past treatment with deep brain stimulation or vagus nerve stimulation;
- Have active suicidal intent or plan as detected on screening assessments, or in the Investigator's opinion, is likely to attempt suicide within the next six months;
- Mental retardation or cognitive impairment
- History of stroke, Parkinson's Disease, Multiple Sclerosis, or seizures
- Current use of Transcutaneous electrical nerve stimulation (TENS) unit
- Previous history of Alpha-Stim® use
- Inability to read and write in English
- Incapacity to make informed medical decisions for any reason
- Pregnancy: Pregnant women are not eligible for the study. Women with potential for pregnancy will receive a pregnancy test provided by the VA prior to the study. Women of childbearing capacity are eligible for the study. Contraceptive plans will be discussed and if they are determined to be inadequate, the participant will be excluded from the study.
- Presence of an implanted defibrillator or pacemaker device.
- Demonstrate the presence of any other condition or circumstance that, in the opinion of the investigator, has the potential to prevent study completion and/or to have a confounding effect on outcome assessments.
- -
Trial locations and contacts
1 site in 1 country.
United States1 site
White River Junction VAMC
White River Junction, Vermont, 05009
About this study
Official title: Cranial Electrotherapy Stimulation in the Treatment of Posttraumatic Stress Disorder: A Feasibility, Safety and Efficacy Study
This is a research study that will look at how well a treatment called Cranial Electrotherapy Stimulation (CES) works for patients who struggle with symptoms of Posttraumatic Stress Disorder. Cranial Electrotherapy Stimulation is delivered using a device called Alpha-Stim®. This is a safe, non-invasive treatment that applies a low-level pulsed electric current through the brain using clip-on electrodes attached to the earlobes. Cranial Electrotherapy Stimulation treats conditions such as physical pain, anxiety, and depression.
- Conditions
- PTSD, Post Traumatic Stress Disorder
- Being tested
- Alpha Stim
- Medical subject headings
- Combat Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alpha StimDevice
Use of Alpha Stim Device
| Study group | Role | What they receive |
|---|---|---|
| Use of Alpha Stim | Experimental | Use of Alpha Stim Device Receives: Device: Alpha Stim |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of Alpha-Stim® Cranial Electrotherapy Stimulation (CES) as a treatment for Posttraumatic Stress Disorder (PTSD).
We will deem the treatment feasible if ≥ 6 participants complete the protocol, based on completion of ≥ 60% treatments (3 out of 5 treatment days, weekly at home), and attending and completing ≥ 75% of the weekly assessments, including the week 1 baseline and week 4 treatment completion visit
Measured: 1 year
Secondary outcomes (1)
Safety of the Alpha-Stim® Cranial Electrotherapy Stimulation (CES) as a treatment for Posttraumatic Stress Disorder.
Safety and tolerability, we expect this treatment to be safe, based on the very few adverse events and no serious adverse events in the literature and relative safety when compared to current pharmacologic treatments (e.g., SSRIs and SNRIs) for PTSD.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2018
- Study start18 Oct 2018
- Primary completion21 Sep 2022
- Study completion21 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PTSD, Post Traumatic Stress DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Using Alpha Stim
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- White River Junction Veterans Affairs Medical Center
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, James Rustad, White River Junction Veterans Affairs Medical Center
- Investigators
- James K Rustad, MD, Principal investigator, White River Junction Veterans Affairs Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03757494
- Sponsor's protocol ID
- 1286051
- Acronym
- CES
- Status last verified
- Jan 2023
- First submitted
- 17 Oct 2018
- Last updated
- 31 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cranial Electrotherapy Stimulation in the Treatment of Posttraumatic Stress Disorder: A Feasibility, Safety and Efficacy Study
- ClinicalTrials.gov ID
- NCT03757494
- Acronym / sponsor ID
- CES / 1286051
- Conditions
- PTSD, Post Traumatic Stress Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- White River Junction Veterans Affairs Medical CenterUS federal agency
- Study start
- 18 Oct 2018 (actual)
- Primary completion
- 21 Sep 2022 (actual)
- Study completion
- 21 Sep 2022 (actual)
- First posted
- 29 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a research study that will look at how well a treatment called Cranial Electrotherapy Stimulation (CES) works for patients who struggle with symptoms of Posttraumatic Stress Disorder. Cranial Electrotherapy Stimulation is delivered using a device called Alpha-Stim®. This is a safe, non-invasive treatment that applies a low-level pulsed electric current through the brain using clip-on electrodes attached to the earlobes. Cranial Electrotherapy Stimulation treats conditions such as physical pain, anxiety, and depression.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Using Alpha Stim
| Arm | Type | Receives |
|---|---|---|
| Use of Alpha Stim | Experimental | Device: Alpha StimUse of Alpha Stim Device |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- To ensure participants can safely receive Alpha-Stim®, eligible participants must meet all established screening criteria for safety during Alpha-Stim® using a safety screener (as assessed during phone screen and medical records review). We are screening to access for metal. These are conservative measures require a patient not having the following (unless MRI-safe): Cardiac pacemaker, implanted device (deep brain stimulation) or metal in the brain, cervical spinal cord, or upper thoracic spinal cord. The patient would additionally be required to not have an implanted cardiac defibrillator;
- Outpatients 18-70 years of age (inclusive);
- Meet DSM-V criteria for PTSD (acute or chronic) at the time of the screening and/or baseline visit; symptoms.
- Have a baseline score of "Moderately Ill" or worse on the CGI-S;
- Be on a stable psychotropic regimen for at least 6 weeks prior to baseline, or no psychotropic medication at all (for at least 6 weeks prior to baseline), and be willing to maintain the current regimen and dosing for the duration of the study (unless medically necessary to make changes with notification of research staff);
Key exclusion criteria (18 listed)
- Are pregnant or lactating or planning to become pregnant within the next three months;
- Have a lifetime history of loss of consciousness due to head injury for greater than 10 minutes, or any lifetime history of loss of consciousness due to a head injury with documented evidence of brain injury (including brain atrophy);
- Current (or past if appropriate) significant neurological disorder, or lifetime history of a) seizure disorder b) primary or secondary CNS tumors c) stroke or d) cerebral aneurysm;
- Unstable medical illness, or, in the opinion of the investigator, significant absence of appropriate medical care;
- Current Axis 1 primary psychotic disorder, or bipolar I disorder, active moderate/severe substance use disorders (within the last month as assessed by review of the medical records and veteran self-report, excluding nicotine/caffeine). Veterans on stable (>3 months), monitored opiate agonist therapy may be included at the investigator's discretion;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Alpha StimUse of Alpha Stim Device | Device | Use of Alpha Stim |
Primary outcome
Feasibility of Alpha-Stim® Cranial Electrotherapy Stimulation (CES) as a treatment for Posttraumatic Stress Disorder (PTSD).
Time frame: 1 year
We will deem the treatment feasible if ≥ 6 participants complete the protocol, based on completion of ≥ 60% treatments (3 out of 5 treatment days, weekly at home), and attending and completing ≥ 75% of the weekly assessments, including the week 1 baseline and week 4 treatment completion visit
1 secondary outcome
Safety of the Alpha-Stim® Cranial Electrotherapy Stimulation (CES) as a treatment for Posttraumatic Stress Disorder.
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James K Rustad, MD principal investigator
White River Junction Veterans Affairs Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Alpha Stim in people with PTSD, Post Traumatic Stress Disorder, run by White River Junction Veterans Affairs Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of Alpha-Stim® Cranial Electrotherapy Stimulation (CES) as a treatment for Posttraumatic Stress Disorder (PTSD). (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2023.