AnxietyPhase 4NCT00928772
Cranial Electro Therapy Stimulation in Reducing Perioperative Anxiety
A Phase 4 study of Anxiety, run by University of Oklahoma at 1 site in United States.
Trial summary
Cranial electro stimulation (CES) provides safe, adequate, side-effect free sedation without excessive drowsiness in preoperative settings. Read more about this study
- Who is it for?
- Ages 50 to 90 years
- Conditions the study is for
- Anxiety
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 115 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2009to Feb 2012
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 50 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients of both genders between 50 and 90 years old scheduled for an outpatient "first eye" cataract phacoemulsification with topical anesthesia.
- ASA classification I II and III
Who cannot join
- ASA classification IV (patients with a chronic or severe disease).
- Hypersensitivity to midazolam or benzodiazepines
- acute narrow-angle glaucoma
- untreated open-angle glaucoma
- Patients with any sort of psychiatric or neurological disorder
- Patients on anti-anxiety medication
- Patients who have demand-type pacemakers installed before 1999* *Note: These are the exclusions listed for liability purposes by Alpha-Stim. There are no FDA exclusions.
Trial locations and contacts
1 site in 1 country.
United States1 site
Oklahoma City VA Medical Center
Oklahoma City, Oklahoma, 73104
About this study
Official title: The Effect of Cranial Electro Therapy Stimulation in Reducing Perioperative Anxiety for Patients Undergoing First Eye Cataract Surgery
Cranial electro stimulation (CES) provides safe, adequate, side-effect free sedation without excessive drowsiness in preoperative settings.
Read the detailed description
CES Alpha-Stim is a non-invasive device which has been in place and has been approved for patients to reduce anxiety by the FDA. This study involves the use of CES Alpha-Stim device applied to the patient 30 minutes before and through-out cataract surgery procedure and then to measure the level of anxiety and discomfort by using a visual analog scale (VAS). We propose that by applying the device the patients will be able to have markedly less level of anxiety and discomfort before and during the surgery and will ultimately avoid the traditional use of sedative or analgesic drugs being used for these kinds of surgery.
- Conditions
- Anxiety
- Being tested
- CRANIAL ELECTROTHERAPY (Alpha Stim) + SHAM MIDAZOLAM, MIDAZOLAM + SHAM ELECTRODES SIMULATING CRANIAL ELECTROTHERAPY, NO SEDATION WITH SHAM CRANIAL ELECTROSTIMULATION AND PLACEBO VERSED
- Keywords
- Cranial Electro Stimulation, First Eye Cataract Surgery, Preoperative sedation, Perioperative sedation
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CRANIAL ELECTROTHERAPY (Alpha Stim) + SHAM MIDAZOLAMDevice
Also called AlphaStim
APPLYING OF ELECTRODES ON THE EAR LOBES AND TEMPLES WHICH ARE SENDING AN ACTIVE MICROCURRENT THROUGH THE MIDBRAIN PRODUCING SEDATION WITHOUT PHARMACOLOGICAL AGENTS AND GIVING NORMAL SALINE AS A SHAM DRUG SEDATION
MIDAZOLAM + SHAM ELECTRODES SIMULATING CRANIAL ELECTROTHERAPYDrug
Also called VERSED
CONVENTIONAL METHOD OF PERIOPERATIVE SEDATION
NO SEDATION WITH SHAM CRANIAL ELECTROSTIMULATION AND PLACEBO VERSEDOther
NO ACTIVE SEDATION, ONLY SHAM ELECTRODES AND NORMAL SALINE SIMULATING MIDAZOLAM.
| Study group | Role | What they receive |
|---|---|---|
| Alpha-Stim intervention | Active comparator | One hour Alpha-Stim intervention with sham midazolam Receives: Device: CRANIAL ELECTROTHERAPY (Alpha Stim) + SHAM MIDAZOLAM |
| Sham Alpha-Stim with midazolam | Sham comparator | Sham Alpha-Stim intervention with real midazolam administration Receives: Drug: MIDAZOLAM + SHAM ELECTRODES SIMULATING CRANIAL ELECTROTHERAPY |
| Placebo | Placebo comparator | No Alpha-Stim and only topical anesthetics Receives: Other: NO SEDATION WITH SHAM CRANIAL ELECTROSTIMULATION AND PLACEBO VERSED |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety During Cataract Surgery Under Topical Anesthesia
Anxiety was accessed via VAS from 0 to 10 with 10 being the most anxious.
Measured: during the cataract surgery up to30 minutes
Secondary outcomes (3)
Eye Discomfort Perception During Cataract Surgery Under Topical Anesthesia
VAS from 0 to 10 with 10 being maximal discomfort percieved
Measured: during cataract surgery up to 30 minutes
Mean Arterial Pressure During the Cataract Surgery Under Topical Anesthesia
Measured: during cataract surgery up to 30 minutes
Heart Rate During Cataract Surgery Under Topical Anesthesia
Measured: during cataract surgery up to 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2009 (estimated)
- Study startJul 2009
- Primary completionFeb 2012
- Study completionFeb 2012
Why it stopped: Lack of efficacy
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AnxietyStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 115 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oklahoma
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Grigory Chernyak, Principal investigator, Oklahoma City VAMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00928772
- Sponsor's protocol ID
- 14694
- Status last verified
- Apr 2017
- First submitted
- 25 Jun 2009
- Last updated
- 20 Apr 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Cranial Electro Therapy Stimulation in Reducing Perioperative Anxiety for Patients Undergoing First Eye Cataract Surgery
- ClinicalTrials.gov ID
- NCT00928772
- Acronym / sponsor ID
- 14694
- Conditions
- Anxiety
- Keywords
- Cranial Electro Stimulation, First Eye Cataract Surgery, Preoperative sedation, Perioperative sedation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of efficacy
- Enrolment
- 115 participants (actual)
- Lead sponsor
- University of OklahomaUniversity, hospital or other
- Study start
- Jul 2009
- Primary completion
- Feb 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 26 Jun 2009 (estimated)
- Results
- Posted 20 Apr 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Cranial electro stimulation (CES) provides safe, adequate, side-effect free sedation without excessive drowsiness in preoperative settings.
Detailed description
CES Alpha-Stim is a non-invasive device which has been in place and has been approved for patients to reduce anxiety by the FDA. This study involves the use of CES Alpha-Stim device applied to the patient 30 minutes before and through-out cataract surgery procedure and then to measure the level of anxiety and discomfort by using a visual analog scale (VAS). We propose that by applying the device the patients will be able to have markedly less level of anxiety and discomfort before and during the surgery and will ultimately avoid the traditional use of sedative or analgesic drugs being used for these kinds of surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Alpha-Stim intervention | Active comparator | Device: CRANIAL ELECTROTHERAPY (Alpha Stim) + SHAM MIDAZOLAMOne hour Alpha-Stim intervention with sham midazolam |
| Sham Alpha-Stim with midazolam | Sham comparator | Drug: MIDAZOLAM + SHAM ELECTRODES SIMULATING CRANIAL ELECTROTHERAPYSham Alpha-Stim intervention with real midazolam administration |
| Placebo | Placebo comparator | Other: NO SEDATION WITH SHAM CRANIAL ELECTROSTIMULATION AND PLACEBO VERSEDNo Alpha-Stim and only topical anesthetics |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients of both genders between 50 and 90 years old scheduled for an outpatient "first eye" cataract phacoemulsification with topical anesthesia.
- ASA classification I II and III
Key exclusion criteria (7 listed)
- ASA classification IV (patients with a chronic or severe disease).
- Hypersensitivity to midazolam or benzodiazepines
- acute narrow-angle glaucoma
- untreated open-angle glaucoma
- Patients with any sort of psychiatric or neurological disorder
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 |
|---|---|---|
| CRANIAL ELECTROTHERAPY (Alpha Stim) + SHAM MIDAZOLAMAlso: AlphaStimAPPLYING OF ELECTRODES ON THE EAR LOBES AND TEMPLES WHICH ARE SENDING AN ACTIVE MICROCURRENT THROUGH THE MIDBRAIN PRODUCING SEDATION WITHOUT PHARMACOLOGICAL AGENTS AND GIVING NORMAL SALINE AS A SHAM DRUG SEDATION | Device | Alpha-Stim intervention |
| MIDAZOLAM + SHAM ELECTRODES SIMULATING CRANIAL ELECTROTHERAPYAlso: VERSEDCONVENTIONAL METHOD OF PERIOPERATIVE SEDATION | Drug | Sham Alpha-Stim with midazolam |
| NO SEDATION WITH SHAM CRANIAL ELECTROSTIMULATION AND PLACEBO VERSEDNO ACTIVE SEDATION, ONLY SHAM ELECTRODES AND NORMAL SALINE SIMULATING MIDAZOLAM. | Other | Placebo |
Primary outcome
Anxiety During Cataract Surgery Under Topical Anesthesia
Time frame: during the cataract surgery up to30 minutes
Anxiety was accessed via VAS from 0 to 10 with 10 being the most anxious.
3 secondary outcomes
Eye Discomfort Perception During Cataract Surgery Under Topical Anesthesia
Time frame: during cataract surgery up to 30 minutes
Mean Arterial Pressure During the Cataract Surgery Under Topical Anesthesia
Time frame: during cataract surgery up to 30 minutes
Heart Rate During Cataract Surgery Under Topical Anesthesia
Time frame: during cataract surgery up to 30 minutes
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Anxiety
Not yet recruiting
Building Resilience Through Anxiety Virtual Education in PICU Survivors
Critical Illness Recovery, Mental Health
Not yet recruiting
Mandala Coloring in Late Pregnancy
Pregnancy, Anxiety
Recruiting
Modulating Escape Using Focused Ultrasound
Anxiety Disorders
Not yet recruitingObservational study
Ecological Momentary Assessment of State-Dependent Decision-Making and Metacognition Across a Psychopathology Continuum
Depression, Anxiety
Recruiting
Stress and Anxiety Effects on Valuation
Reward Value Level
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.
Grigory Chernyak principal investigator
Oklahoma City VAMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study of Anxiety, run by University of Oklahoma 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 2 inclusion and 7 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: stopped early, as of the sponsor's last update on 20 Apr 2017. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Apr 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Anxiety During Cataract Surgery Under Topical Anesthesia (time frame: during the cataract surgery up to30 minutes). 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 20 Apr 2017.