AnxietyNCT04961112
Evaluating the Efficacy of Cranial Electrotherapy Stimulation in Mitigating Anxiety-induced Cognitive Deficits
A study testing Cranial Electrotherapy Stimulation in people with Anxiety and Cognitive Deficit, run by Tufts University at 1 site in United States.
Trial summary
This study investigates the potential of cranial electrotherapy stimulation to mitigate anxiety induced cognitive deficits Read more about this study
- Who is it for?
- Ages 18 to 28 yearsHealthy volunteers can take part
- Conditions the study is for
- Anxiety, Cognitive Deficit
- What is being tested?
- Cranial Electrotherapy Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 124 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Sep 2021to 7 Apr 2025
- 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 28 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Between 18-28 years old
Who cannot join
- History of diagnosis with a neurological or psychiatric disorder.
Trial locations and contacts
1 site in 1 country.
About this study
This study investigates the potential of cranial electrotherapy stimulation to mitigate anxiety induced cognitive deficits
- Conditions
- Anxiety, Cognitive Deficit
- Being tested
- Cranial Electrotherapy Stimulation, Sham Cranial Electrotherapy Stimulation
- Keywords
- Cranial electrotherapy stimulation, Executive functioning, Induced Anxiety, Cognition, Threat of shock, Heart rate variability
- Medical subject headings
- Anxiety Disorders, Cognition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cranial Electrotherapy StimulationDevice
Also called Transcranial Pulsed Current Stimulation, Cranial Electrical Stimulation
Participants will receive cranial electrotherapy stimulation stimulation on one of two separate visits (within-subjects).
Sham Cranial Electrotherapy StimulationDevice
Participants will receive sham stimulation on one of two separate visits (within-subjects).
| Study group | Role | What they receive |
|---|---|---|
| Experimental - Induced Anxiety | Experimental | Participants will be administered a shock procedure in which they are exposed to safe electrical shock that will be gradually increase from (1) 30 milliseconds to (4) 80 milliseconds to an individual threshold that is uncomfortable but not painful. Participants will be told they may receive additional shocks for poor performance during cognitive assessments.
Participants will be administered cranial electrotherapy stimulation with a frequency of .5 Hz and a current of 100 microamps during 30 minutes of cognitive assessments of task switching, inhibition (stroop), working memory (n-back), and processing speed (simple reaction time). Receives: Device: Cranial Electrotherapy Stimulation |
| Experimental - No Induced Anxiety | Experimental | Participants will be administered a shock procedure in which they are exposed to safe electrical shock that will be gradually increase from (1) 30 milliseconds to (4) 80 milliseconds to an individual threshold that is uncomfortable but not painful. After this procedure, the shock belt will be turned off. Participants will be told they will not receive additional shocks during cognitive assessments.
Participants will be administered cranial electrotherapy stimulation with a frequency of .5 Hz and a current of 100 microamps during 30 minutes of cognitive assessments of task switching, inhibition (stroop), working memory (n-back), and processing speed (simple reaction time). Receives: Device: Cranial Electrotherapy Stimulation |
| Sham - Induced Anxiety | Sham comparator | Participants will be administered a shock procedure in which they are exposed to safe electrical shock that will be gradually increase from (1) 30 milliseconds to (4) 80 milliseconds to an individual threshold that is uncomfortable but not painful. Participants will be told they may receive additional shocks for poor performance during cognitive assessments.
Participants will be administered sham cranial electrotherapy stimulation with no current during 30 minutes of cognitive assessments of task switching, inhibition (stroop), working memory (n-back), and processing speed (simple reaction time). Receives: Device: Sham Cranial Electrotherapy Stimulation |
| Sham - No Induced Anxiety | Sham comparator | Participants will be administered a shock procedure in which they are exposed to safe electrical shock that will be gradually increase from (1) 30 milliseconds to (4) 80 milliseconds to an individual threshold that is uncomfortable but not painful. After this procedure, the shock belt will be turned off. Participants will be told they will not receive additional shocks during cognitive assessments.
Participants will be administered sham cranial electrotherapy stimulation with no current during 30 minutes of cognitive assessments of task switching, inhibition (stroop), working memory (n-back), and processing speed (simple reaction time). Receives: Device: Sham Cranial Electrotherapy Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Task switching
Switch cost (mean switch reaction time- mean stay reaction time)
Measured: 68 weeks
Working memory (N-back)
2-back condition mean accuracy
Measured: 68 weeks
Inhibition (Stroop)
Stroop interference cost (mean incongruent reaction time- mean congruent reaction time)
Measured: 68 weeks
Processing speed (Simple reaction time task)
Mean reaction time
Measured: 68 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2021
- Study start6 Sep 2021
- Primary completion7 Apr 2025
- Study completion7 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tufts University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nathan Ward, Tufts University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04961112
- Sponsor's protocol ID
- 1908026
- Status last verified
- Apr 2025
- First submitted
- 1 Jul 2021
- Last updated
- 10 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Efficacy of Cranial Electrotherapy Stimulation in Mitigating Anxiety-induced Cognitive Deficits
- ClinicalTrials.gov ID
- NCT04961112
- Acronym / sponsor ID
- 1908026
- Conditions
- Anxiety, Cognitive Deficit
- Keywords
- Cranial electrotherapy stimulation, Executive functioning, Induced Anxiety, Cognition, Threat of shock, Heart rate variability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- Tufts UniversityUniversity, hospital or other
- Study start
- 6 Sep 2021 (actual)
- Primary completion
- 7 Apr 2025 (actual)
- Study completion
- 7 Apr 2025 (actual)
- First posted
- 14 Jul 2021 (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 study investigates the potential of cranial electrotherapy stimulation to mitigate anxiety induced cognitive deficits
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Experimental - Induced Anxiety | Experimental | Device: Cranial Electrotherapy StimulationParticipants will be administered a shock procedure in which they are exposed to safe electrical shock that will be gradually increase from (1) 30 milliseconds to (4) 80 milliseconds to an individual threshold that is uncomfortable but not painful. Participants will be told they may receive additional shocks for poor performance during cognitive assessments. Participants will be administered cranial electrotherapy stimulation with a frequency of .5 Hz and a current of 100 microamps during 30 minutes of cognitive assessments of task switching, inhibition (stroop), working memory (n-back), and processing speed (simple reaction time). |
| Experimental - No Induced Anxiety | Experimental | Device: Cranial Electrotherapy StimulationParticipants will be administered a shock procedure in which they are exposed to safe electrical shock that will be gradually increase from (1) 30 milliseconds to (4) 80 milliseconds to an individual threshold that is uncomfortable but not painful. After this procedure, the shock belt will be turned off. Participants will be told they will not receive additional shocks during cognitive assessments. Participants will be administered cranial electrotherapy stimulation with a frequency of .5 Hz and a current of 100 microamps during 30 minutes of cognitive assessments of task switching, inhibition (stroop), working memory (n-back), and processing speed (simple reaction time). |
| Sham - Induced Anxiety | Sham comparator | Device: Sham Cranial Electrotherapy StimulationParticipants will be administered a shock procedure in which they are exposed to safe electrical shock that will be gradually increase from (1) 30 milliseconds to (4) 80 milliseconds to an individual threshold that is uncomfortable but not painful. Participants will be told they may receive additional shocks for poor performance during cognitive assessments. Participants will be administered sham cranial electrotherapy stimulation with no current during 30 minutes of cognitive assessments of task switching, inhibition (stroop), working memory (n-back), and processing speed (simple reaction time). |
| Sham - No Induced Anxiety | Sham comparator | Device: Sham Cranial Electrotherapy StimulationParticipants will be administered a shock procedure in which they are exposed to safe electrical shock that will be gradually increase from (1) 30 milliseconds to (4) 80 milliseconds to an individual threshold that is uncomfortable but not painful. After this procedure, the shock belt will be turned off. Participants will be told they will not receive additional shocks during cognitive assessments. Participants will be administered sham cranial electrotherapy stimulation with no current during 30 minutes of cognitive assessments of task switching, inhibition (stroop), working memory (n-back), and processing speed (simple reaction time). |
Who may qualify
- Ages
- 18 to 28 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Between 18-28 years old
Key exclusion criteria (1 listed)
- History of diagnosis with a neurological or psychiatric 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 StimulationAlso: Transcranial Pulsed Current Stimulation, Cranial Electrical StimulationParticipants will receive cranial electrotherapy stimulation stimulation on one of two separate visits (within-subjects). | Device | Experimental - Induced Anxiety, Experimental - No Induced Anxiety |
| Sham Cranial Electrotherapy StimulationParticipants will receive sham stimulation on one of two separate visits (within-subjects). | Device | Sham - Induced Anxiety, Sham - No Induced Anxiety |
Primary outcome
Task switching
Time frame: 68 weeks
Switch cost (mean switch reaction time- mean stay reaction time)
Working memory (N-back)
Time frame: 68 weeks
2-back condition mean accuracy
Inhibition (Stroop)
Time frame: 68 weeks
Stroop interference cost (mean incongruent reaction time- mean congruent reaction time)
Processing speed (Simple reaction time task)
Time frame: 68 weeks
Mean reaction time
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 10 Apr 2025.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cranial Electrotherapy Stimulation in people with Anxiety and Cognitive Deficit, run by Tufts University 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 1 inclusion and 1 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 10 Apr 2025. 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.
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?
Task switching (time frame: 68 weeks). The study lists 4 primary outcomes in all. 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 10 Apr 2025.