Stress Related DisorderNCT02723188
Modulation of Fear Extinction Processes Using Transcranial Electrical Stimulation
A study testing DC stimulation (1.5 milliampere, 20 minutes) and AC stimulation (1.5 milliampere,1.5 Hertz frequency) in people with Stress Related Disorder and Anxiety, run by Tel Aviv University.
Trial summary
The aim of this study is to examine the effects of transcranial electrical stimulation on processes associated with fear extinction in healthy humans. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Stress Related Disorder, Anxiety
- What is being tested?
- DC stimulation (1.5 milliampere, 20 minutes) and AC stimulation (1.5 milliampere,1.5 Hertz frequency)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- No sites listed yet
- Study dates
- Sep 2014to Apr 2015
- Phase
- Interventional
- 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 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
None listed.
Who cannot join
- Self-reported major psychiatric condition
- Screening specific for electrical stimulation (psychotropic medication, metal implants in head, epilepsy or seizure history)
About this study
The aim of this study is to examine the effects of transcranial electrical stimulation on processes associated with fear extinction in healthy humans.
Read the detailed description
Research links the processes of fear conditioning and extinction to the treatment of anxiety and stress-related disorders. Moreover, considerable translational research examines the neural correlates of these processes. However, virtually no research in humans manipulates neural correlates of these processes, which limits basic-clinical integration. The present study aimed to use transcranial electrical stimulation (tES) to modulate processes associated with fear extinction in order to assess the potential utility of tES in enhancing exposure-based treatment. To this end, healthy participants underwent a three-day fear conditioning and extinction paradigm. Participants were randomly assigned into 3 groups, differing in terms of tES applied during the extinction learning phase (Day 2) and targeting the medial prefrontal cortex: 1) direct current (DC) stimulation, aimed at enhancing extinction learning; 2) alternate current (AC) stimulation, aimed at interfering with reconsolidation of the fear memory activated during the extinction phase; and 3) sham stimulation. The outcome measures (outlined next) involve the assessment of extinction recall during a test phase (Day 3). Successful modulation of extinction learning by tES would be reflected in enhanced extinction recall.
- Conditions
- Stress Related Disorder, Anxiety
- Being tested
- Sham stimulation (1.5 milliampere,30 seconds), DC stimulation (1.5 milliampere, 20 minutes), AC stimulation (1.5 milliampere,1.5 Hertz frequency)
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sham stimulation (1.5 milliampere,30 seconds)Device
Also called DC Stimulator Plus (neuroConn, Germany), serial 0118
DC stimulation (1.5 milliampere, 20 minutes)Device
Also called DC Stimulator Plus (neuroConn, Germany), serial 0118
AC stimulation (1.5 milliampere,1.5 Hertz frequency)Device
Also called DC Stimulator Plus (neuroConn, Germany), serial 0118
| Study group | Role | What they receive |
|---|---|---|
| Sham | Sham comparator | Sham electrical stimulation Receives: Device: Sham stimulation (1.5 milliampere,30 seconds) |
| DC: Direct current | Experimental | Direct current electrical stimulation Receives: Device: DC stimulation (1.5 milliampere, 20 minutes) |
| AC: Alternating current | Experimental | Alternating current electrical stimulation Receives: Device: AC stimulation (1.5 milliampere,1.5 Hertz frequency) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Galvanic Skin Response (GSR)
GSR was measured throughout the task using 2 standard electrodes on the fingers. Measurement units were in micro-Siemens; scores were square-root-transformed (a common method in GSR studies). A higher level of GSR in response to stimuli is taken to reflect greater physiological fear response, and thus worse in the context of the relevance of the study conditions to the treatment of anxiety disorders.
Scores were collected in response to presentation of the CS+ (the stimulus conditioned to be associated with an aversive outcome) and the CS- (the stimulus not conditioned to be associated with any outcome).
Measured: During three-day experimental task
Secondary outcomes (1)
Self-reported Fear Rankings
Participants marked how fearful they are of stimuli used in the task on a single 10-point scale (1=not afraid, 10=extremely afraid). Higher scores therefore reflect greater fear and are worse in the context of treatment for anxiety disorders.
Scores were collected in response to presentation of the CS+ (the stimulus conditioned to be associated with an aversive outcome) and the CS- (the stimulus not conditioned to be associated with any outcome).
Measured: During three-day experimental task
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2016 (estimated)
- Study startSep 2014
- Primary completionApr 2015
- Study completionApr 2015
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Stress Related 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tel Aviv University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yair Bar-Haim, Tel Aviv University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02723188
- Sponsor's protocol ID
- TASMC-13-TH-334
- Status last verified
- May 2017
- First submitted
- 24 Mar 2016
- Last updated
- 14 Jun 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Abend R, Jalon I, Gurevitch G, Sar-El R, Shechner T, Pine DS, Hendler T, Bar-Haim Y. Modulation of fear extinction processes using transcranial electrical stimulation. Transl Psychiatry. 2016 Oct 11;6(10):e913. doi: 10.1038/tp.2016.197.
PubMed 27727241
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modulation of Fear Extinction Processes Using Transcranial Electrical Stimulation
- ClinicalTrials.gov ID
- NCT02723188
- Acronym / sponsor ID
- TASMC-13-TH-334
- Conditions
- Stress Related Disorder, Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Tel Aviv UniversityUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 30 Mar 2016 (estimated)
- Results
- Posted 14 Jun 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to examine the effects of transcranial electrical stimulation on processes associated with fear extinction in healthy humans.
Detailed description
Research links the processes of fear conditioning and extinction to the treatment of anxiety and stress-related disorders. Moreover, considerable translational research examines the neural correlates of these processes. However, virtually no research in humans manipulates neural correlates of these processes, which limits basic-clinical integration. The present study aimed to use transcranial electrical stimulation (tES) to modulate processes associated with fear extinction in order to assess the potential utility of tES in enhancing exposure-based treatment. To this end, healthy participants underwent a three-day fear conditioning and extinction paradigm. Participants were randomly assigned into 3 groups, differing in terms of tES applied during the extinction learning phase (Day 2) and targeting the medial prefrontal cortex: 1) direct current (DC) stimulation, aimed at enhancing extinction learning; 2) alternate current (AC) stimulation, aimed at interfering with reconsolidation of the fear memory activated during the extinction phase; and 3) sham stimulation. The outcome measures (outlined next) involve the assessment of extinction recall during a test phase (Day 3). Successful modulation of extinction learning by tES would be reflected in enhanced extinction recall.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Sham | Sham comparator | Device: Sham stimulation (1.5 milliampere,30 seconds)Sham electrical stimulation |
| DC: Direct current | Experimental | Device: DC stimulation (1.5 milliampere, 20 minutes)Direct current electrical stimulation |
| AC: Alternating current | Experimental | Device: AC stimulation (1.5 milliampere,1.5 Hertz frequency)Alternating current electrical stimulation |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (2 listed)
- Self-reported major psychiatric condition
- Screening specific for electrical stimulation (psychotropic medication, metal implants in head, epilepsy or seizure history)
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 |
|---|---|---|
| Sham stimulation (1.5 milliampere,30 seconds)Also: DC Stimulator Plus (neuroConn, Germany), serial 0118 | Device | Sham |
| DC stimulation (1.5 milliampere, 20 minutes)Also: DC Stimulator Plus (neuroConn, Germany), serial 0118 | Device | DC: Direct current |
| AC stimulation (1.5 milliampere,1.5 Hertz frequency)Also: DC Stimulator Plus (neuroConn, Germany), serial 0118 | Device | AC: Alternating current |
Primary outcome
Galvanic Skin Response (GSR)
Time frame: During three-day experimental task
GSR was measured throughout the task using 2 standard electrodes on the fingers. Measurement units were in micro-Siemens; scores were square-root-transformed (a common method in GSR studies). A higher level of GSR in response to stimuli is taken to reflect greater physiological fear response, and thus worse in the context of the relevance of the study conditions to the treatment of anxiety disorders. Scores were collected in response to presentation of the CS+ (the stimulus conditioned to be associated with an aversive outcome) and the CS- (the stimulus not conditioned to be associated with any outcome).
1 secondary outcome
Self-reported Fear Rankings
Time frame: During three-day experimental task
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 27727241Abend R, Jalon I, Gurevitch G, Sar-El R, Shechner T, Pine DS, Hendler T, Bar-Haim Y. Modulation of fear extinction processes using transcranial electrical stimulation. Transl Psychiatry. 2016 Oct 11;6(10):e913. doi: 10.1038/tp.2016.197.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing DC stimulation (1.5 milliampere, 20 minutes) and AC stimulation (1.5 milliampere,1.5 Hertz frequency) in people with Stress Related Disorder and Anxiety, run by Tel Aviv University.
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 0 inclusion and 2 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 14 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Yes. Results are posted in the registry (first posted 14 Jun 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?
Galvanic Skin Response (GSR) (time frame: During three-day experimental task). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02723188, which also lists 1 linked publication.
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 14 Jun 2017.