Panic DisorderPDStimNCT04160806
The Effect Of Transcranial Direct Current Stimulation In Panic Disorder
A study testing Transcranial direct current stimulation in people with Panic Disorder, run by Istanbul University at 1 site in Turkey (Türkiye).
Trial summary
The aim of the present study is to investigate the effect of prefrontal transcranial Direct Current Stimulation (tDCS) on clinical severity, attentional bias and interoceptive accuracy in panic disorder (PD). The participants will be assigned to active and sham groups (1:1) and will receive 10 sessions of tDCS. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Panic Disorder
- What is being tested?
- Transcranial direct current stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2019to 1 Nov 2021
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients with a primary diagnosis of Panic Disorder, as confirmed by the Structured Clinical Interview for the DSM-5 (SCID-5);
- Patients currently on medication must be at the same stable dose(s) for one month prior to enrollment and be willing to continue at the same dose(s) through the duration of the study;
- Right-hand dominancy assessed by Edinburgh Handedness Inventory;
- Willingness and ability to comply with the requirements of the study protocol;
- Naïve to tDCS.
- 5 or more years of education
Who cannot join
- Illiteracy, deficient language or refusal to participate or being not able to follow instructions or complete study tasks;
- Less than 5 years of education
- Individuals with any current or lifetime diagnosis of other Axis I disorders, as confirmed by the Structured Clinical Interview for the DSM-5 (SCID-5);
- History of substance or psychoactive compound use,with the exception of nicotine consumption;
- The presence of mental retardation diagnosis (previously identified)
- Individuals with a clinically defined neurological disorder, with an increased risk of seizure for any reason, with a history of treatment with rTMS, deep brain stimulation for any disorder will be excluded;
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- Any personal or family history (1st degree relatives) of seizures other than febrile childhood seizures
- Personal history of head trauma that resulted in loss of consciousness for > 5 minutes and retrograde amnesia for > 30 minutes;
- Significant hearing loss or visual impairment;
- Diagnosis of any serious or uncontrolled medical condition such as chronic obstructive pulmonary disease, congestive heart failure or renal failure;
- Skin diseases that could potentially cause irritations under electrodes;
- Patients missing two consecutive protocol sessions;
- Patients with cardiac pacemakers, implanted medication pumps, intracardiac lines, or acute, unstable cardiac disease, with intracranial implants (e.g. aneurysm clips, shunts, stimulators, cochlear implants, or electrodes) or any other metal object within or near the head, excluding the mouth, that cannot be safely removed will be excluded.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Department Of Psychiatry, Istanbul University
Istanbul, 34060
About this study
Official title: The Effect Of Prefrontal Transcranial Direct Current Stimulation On Clinical Severity, Attentional Bias and Interoceptive Accuracy In Panic Disorder
The aim of the present study is to investigate the effect of prefrontal transcranial Direct Current Stimulation (tDCS) on clinical severity, attentional bias and interoceptive accuracy in panic disorder (PD).
The participants will be assigned to active and sham groups (1:1) and will receive 10 sessions of tDCS. The study will also examine if the effects may last for a month.
Read the detailed description
Panic Disorder (PD) is one of the most common anxiety disorders. In spite of several available medications, there are unsatisfactory outcomes in a considerable proportion of PD patients and novel treatment approaches are lacking. Given that response to pharmacotherapeutical and psychological treatments occur after long intervals and medications may cause substantial adverse effects which may affect treatment compliance, fast acting and well-tolerated treatments such as non-invasive brain stimulation are considered to be useful as primary treatment approach or as an add-on treatment in PD. Repetitive Transcranial Magnetic Stimulation (rTMS) trials targeting prefrontal cortex mostly reported favorable outcomes in PD.
Transcranial Direct Current Stimulation (tDCS) is another promising non-invasive brain stimulation method with numerous distinctive aspects including its low-cost, robust safety and tolerability, low dropout rates, easy application, reliable blinding procedures and the opportunity to use concomitantly with other treatments. Left anodal/right anodal tDCS over the dorsolateral prefrontal cortex has been demonstrated to decrease attentional bias and amygdala reactivity to threat in individuals with high trait anxiety. Moreover, a treatment-resistant case of PD was reported to have significant amelioration of symptoms up to one month after 10 sessions of tDCS.
The study is a triple-blind randomized controlled trial. The sample will be consisted of thirty participants diagnosed as having PD due to Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria. The participants will be assigned to active or sham groups equally. Clinical severity will be assessed with adequate scales. Emotion recognition, attentional bias to threat and interoceptive accuracy will also be measured. Then, participants will be applied ten active or sham sessions of left anodal/right cathodal tDCS over the dorsolateral prefrontal cortex (DLPFC). All measurements will be repeated after the applications. Succinctly, the aim of this study is to assess the effect of ten sessions left anodal/right cathodal tDCS over the DLPFC on clinical severity, attentional bias and interoceptive accuracy in PD.
- Conditions
- Panic Disorder
- Being tested
- Transcranial direct current stimulation
- Keywords
- Anxiety disorders, Panic disorder, Transcranial Direct Current Stimulation, Interoceptive accuracy, Attention bias, Emotion recognition, Brain Stimulation
- Medical subject headings
- Panic Disorder, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial direct current stimulationDevice
Also called tDCS, Direct current stimulation, transcranial electrical stimulation
Participants will receive a total of 10 stimulation sessions. During each session, 2 milliAmpers of active or sham tDCS will be applied for 20 minutes over the dorsolateral prefrontal cortex (left anodal/right anodal).
| Study group | Role | What they receive |
|---|---|---|
| Active Group | Active comparator | Left anodal/right anodal transcranial direct current stimulation over the dorsolateral prefrontal cortex Receives: Device: Transcranial direct current stimulation |
| Sham Group | Sham comparator | Sham transcranial direct current stimulation over the dorsolateral prefrontal cortex Receives: Device: Transcranial direct current stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Panic Disorder Severity Scale (PDSS) scores
The PDSS consists of seven items, each rated on a 5-point scale, which ranges from 0 to 4. The items assess panic frequency, resulting distress, panic-focused anticipatory anxiety, phobic avoidance of situations and of physical sensations, impairment in occupational and social functioning. The overall assessment is made by a total score, which is calculated by summing the scores for all seven items. Minimum score is 0 and maximum score is 28. Higher scores indicate high levels of panic symptomatology. Reduction in score from baseline indicates clinical improvement of panic symptoms.
Measured: Up to one month
Changes in Hamilton Anxiety Rating Scale (HAM-A) scores
The Hamilton Anxiety Rating Scale (HAM-A) is a multiple item questionnaire used to provide an indication of anxiety severity. Higher scores indicate high levels of symptomatology. Minimum score is 0 and maximum score is 56. Reduction in score from baseline indicates clinical symptom improvement.
Measured: Up to one month
Changes in Clinical Global Impression-Severity (CGI-S) scores
Higher scores indicate the presence of high symptom severity. Decrease in scores from baseline reflects clinical symptom improvement. Minimum score is 1 and maximum score is 7. Patients will be classified as responders with a CGI-S = 1 or 2; and partial responders CGI-S = 3.
Measured: Up to one month
Changes in performance on an attentional dot-probe task
Computerized "dot-probe " attentional task will be used. Pairs of emotional faces (neutral/angry or neutral/happy) are randomly presented on a screen. Then, a probe is presented. Subjects are asked to indicate which side the probe approved and need to press the dot after the probe. Total time spent on Region of Interest (angry/neutral face) is measured. Attentional bias towards threat score is the subtraction of median reaction times (milliseconds) in congruent angry versus neutral trials from incongruent angry versus neutral trials. Minimum score is -1000 and maximum score is 1000. Positive scores indicate the presence of attentional vigilance towards threat whereas negative scores indicate an attentional avoidance towards threat.
Measured: Up to one month
Secondary outcomes (8)
Changes in Hamilton Depression Rating Scale (HAM-D) scores
The Hamilton Depression Rating Scale (HAM-D) is a 17-item questionnaire used to provide an indication of depression severity. Minimum score is 0 and maximum score is 52. Higher scores indicate high levels of symptomatology. Reduction in score from baseline indicates clinical symptom improvement.
Measured: Up to one month
Changes in Beck Depression Inventory (BDI) scores
The Beck Depression Inventory is a self-report questionnaire used to provide an indication of depression severity. Minimum score is 0 and maximum score is 63. Higher scores indicate high levels of symptomatology. Reduction in score from baseline indicates clinical symptom improvement.
Measured: Up to one month
Changes in Sheehan Disability Scale (SDS) Work/School scores
The SDS Work/School is a single item measure rated on a 10-point scale. The SDS Work/School measures the extent to which work/school is impaired by symptoms. Minimum score is 0 and maximum score is 10, with higher scores reflecting greater impairment.
Measured: Up to one month
Changes in Sheehan Disability Scale (SDS) Social Life scores
The SDS Social Life is a single item measure rated on a 10-point scale. The SDS Social Life measures the extent to which social life is impaired by symptoms. Minimum score is 0 and maximum score is 10, with higher scores reflecting greater impairment.
Measured: Up to one month
Changes in Sheehan Disability Scale (SDS) Family Life/Home Responsibilities scores
The SDS Family Life/Home Responsibilities is a single item measure rated on a 10-point scale. The SDS Family Life/Home Responsibilities measures the extent to which family life/home responsibilities is impaired by symptoms. Minimum score is 0 and maximum score is 10, with higher scores reflecting greater impairment.
Measured: Up to one month
Changes in Body Vigilance Scale (BVS) scores
BVS is designed to assess conscious attention focused on internal bodily sensations and perturbations. It is an 4-item likert type scale. Minimum score is 0 and maximum score is 40. Higher scores reflect greater body vigilance.
Measured: Up to one month
Changes in Heartbeat Detection Accuracy
Heartbeat detection accuracy is an index ranging between 0 and 1 showing heart rate prediction performance. Higher scores reflect better interoceptive abilities. Heartbeat detection (interoceptive) accuracy is calculated by the following equation: 1/N ∑ (1 - (|recorded heartbeats - counted heartbeats|)/recorded heartbeats). N was the number of blocks for the heartbeat detection task.
Measured: Up to one month
Changes in the number of correct responses at a facial expression recognition task
Participants are presented with individual pictures of facial expressions of emotions. Each presented face displays one of six basic emotions (anger, disgust, fear, happiness, sadness, or surprise). Each emotional expression is presented at different levels of intensity which have been created by combining shape and texture features of the two extremes "neutral" (0%) and "full prototypical emotion" (100%) to varying degrees. Participants are instructed to correctly classify each facial expression as angry, disgusted, fearful, happy, sad, surprised or neutral. Responses are made by pushing one out of six labelled keys on a response box. Hit rates and false alarm rates are measured separately for each emotion. Minimum accuracy percentage of an emotion is 0 and maximum accuracy percentage of an emotion is 100. Higher accuracy rates indicate better emotion recognition.
Measured: Up to one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2019
- Study start1 Nov 2019
- Primary completion1 Nov 2021
- Study completion1 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Panic DisorderStudies of the same condition, open and under way.
- More trials run by Istanbul UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Raşit Tükel, Istanbul University
- Investigators
- Raşit Tükel, Professor, Principal investigator, Istanbul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04160806
- Sponsor's protocol ID
- 2019-141
- Acronym
- PDStim
- Status last verified
- Oct 2022
- First submitted
- 8 Nov 2019
- Last updated
- 4 Oct 2022
- 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 4 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect Of Prefrontal Transcranial Direct Current Stimulation On Clinical Severity, Attentional Bias and Interoceptive Accuracy In Panic Disorder
- ClinicalTrials.gov ID
- NCT04160806
- Acronym / sponsor ID
- PDStim / 2019-141
- Conditions
- Panic Disorder
- Keywords
- Anxiety disorders, Panic disorder, Transcranial Direct Current Stimulation, Interoceptive accuracy, Attention bias, Emotion recognition, Brain Stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 1 Nov 2021 (actual)
- Study completion
- 1 Nov 2021 (actual)
- First posted
- 13 Nov 2019 (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.
The aim of the present study is to investigate the effect of prefrontal transcranial Direct Current Stimulation (tDCS) on clinical severity, attentional bias and interoceptive accuracy in panic disorder (PD).
The participants will be assigned to active and sham groups (1:1) and will receive 10 sessions of tDCS. The study will also examine if the effects may last for a month.
Detailed description
Panic Disorder (PD) is one of the most common anxiety disorders. In spite of several available medications, there are unsatisfactory outcomes in a considerable proportion of PD patients and novel treatment approaches are lacking. Given that response to pharmacotherapeutical and psychological treatments occur after long intervals and medications may cause substantial adverse effects which may affect treatment compliance, fast acting and well-tolerated treatments such as non-invasive brain stimulation are considered to be useful as primary treatment approach or as an add-on treatment in PD. Repetitive Transcranial Magnetic Stimulation (rTMS) trials targeting prefrontal cortex mostly reported favorable outcomes in PD.
Transcranial Direct Current Stimulation (tDCS) is another promising non-invasive brain stimulation method with numerous distinctive aspects including its low-cost, robust safety and tolerability, low dropout rates, easy application, reliable blinding procedures and the opportunity to use concomitantly with other treatments. Left anodal/right anodal tDCS over the dorsolateral prefrontal cortex has been demonstrated to decrease attentional bias and amygdala reactivity to threat in individuals with high trait anxiety. Moreover, a treatment-resistant case of PD was reported to have significant amelioration of symptoms up to one month after 10 sessions of tDCS.
The study is a triple-blind randomized controlled trial. The sample will be consisted of thirty participants diagnosed as having PD due to Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria. The participants will be assigned to active or sham groups equally. Clinical severity will be assessed with adequate scales. Emotion recognition, attentional bias to threat and interoceptive accuracy will also be measured. Then, participants will be applied ten active or sham sessions of left anodal/right cathodal tDCS over the dorsolateral prefrontal cortex (DLPFC). All measurements will be repeated after the applications. Succinctly, the aim of this study is to assess the effect of ten sessions left anodal/right cathodal tDCS over the DLPFC on clinical severity, attentional bias and interoceptive accuracy in PD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Group | Active comparator | Device: Transcranial direct current stimulationLeft anodal/right anodal transcranial direct current stimulation over the dorsolateral prefrontal cortex |
| Sham Group | Sham comparator | Device: Transcranial direct current stimulationSham transcranial direct current stimulation over the dorsolateral prefrontal cortex |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Patients with a primary diagnosis of Panic Disorder, as confirmed by the Structured Clinical Interview for the DSM-5 (SCID-5);
- Patients currently on medication must be at the same stable dose(s) for one month prior to enrollment and be willing to continue at the same dose(s) through the duration of the study;
- Right-hand dominancy assessed by Edinburgh Handedness Inventory;
- Willingness and ability to comply with the requirements of the study protocol;
- Naïve to tDCS.
Key exclusion criteria (13 listed)
- Illiteracy, deficient language or refusal to participate or being not able to follow instructions or complete study tasks;
- Less than 5 years of education
- Individuals with any current or lifetime diagnosis of other Axis I disorders, as confirmed by the Structured Clinical Interview for the DSM-5 (SCID-5);
- History of substance or psychoactive compound use,with the exception of nicotine consumption;
- The presence of mental retardation diagnosis (previously identified)
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 |
|---|---|---|
| Transcranial direct current stimulationAlso: tDCS, Direct current stimulation, transcranial electrical stimulationParticipants will receive a total of 10 stimulation sessions. During each session, 2 milliAmpers of active or sham tDCS will be applied for 20 minutes over the dorsolateral prefrontal cortex (left anodal/right anodal). | Device | Active Group, Sham Group |
Primary outcome
Changes in Panic Disorder Severity Scale (PDSS) scores
Time frame: Up to one month
The PDSS consists of seven items, each rated on a 5-point scale, which ranges from 0 to 4. The items assess panic frequency, resulting distress, panic-focused anticipatory anxiety, phobic avoidance of situations and of physical sensations, impairment in occupational and social functioning. The overall assessment is made by a total score, which is calculated by summing the scores for all seven items. Minimum score is 0 and maximum score is 28. Higher scores indicate high levels of panic symptomatology. Reduction in score from baseline indicates clinical improvement of panic symptoms.
Changes in Hamilton Anxiety Rating Scale (HAM-A) scores
Time frame: Up to one month
The Hamilton Anxiety Rating Scale (HAM-A) is a multiple item questionnaire used to provide an indication of anxiety severity. Higher scores indicate high levels of symptomatology. Minimum score is 0 and maximum score is 56. Reduction in score from baseline indicates clinical symptom improvement.
Changes in Clinical Global Impression-Severity (CGI-S) scores
Time frame: Up to one month
Higher scores indicate the presence of high symptom severity. Decrease in scores from baseline reflects clinical symptom improvement. Minimum score is 1 and maximum score is 7. Patients will be classified as responders with a CGI-S = 1 or 2; and partial responders CGI-S = 3.
Changes in performance on an attentional dot-probe task
Time frame: Up to one month
Computerized "dot-probe " attentional task will be used. Pairs of emotional faces (neutral/angry or neutral/happy) are randomly presented on a screen. Then, a probe is presented. Subjects are asked to indicate which side the probe approved and need to press the dot after the probe. Total time spent on Region of Interest (angry/neutral face) is measured. Attentional bias towards threat score is the subtraction of median reaction times (milliseconds) in congruent angry versus neutral trials from incongruent angry versus neutral trials. Minimum score is -1000 and maximum score is 1000. Positive scores indicate the presence of attentional vigilance towards threat whereas negative scores indicate an attentional avoidance towards threat.
8 secondary outcomes
Changes in Hamilton Depression Rating Scale (HAM-D) scores
Time frame: Up to one month
Changes in Beck Depression Inventory (BDI) scores
Time frame: Up to one month
Changes in Sheehan Disability Scale (SDS) Work/School scores
Time frame: Up to one month
Changes in Sheehan Disability Scale (SDS) Social Life scores
Time frame: Up to one month
Changes in Sheehan Disability Scale (SDS) Family Life/Home Responsibilities scores
Time frame: Up to one month
Changes in Body Vigilance Scale (BVS) scores
Time frame: Up to one month
Changes in Heartbeat Detection Accuracy
Time frame: Up to one month
Changes in the number of correct responses at a facial expression recognition task
Time frame: Up to one month
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 4 Oct 2022.
- 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.
Raşit Tükel, Professor principal investigator
Istanbul University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial direct current stimulation in people with Panic Disorder, run by Istanbul University at 1 site in Turkey (Türkiye).
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 6 inclusion and 13 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 4 Oct 2022. 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 Turkey (Türkiye). 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?
Changes in Panic Disorder Severity Scale (PDSS) scores (time frame: Up to one month). 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 4 Oct 2022.