Back to resultsThe Effect Of Transcranial Direct Current Stimulation In Panic Disorder (PDStim)
Primary Purpose
Panic Disorder
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Transcranial direct current stimulation
Sponsored by
About this trial
This is an interventional treatment trial for Panic Disorder focused on measuring Anxiety disorders, Panic disorder, Transcranial Direct Current Stimulation, Interoceptive accuracy, Attention bias, Emotion recognition, Brain Stimulation
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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;
- 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.
Sites / Locations
- Department Of Psychiatry, Istanbul University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Sham Comparator
Arm Label
Active Group
Sham Group
Arm Description
Left anodal/right anodal transcranial direct current stimulation over the dorsolateral prefrontal cortex
Sham transcranial direct current stimulation over the dorsolateral prefrontal cortex
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
Secondary Outcome Measures
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.
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.
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.
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.
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.
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04160806
Brief Title
The Effect Of Transcranial Direct Current Stimulation In Panic Disorder
Acronym
PDStim
Official Title
The Effect Of Prefrontal Transcranial Direct Current Stimulation On Clinical Severity, Attentional Bias and Interoceptive Accuracy In Panic Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
November 1, 2019 (Actual)
Primary Completion Date
November 1, 2021 (Actual)
Study Completion Date
November 1, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Panic Disorder
Keywords
Anxiety disorders, Panic disorder, Transcranial Direct Current Stimulation, Interoceptive accuracy, Attention bias, Emotion recognition, Brain Stimulation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Active Group
Arm Type
Active Comparator
Arm Description
Left anodal/right anodal transcranial direct current stimulation over the dorsolateral prefrontal cortex
Arm Title
Sham Group
Arm Type
Sham Comparator
Arm Description
Sham transcranial direct current stimulation over the dorsolateral prefrontal cortex
Intervention Type
Device
Intervention Name(s)
Transcranial direct current stimulation
Other Intervention Name(s)
tDCS, Direct current stimulation, transcranial electrical stimulation
Intervention Description
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).
Primary Outcome Measure Information:
Title
Changes in Panic Disorder Severity Scale (PDSS) scores
Description
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.
Time Frame
Up to one month
Title
Changes in Hamilton Anxiety Rating Scale (HAM-A) scores
Description
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.
Time Frame
Up to one month
Title
Changes in Clinical Global Impression-Severity (CGI-S) scores
Description
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.
Time Frame
Up to one month
Title
Changes in performance on an attentional dot-probe task
Description
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.
Time Frame
Up to one month
Secondary Outcome Measure Information:
Title
Changes in Hamilton Depression Rating Scale (HAM-D) scores
Description
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.
Time Frame
Up to one month
Title
Changes in Beck Depression Inventory (BDI) scores
Description
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.
Time Frame
Up to one month
Title
Changes in Sheehan Disability Scale (SDS) Work/School scores
Description
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.
Time Frame
Up to one month
Title
Changes in Sheehan Disability Scale (SDS) Social Life scores
Description
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.
Time Frame
Up to one month
Title
Changes in Sheehan Disability Scale (SDS) Family Life/Home Responsibilities scores
Description
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.
Time Frame
Up to one month
Title
Changes in Body Vigilance Scale (BVS) scores
Description
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.
Time Frame
Up to one month
Title
Changes in Heartbeat Detection Accuracy
Description
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.
Time Frame
Up to one month
Title
Changes in the number of correct responses at a facial expression recognition task
Description
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.
Time Frame
Up to one month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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;
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Raşit Tükel, Professor
Organizational Affiliation
Istanbul University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department Of Psychiatry, Istanbul University
City
Istanbul
ZIP/Postal Code
34060
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Effect Of Transcranial Direct Current Stimulation In Panic Disorder
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