An interventional study of Transcutaneous Vagus Nerve Stimulation in Generalized Anxiety Disorder, Chronic Pain and Irritable Bowel Syndrome, sponsored by Kinesis Health Associates. Completed at 1 site in Canada. Open to participants aged 20 Years to 65 Years. Per ClinicalTrials.gov, last updated 2018-02-22.
Sponsored by Kinesis Health Associates · Not applicable, Interventional, and Treatment
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Among 50 studies in Generalized Anxiety Disorder with a site in Canada — 7 open to participants now, 11 under way, none of them phase 3. Generalized Anxiety Disorder · Canada.
Among the 50 studies in Generalized Anxiety Disorder with a site in Canada, this one is the 36th largest by enrollment of the 45 interventional ones that give a count, is one of 2 that started in 2017, is one of 32 with no phase, and was the 21st registered.
518 studies on the registry are indexed under Generalized Anxiety Disorder; 125 are open to participants now.
Browse Generalized Anxiety Disorder studies →7 of the 50 studies in Generalized Anxiety Disorder with a site in Canada are open now. Recruiting first, the newest first:
Claudio N Soares · Sites in Canada
Ages 18–60
Fraser Health · Sites in Canada
Ages 19+
Queen's University · Sites in Canada
Ages 18–65
Universite du Quebec en Outaouais · Sites in Canada
Ages 14–18 · Healthy volunteers
Dr. Rafael Freire · Sites in Canada
Ages 18–65
A study can be open while its sites in Canada have not opened yet or have stopped. Only those recruiting at a site in Canada →
Of the 86 Generalized Anxiety Disorder studies recruiting now, 32 (37%) set no upper age limit and 52 (60%) stop at 75 or younger; 15 take children under 18; 16 take healthy volunteers.
This study: 20 Years to 65 Years · all sexes · no healthy volunteers.
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50 studies; the count open now beside each. This study's row is marked.
First in 2005; this study’s year is marked. 2 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 11 is below the median of 83 across 440 interventional studies indexed under Generalized Anxiety Disorder.
Median enrollment 63 across the 45 interventional studies, 380 across the 5 observational. Of the 34 that completed or were terminated, 3 (9%) have results posted.
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6 of 50 have an industry lead sponsor. The 10 most frequent:
This is the only study on the registry with Kinesis Health Associates as lead sponsor.
Kinesis Health Associates has 1 study filed under Generalized Anxiety Disorder — fewer than ten, so there is no comparison to draw.
2 of the studies in Generalized Anxiety Disorder with a site in Canada that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06856161Fraser HealthA Novel Blood Test as a Biomarker in Mental Health | 2027-03-15 |
| NCT05574140McGill University Health Centre/Research Institute of the McGill University Health CentreBreathinG-induced Myocardial and Cerebral Perfusion in Anxiety Disorders | 2027-05-01 |
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Among the 50 studies in Generalized Anxiety Disorder with a site in Canada, from their registry updates:
This tab as a report to print or save as PDF → With an account.
This non-randomized, open-label study has the objective to study the effects and feasibility of Transauricular Vagus Nerve Stimulation (TaVNS) for patients suffering from Generalized Anxiety Disorder (GAD), Chronic Pain (CP) and Irritable Bowel Syndrome (IBS) in a private healthcare centre.
The effects of TaVNS on GAD, CP and IBS. Participants were investigated during a 4-week period and a 2-month follow-up. Groups (GAD, CP, IBS) were assessed using questionnaires: Anxiety (Generalized Anxiety Disorder GAD-7); CP (Brief Pain Inventory Short Form Questionnaire) and IBS (Irritable Bowel Syndrome Severity Scoring System). TaVNS was performed using a standard transcutaneous electrical nerve stimulation (TENS) device and ear clip electrodes plugged into the concha area of the left ear. All participants received a bi-weekly 30 minutes stimulation (8 sessions). We defined three different TaVNS parameters for each group in hertz (Hz) and microsecond (µs), (GAD: 20Hz-80µs), (CP: 5Hz-200 µs), (IBS: 3Hz-250µs).
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Exclusion Criteria:
TaVNS 8 sessions, 30 min, 4 weeks GAD: 20 Hertz (Hz) - 80 microseconds (µs) CP: 5Hz-200µs IBS: 3Hz-250µs
Device: Transcutaneous Vagus Nerve Stimulation
TaVNS will be applied by the TENS 7000 device. The stimulation was set according the group of treatment: (GAD: 20Hz-80µs), (CP: 5Hz-200 µs), (IBS: 3Hz-250µs). The current intensity was individually established under the pain threshold .The stimulus generates an continous asymmetric biphasic waveform. Ear clip electrodes were plugged in the concha area of the left ear. The stimulation will last 30 min per session (total=8)
Change from baseline generalized anxiety disorder severity
To assess the response effect of the TaVNS on the severity of anxiety disorders measured by the 21 items self-administered Generalized Anxiety Disorder GAD-7 questionnaire, where scoring scores of 5, 10 and 15 represent cut-off points for mild, moderate and severe anxiety. A response will be considered as a reduced cut-off point from baseline.
Time frame: baseline, 4-week and 2-month follow-up
Change from baseline pain severity and pain interference
To assess the response effect of the TaVNS on the severity of pain and the impact of this pain on daily functioning (Interference) measured by the 9 items self-administered Brief Pain Inventory (Short Form) questionnaire; from 0 (no pain) to 10 (worst pain), ratings from 1 to 4 corresponded to mild pain, 5 to 6 to moderate pain, and 7 to 10 to severe pain with cut-off points being 4 and 6. Scoring pain severity is the mean of the total pain score out of 10. Interference from 0 (no interference) to 10 (completely interferes), rating mild (\<=5), moderate (6-7), and severe (\>= 8) with cut-off points being 5 and 7. Scoring the interference severity is the mean of the total Interference score out of 10. A response will be considered as a reduced cut-off point from baseline.
Time frame: baseline, 4-week and 2-month follow-up
Change from baseline irritable bowels syndrome severity
To assess the response effect of the TaVNS on the severity of irritable bowel syndrome measured by the self-administered Irritable Bowel Syndrome Severity Scoring System (IBS-SSS), where the maximum achievable score is 500. Mild, moderate and severe categories were indicated by scores of 75 to 175, 175 to 300 and \> 300 respectively, with cut-off points being 175 and 300. A response will be considered as a reduced cut-off point from baseline.
Time frame: baseline, 4-week and 2-month follow-up
Plan to share: Undecided
Ran from Jul 2017 to primary completion in Jul 2017, 0 months.
Of 174 non-industry interventional studies with no phase under Generalized Anxiety Disorder, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 55. This study's 0 months is below that.
Counting every sponsor, half of 183 studies reached it within 28 months; a quarter within 15 and three quarters within 53.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.
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Generalized Anxiety Disorder →