Trial Outcomes & Findings for TMS Augmented Exposure Therapy (NCT NCT02223767)

NCT ID: NCT02223767

Last Updated: 2023-08-02

Results Overview

Change in anxiety questionaire (Agoraphobia Questionaire (AQ), subscale anxiety) from pre (baseline) to post therapy (week 4). The range of the scale is from 0 to 120. Higher values indicate higher anxiety symptoms. For the calculated changes from pre to post this means, that more negative values indicate higher symptom reductions

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 47 participants
• Primary outcome timeframe: 4 weeks
• Results posted on: 2023-08-02

Participant Flow

Participant milestones

Measure	Verum TMS 10 Hz transcranial magnetic stimulation (TMS) over medial prefrontal cortex Experimental: Verum TMS: Intensity of 100 % of the resting motor threshold with 10 Hz and intertrial interval (ITI) of 26 s. 1560 pulse in 40 trains at all . One train lasts 4 s.	Sham TMS 10 Hz sham TMS over medial prefrontal cortex Experimental: Sham TMS: Sham stimulation with 10 Hz and ITI of 26 s. 1560 pulse in 40 trains at all . One train lasts 4 s.
Overall Study STARTED	24	23
Overall Study COMPLETED	20	19
Overall Study NOT COMPLETED	4	4

Reasons for withdrawal

Measure	Verum TMS 10 Hz transcranial magnetic stimulation (TMS) over medial prefrontal cortex Experimental: Verum TMS: Intensity of 100 % of the resting motor threshold with 10 Hz and intertrial interval (ITI) of 26 s. 1560 pulse in 40 trains at all . One train lasts 4 s.	Sham TMS 10 Hz sham TMS over medial prefrontal cortex Experimental: Sham TMS: Sham stimulation with 10 Hz and ITI of 26 s. 1560 pulse in 40 trains at all . One train lasts 4 s.
Overall Study Withdrawal by Subject	4	4

Baseline Characteristics

TMS Augmented Exposure Therapy

Baseline characteristics by cohort

Measure	Verum TMS n=20 Participants 10 Hz TMS over medial prefrontal cortex Experimental: Verum TMS: Intensity of 100 % of the resting motor threshold with 10 Hz and ITI of 26 s. 1560 pulse in 40 trains at all . One train lasts 4 s.	Sham TMS n=19 Participants 10 Hz sham TMS over medial prefrontal cortex Experimental: Sham TMS: Sham stimulation with 10 Hz and ITI of 26 s. 1560 pulse in 40 trains at all . One train lasts 4 s.	Total n=39 Participants Total of all reporting groups
Age, Continuous	43.2 years STANDARD_DEVIATION 12.6 • n=5 Participants	46.6 years STANDARD_DEVIATION 13.7 • n=7 Participants	44.9 years STANDARD_DEVIATION 13.1 • n=5 Participants
Sex: Female, Male Female	13 Participants n=5 Participants	13 Participants n=7 Participants	26 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	6 Participants n=7 Participants	13 Participants n=5 Participants
Region of Enrollment Germany	20 participants n=5 Participants	19 participants n=7 Participants	39 participants n=5 Participants

PRIMARY outcome

Timeframe: 4 weeks

Change in anxiety questionaire (Agoraphobia Questionaire (AQ), subscale anxiety) from pre (baseline) to post therapy (week 4). The range of the scale is from 0 to 120. Higher values indicate higher anxiety symptoms. For the calculated changes from pre to post this means, that more negative values indicate higher symptom reductions

Outcome measures

Measure	Verum TMS n=20 Participants 10 Hz TMS over medial prefrontal cortex Experimental: Verum TMS: Intensity of 100 % of the resting motor threshold with 10 Hz and ITI of 26 s. 1560 pulse in 40 trains at all . One train lasts 4 s.	Sham TMS n=19 Participants 10 Hz sham TMS over medial prefrontal cortex Experimental: Sham TMS: Sham stimulation with 10 Hz and ITI of 26 s. 1560 pulse in 40 trains at all . One train lasts 4 s.
Subjective Anxiety Symptoms	17.4 units on a scale Standard Deviation 15.3	7.3 units on a scale Standard Deviation 11.6

PRIMARY outcome

Timeframe: 4 weeks

real life anxiety measurement by an behavioral approach test. Ratings on a 0-100 scale. Higher values indicate higher anxiety

Outcome measures

Measure	Verum TMS n=20 Participants 10 Hz TMS over medial prefrontal cortex Experimental: Verum TMS: Intensity of 100 % of the resting motor threshold with 10 Hz and ITI of 26 s. 1560 pulse in 40 trains at all . One train lasts 4 s.	Sham TMS n=19 Participants 10 Hz sham TMS over medial prefrontal cortex Experimental: Sham TMS: Sham stimulation with 10 Hz and ITI of 26 s. 1560 pulse in 40 trains at all . One train lasts 4 s.
Subjective Anxiety in Height Situation (BAT), Differences From Pre (Baseline) to Post Therapy (Week 4)	25.8 units on a scale Standard Deviation 25.4	16.3 units on a scale Standard Deviation 13.2

Adverse Events

Verum TMS

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Sham TMS

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Verum TMS n=20 participants at risk 10 Hz TMS over medial prefrontal cortex Experimental: Verum TMS: Intensity of 100 % of the resting motor threshold with 10 Hz and ITI of 26 s. 1560 pulse in 40 trains at all . One train lasts 4 s.	Sham TMS n=19 participants at risk 10 Hz sham TMS over medial prefrontal cortex Experimental: Sham TMS: Sham stimulation with 10 Hz and ITI of 26 s. 1560 pulse in 40 trains at all . One train lasts 4 s.
Nervous system disorders Headache	35.0% 7/20 • Number of events 7 • 3 month	5.3% 1/19 • Number of events 1 • 3 month
Nervous system disorders drowsiness	5.0% 1/20 • Number of events 1 • 3 month	0.00% 0/19 • 3 month
Musculoskeletal and connective tissue disorders neck pain	0.00% 0/20 • 3 month	10.5% 2/19 • Number of events 2 • 3 month

Additional Information

Prof. Dr. M Herrmann

Universitätsklinikum Würzburg

Phone: 093120176650

Email: Herrmann_m@ukw.de

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place