Trial Outcomes & Findings for Transcranial Magnetic Stimulation Treatment for Generalized Anxiety Disorder (NCT NCT01815099)

Last Updated: 2017-04-10

Results Overview

The Hamilton Anxiety Rating Scale (HARS) is one of the most commonly used and extensively validated outcome measures for anxiety symptoms. The SIGH-A allows for a standardized administration of the HARS. The total score was used in this study. The total score ranges from 0 to 56 with higher scores indicative of more severe anxiety symptoms.

Recruitment status

TERMINATED

Study phase

Target enrollment

4 participants

Primary outcome timeframe

Approximately 1 week prior to initial TMS treatment session, 1 week after final TMS treatment session

Results posted on

2017-04-10

Participant Flow

Participant milestones

Participant milestones
Measure	rTMS Treatment This was an open trial. All participants received active rTMS
Overall Study STARTED	4
Overall Study Began rTMS Treatment	3
Overall Study COMPLETED	2
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	rTMS Treatment This was an open trial. All participants received active rTMS
Overall Study Lack of Efficacy	1
Overall Study unable to attend study visits	1

Baseline Characteristics

Transcranial Magnetic Stimulation Treatment for Generalized Anxiety Disorder

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	rTMS Treatment n=4 Participants rTMS Treatment: will entail twice weekly rTMS sessions for 5 weeks.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Age, Continuous	42.75 years STANDARD_DEVIATION 15.10 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants
Region of Enrollment United States	4 Participants n=5 Participants

PRIMARY outcome

Timeframe: Approximately 1 week prior to initial TMS treatment session, 1 week after final TMS treatment session

Population: rTMS treatment completers

Outcome measures

Outcome measures
Measure	Pre rTMS Treatment n=2 Participants Assessment before beginning rTMS treatment	Post rTMS Treatment n=2 Participants Assessment After Completing rTMS
Change in The Structured Interview Guide for the Hamilton Anxiety Rating Scale (SIGH-A) Before and After TMS Treatment.	20.00 units on a scale Standard Deviation 4.24	10.50 units on a scale Standard Deviation 0.71

Adverse Events

rTMS Treatment

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	rTMS Treatment n=3 participants at risk rTMS Treatment: will entail twice weekly rTMS sessions for 5 weeks.
Skin and subcutaneous tissue disorders pin prick sensation at treatment site	66.7% 2/3 • AE data were collected over 5 weeks of treatment
Skin and subcutaneous tissue disorders pain or discomfort at treatment site	100.0% 3/3 • AE data were collected over 5 weeks of treatment
Nervous system disorders headache	66.7% 2/3 • AE data were collected over 5 weeks of treatment
Eye disorders eye pain	33.3% 1/3 • AE data were collected over 5 weeks of treatment
Musculoskeletal and connective tissue disorders toothache	66.7% 2/3 • AE data were collected over 5 weeks of treatment
Musculoskeletal and connective tissue disorders face pain	66.7% 2/3 • AE data were collected over 5 weeks of treatment
Musculoskeletal and connective tissue disorders eye or jaw twitch	33.3% 1/3 • AE data were collected over 5 weeks of treatment

Additional Information

Gretchen Diefenbach

Hartford Hospital

Phone: 860-545-7685

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place