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Trial Outcomes & Findings for Transcranial Magnetic Stimulation Treatment for Generalized Anxiety Disorder (NCT NCT01659736)

NCT ID: NCT01659736

Last Updated: 2016-04-27

Results Overview

Structured Interview Guide for the Hamilton Anxiety Rating Scale (SIGH-A) scores range from 0-56 with higher scores indicating more severe anxiety.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

26 participants

Primary outcome timeframe

Pretreatment, Post-treatment (6 weeks after pretreatment), 3-month follow-up

Results posted on

2016-04-27

Participant Flow

Participant milestones

Participant milestones
Measure
TMS-Treatment
TMS treatment TMS: Treatment will entail daily (5 days/week) sessions of TMS for 6 weeks. Treatment in the substudy will entail 2 days/week sessions of TMS for 5 weeks.
TMS-Sham
This is a sham TMS condition TMS: Treatment will entail daily (5 days/week) sessions of TMS for 6 weeks. Treatment in the substudy will entail 2 days/week sessions of TMS for 5 weeks.
Treatment Period
STARTED
14
12
Treatment Period
COMPLETED
9
10
Treatment Period
NOT COMPLETED
5
2
3-month Follow-up
STARTED
9
10
3-month Follow-up
COMPLETED
9
9
3-month Follow-up
NOT COMPLETED
0
1

Reasons for withdrawal

Reasons for withdrawal
Measure
TMS-Treatment
TMS treatment TMS: Treatment will entail daily (5 days/week) sessions of TMS for 6 weeks. Treatment in the substudy will entail 2 days/week sessions of TMS for 5 weeks.
TMS-Sham
This is a sham TMS condition TMS: Treatment will entail daily (5 days/week) sessions of TMS for 6 weeks. Treatment in the substudy will entail 2 days/week sessions of TMS for 5 weeks.
Treatment Period
Adverse Event
1
1
Treatment Period
Protocol Violation
3
1
Treatment Period
Withdrawal by Subject
1
0
3-month Follow-up
Lost to Follow-up
0
1

Baseline Characteristics

Transcranial Magnetic Stimulation Treatment for Generalized Anxiety Disorder

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
TMS Therapy
n=13 Participants
TMS treatment TMS: Treatment will entail daily (5 days/week) sessions of TMS for 6 weeks. Treatment in the substudy will entail 2 days/week sessions of TMS for 5 weeks.
TMS-Sham
n=12 Participants
This is a sham TMS condition TMS: Treatment will entail daily (5 days/week) sessions of TMS for 6 weeks. Treatment in the substudy will entail 2 days/week sessions of TMS for 5 weeks.
Total
n=25 Participants
Total of all reporting groups
Age, Continuous
44.00 years
STANDARD_DEVIATION 11.95 • n=5 Participants
44.58 years
STANDARD_DEVIATION 14.75 • n=7 Participants
44.28 years
STANDARD_DEVIATION 13.09 • n=5 Participants
Sex: Female, Male
Female
11 Participants
n=5 Participants
8 Participants
n=7 Participants
19 Participants
n=5 Participants
Sex: Female, Male
Male
2 Participants
n=5 Participants
4 Participants
n=7 Participants
6 Participants
n=5 Participants
Region of Enrollment
United States
13 participants
n=5 Participants
12 participants
n=7 Participants
25 participants
n=5 Participants

PRIMARY outcome

Timeframe: Pretreatment, Post-treatment (6 weeks after pretreatment), 3-month follow-up

Population: Intent-to-treat sample (n = 25)

Structured Interview Guide for the Hamilton Anxiety Rating Scale (SIGH-A) scores range from 0-56 with higher scores indicating more severe anxiety.

Outcome measures

Outcome measures
Measure
TMS-Treatment
n=13 Participants
TMS treatment TMS: Treatment will entail daily (5 days/week) sessions of TMS for 6 weeks. Treatment in the substudy will entail 2 days/week sessions of TMS for 5 weeks.
TMS-Sham
n=12 Participants
This is a sham TMS condition TMS: Treatment will entail daily (5 days/week) sessions of TMS for 6 weeks. Treatment in the substudy will entail 2 days/week sessions of TMS for 5 weeks.
Change in the Structured Interview Guide for the Hamilton Anxiety Rating Scale (SIGH-A) at Post-treatment and 3-month Follow-up.
pre-treatment
25.31 units on a scale
Standard Deviation 5.23
20.75 units on a scale
Standard Deviation 3.72
Change in the Structured Interview Guide for the Hamilton Anxiety Rating Scale (SIGH-A) at Post-treatment and 3-month Follow-up.
post-treatment
12.10 units on a scale
Standard Deviation 5.77
14.38 units on a scale
Standard Deviation 4.78
Change in the Structured Interview Guide for the Hamilton Anxiety Rating Scale (SIGH-A) at Post-treatment and 3-month Follow-up.
3-month follow-up
10.36 units on a scale
Standard Deviation 7.86
17.95 units on a scale
Standard Deviation 7.48

PRIMARY outcome

Timeframe: Post-treatment, 6 weeks

Population: Post-treatment completers

Structured Interview Guide for the Hamilton Anxiety Rating Scale (SIGH-A) scores range from 0-56 with higher scores indicating more severe anxiety. Responder status was defined as a ≥ 50% improvement (i.e., reduction) in SIGH-A scores from pre-treatment to post-treatment.

Outcome measures

Outcome measures
Measure
TMS-Treatment
n=9 Participants
TMS treatment TMS: Treatment will entail daily (5 days/week) sessions of TMS for 6 weeks. Treatment in the substudy will entail 2 days/week sessions of TMS for 5 weeks.
TMS-Sham
n=10 Participants
This is a sham TMS condition TMS: Treatment will entail daily (5 days/week) sessions of TMS for 6 weeks. Treatment in the substudy will entail 2 days/week sessions of TMS for 5 weeks.
Responder Status
7 participants
2 participants

PRIMARY outcome

Timeframe: post-treatment, 6 weeks

Population: Post-treatment completers

Structured Interview Guide for the Hamilton Anxiety Rating Scale (SIGH-A) scores range from 0-56 with higher scores indicating more severe anxiety. Remission status was defined as a SIGH-A score \< 8 and Clinical Global Impression Improvement score = 1 ("very much improved") or 2 ("much improved") at post-treatment.

Outcome measures

Outcome measures
Measure
TMS-Treatment
n=9 Participants
TMS treatment TMS: Treatment will entail daily (5 days/week) sessions of TMS for 6 weeks. Treatment in the substudy will entail 2 days/week sessions of TMS for 5 weeks.
TMS-Sham
n=10 Participants
This is a sham TMS condition TMS: Treatment will entail daily (5 days/week) sessions of TMS for 6 weeks. Treatment in the substudy will entail 2 days/week sessions of TMS for 5 weeks.
Remission Status
3 participants
1 participants

PRIMARY outcome

Timeframe: 3-month follow-up

Population: 3-month follow-up completers

Structured Interview Guide for the Hamilton Anxiety Rating Scale (SIGH-A) scores range from 0-56 with higher scores indicating more severe anxiety. Responder status was defined as a ≥ 50% improvement (i.e., reduction) in SIGH-A scores from pre-treatment to 3-month follow-up.

Outcome measures

Outcome measures
Measure
TMS-Treatment
n=9 Participants
TMS treatment TMS: Treatment will entail daily (5 days/week) sessions of TMS for 6 weeks. Treatment in the substudy will entail 2 days/week sessions of TMS for 5 weeks.
TMS-Sham
n=9 Participants
This is a sham TMS condition TMS: Treatment will entail daily (5 days/week) sessions of TMS for 6 weeks. Treatment in the substudy will entail 2 days/week sessions of TMS for 5 weeks.
Responder Status
7 participants
0 participants

PRIMARY outcome

Timeframe: 3-month follow-up

Population: 3-month follow-up completers

Structured Interview Guide for the Hamilton Anxiety Rating Scale (SIGH-A) scores range from 0-56 with higher scores indicating more severe anxiety. Remission status was defined as a SIGH-A score \< 8 and Clinical Global Impression Improvement score = 1 ("very much improved") or 2 ("much improved") at 3-month follow-up.

Outcome measures

Outcome measures
Measure
TMS-Treatment
n=9 Participants
TMS treatment TMS: Treatment will entail daily (5 days/week) sessions of TMS for 6 weeks. Treatment in the substudy will entail 2 days/week sessions of TMS for 5 weeks.
TMS-Sham
n=9 Participants
This is a sham TMS condition TMS: Treatment will entail daily (5 days/week) sessions of TMS for 6 weeks. Treatment in the substudy will entail 2 days/week sessions of TMS for 5 weeks.
Remission Status
6 participants
0 participants

Adverse Events

TMS-Treatment

Serious events: 1 serious events
Other events: 13 other events
Deaths: 0 deaths

TMS-Sham

Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure
TMS-Treatment
n=13 participants at risk
TMS treatment TMS: Treatment will entail daily (5 days/week) sessions of TMS for 6 weeks. Treatment in the substudy will entail 2 days/week sessions of TMS for 5 weeks.
TMS-Sham
n=12 participants at risk
This is a sham TMS condition TMS: Treatment will entail daily (5 days/week) sessions of TMS for 6 weeks. Treatment in the substudy will entail 2 days/week sessions of TMS for 5 weeks.
Cardiac disorders
Chest Pain
7.7%
1/13 • Number of events 1
0.00%
0/12

Other adverse events

Other adverse events
Measure
TMS-Treatment
n=13 participants at risk
TMS treatment TMS: Treatment will entail daily (5 days/week) sessions of TMS for 6 weeks. Treatment in the substudy will entail 2 days/week sessions of TMS for 5 weeks.
TMS-Sham
n=12 participants at risk
This is a sham TMS condition TMS: Treatment will entail daily (5 days/week) sessions of TMS for 6 weeks. Treatment in the substudy will entail 2 days/week sessions of TMS for 5 weeks.
Nervous system disorders
Pin Prick Sensation
69.2%
9/13
83.3%
10/12
Nervous system disorders
Pain at the stimulation site
84.6%
11/13
66.7%
8/12
Nervous system disorders
Facial pain (including eye pain)
23.1%
3/13
8.3%
1/12
Nervous system disorders
Headache
46.2%
6/13
25.0%
3/12
Nervous system disorders
Toothache
23.1%
3/13
0.00%
0/12
Nervous system disorders
Lightheaded or Dizziness
0.00%
0/13
16.7%
2/12
Nervous system disorders
Facial twitch
46.2%
6/13
0.00%
0/12

Additional Information

Gretchen J. Diefenbach, Ph.D

The Institute of Living

Phone: 860-545-7685

Results disclosure agreements

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