Trial Outcomes & Findings for Transcranial Magnetic Stimulation for Facial Pain (NCT NCT02633306)

Results Overview

Participants are asked to rate pain on a100 mm visual analogue scale with 0 representing no pain and 100 representing worst possible pain. The mean difference from baseline to 7 days post-treatment is recorded.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

9 participants

Primary outcome timeframe

7 days

Results posted on

2021-04-08

Participant Flow

Participant milestones

Participant milestones
Measure	Transcranial Magnetic Stimulation transcranial magnetic stimulation transcranial magnetic stimulation: Treatment will consist of five daily sessions of transcranial magnetic stimulation of the motor cortex contralateral to the pain.
Overall Study STARTED	9
Overall Study COMPLETED	6
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Transcranial Magnetic Stimulation transcranial magnetic stimulation transcranial magnetic stimulation: Treatment will consist of five daily sessions of transcranial magnetic stimulation of the motor cortex contralateral to the pain.
Overall Study Withdrawal by Subject	3

Baseline Characteristics

Transcranial Magnetic Stimulation for Facial Pain

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Transcranial Magnetic Stimulation n=7 Participants transcranial magnetic stimulation transcranial magnetic stimulation: Treatment will consist of five daily sessions of transcranial magnetic stimulation of the motor cortex contralateral to the pain.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	5 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	7 Participants n=5 Participants
Region of Enrollment United States	7 participants n=5 Participants

PRIMARY outcome

Timeframe: 7 days

Population: Three patients left the study before treatment. One of 6 patients who began treatment did not complete the full treatment regimen and therefore post treatment status could not be assessed.

Participants are asked to rate pain on a100 mm visual analogue scale with 0 representing no pain and 100 representing worst possible pain. The mean difference from baseline to 7 days post-treatment is recorded.

Outcome measures

Outcome measures
Measure	Transcranial Magnetic Stimulation n=5 Participants transcranial magnetic stimulation transcranial magnetic stimulation: Treatment will consist of five daily sessions of transcranial magnetic stimulation of the motor cortex contralateral to the pain.
Visual Analogue Scale (VAS)	5.4 score on a scale Standard Deviation 11.7

SECONDARY outcome

Timeframe: pre-treatment, 3 and 7 days post treatment

Population: All enrolled patients for whom any data was acquired are included.

A questionnaire used to determine the impact and burden of a disease on daily life. This assessment has 26 questions and covers the domains of physical and psychological health, social relationships, and environment. The answers to various question are included in one or more of the domains. Raw scores are transformed in several different ways by different investigators. We report raw scores. Domains have the following raw score ranges: Overall Quality of Life 2-10, Physical Heath 7-35, Psychological Health 6-30, Social Relationships 3-15, Environment 8-40, Total Raw Score 26-130. Higher scores in each of the domains correspond to greater perceived quality of life.

Outcome measures

Outcome measures
Measure	Transcranial Magnetic Stimulation n=9 Participants transcranial magnetic stimulation transcranial magnetic stimulation: Treatment will consist of five daily sessions of transcranial magnetic stimulation of the motor cortex contralateral to the pain.
World Health Organization Quality of Life Abbreviated (WHOQOL-BREF) Overall pre-treatment baseline	5 score on a scale Interval 3.0 to 8.0
World Health Organization Quality of Life Abbreviated (WHOQOL-BREF) Overall 3 days post-treatment	5 score on a scale Interval 4.0 to 8.0
World Health Organization Quality of Life Abbreviated (WHOQOL-BREF) Overall 7 days post-treatment	5 score on a scale Interval 3.0 to 8.0

SECONDARY outcome

Timeframe: baseline, 3 and 7 days post treatment

Population: All enrolled patients

A questionnaire used to determine the impact and burden of a disease on daily life. This assessment has 26 questions and covers the domains of physical and psychological health, social relationships, and environment. The answers to various question are included in one or more of the domains. Raw scores are transformed in several different ways by different investigators. We report raw scores. Domains have the following raw score ranges: Overall Quality of Life 2-10, Physical Heath 7-35, Psychological Health 6-30, Social Relationships 3-15, Environment 8-40, Total Raw Score 26-130. Higher scores in each of the domains correspond to greater perceived quality of life.

Outcome measures

Outcome measures
Measure	Transcranial Magnetic Stimulation n=9 Participants transcranial magnetic stimulation transcranial magnetic stimulation: Treatment will consist of five daily sessions of transcranial magnetic stimulation of the motor cortex contralateral to the pain.
World Health Organization Quality of Life Abbreviated (WHOQOL-BREF) Physical Health baseline	19 score on a scale Interval 15.0 to 28.0
World Health Organization Quality of Life Abbreviated (WHOQOL-BREF) Physical Health 3 days post-treatment	18.5 score on a scale Interval 15.0 to 21.0
World Health Organization Quality of Life Abbreviated (WHOQOL-BREF) Physical Health 7 days post-treatment	17 score on a scale Interval 14.0 to 19.0

SECONDARY outcome

Timeframe: baseline, 3 and 7 days post treatment

Population: All enrolled patients

A questionnaire used to determine the impact and burden of a disease on daily life. This assessment has 26 questions and covers the domains of physical and psychological health, social relationships, and environment. The answers to various question are included in one or more of the domains. Raw scores are transformed in several different ways by different investigators. We report raw scores. Domains have the following raw score ranges: Overall Quality of Life 2-10, Physical Heath 7-35, Psychological Health 6-30, Social Relationships 3-15, Environment 8-40, Total Raw Score 26-130. Higher scores in each of the domains correspond to greater perceived quality of life.

Outcome measures

Outcome measures
Measure	Transcranial Magnetic Stimulation n=9 Participants transcranial magnetic stimulation transcranial magnetic stimulation: Treatment will consist of five daily sessions of transcranial magnetic stimulation of the motor cortex contralateral to the pain.
World Health Organization Quality of Life Abbreviated (WHOQOL-BREF) Psychological Health baseline	23 score on a scale Interval 17.0 to 28.0
World Health Organization Quality of Life Abbreviated (WHOQOL-BREF) Psychological Health 3 days post-treatment	22 score on a scale Interval 18.0 to 26.0
World Health Organization Quality of Life Abbreviated (WHOQOL-BREF) Psychological Health 7 days post-treatment	25 score on a scale Interval 12.0 to 27.0

SECONDARY outcome

Timeframe: baseline, 3 and 7 days post treatment

Population: All enrolled patients

A questionnaire used to determine the impact and burden of a disease on daily life. This assessment has 26 questions and covers the domains of physical and psychological health, social relationships, and environment. The answers to various question are included in one or more of the domains. Raw scores are transformed in several different ways by different investigators. We report raw scores. Domains have the following raw score ranges: Overall Quality of Life 2-10, Physical Heath 7-35, Psychological Health 6-30, Social Relationships 3-15, Environment 8-40, Total Raw Score 26-130. Higher scores in each of the domains correspond to greater perceived quality of life.

Outcome measures

Outcome measures
Measure	Transcranial Magnetic Stimulation n=9 Participants transcranial magnetic stimulation transcranial magnetic stimulation: Treatment will consist of five daily sessions of transcranial magnetic stimulation of the motor cortex contralateral to the pain.
World Health Organization Quality of Life Abbreviated (WHOQOL-BREF) Social Relationships baseline	13 score on a scale Interval 9.0 to 15.0
World Health Organization Quality of Life Abbreviated (WHOQOL-BREF) Social Relationships 3 days post-treatment	13 score on a scale Interval 9.0 to 15.0
World Health Organization Quality of Life Abbreviated (WHOQOL-BREF) Social Relationships 7 days post-treatment	13.5 score on a scale Interval 4.0 to 15.0

SECONDARY outcome

Timeframe: baseline, 3 and 7 days post treatment

Population: All enrolled patients

A questionnaire used to determine the impact and burden of a disease on daily life. This assessment has 26 questions and covers the domains of physical and psychological health, social relationships, and environment. The answers to various question are included in one or more of the domains. Raw scores are transformed in several different ways by different investigators. We report raw scores. Domains have the following raw score ranges: Overall Quality of Life 2-10, Physical Heath 7-35, Psychological Health 6-30, Social Relationships 3-15, Environment 8-40, Total Raw Score 26-130. Higher scores in each of the domains correspond to greater perceived quality of life.

Outcome measures

Outcome measures
Measure	Transcranial Magnetic Stimulation n=9 Participants transcranial magnetic stimulation transcranial magnetic stimulation: Treatment will consist of five daily sessions of transcranial magnetic stimulation of the motor cortex contralateral to the pain.
World Health Organization Quality of Life Abbreviated (WHOQOL-BREF) Environment baseline	37 score on a scale Interval 24.0 to 40.0
World Health Organization Quality of Life Abbreviated (WHOQOL-BREF) Environment 3 days post-treatment	37 score on a scale Interval 31.0 to 39.0
World Health Organization Quality of Life Abbreviated (WHOQOL-BREF) Environment 7 days post-treatment	38 score on a scale Interval 32.0 to 43.0

OTHER_PRE_SPECIFIED outcome

Timeframe: pre-treatment, 3 and 7 days post treatment

Population: all enrolled patients

The Young Mania Rating Scale (YMRS) is one of the most frequently utilized rating scales to assess manic symptoms. The scale has 11 items and is based on the patient's subjective report of his or her clinical condition over the previous 48 hours. The YMRS total score ranges from 0 to 60 where higher scores indicate more severe mania.

Outcome measures

Outcome measures
Measure	Transcranial Magnetic Stimulation n=9 Participants transcranial magnetic stimulation transcranial magnetic stimulation: Treatment will consist of five daily sessions of transcranial magnetic stimulation of the motor cortex contralateral to the pain.
Young Mania Rating Scale (YMRS) baseline	0 score on a scale Interval 0.0 to 2.0
Young Mania Rating Scale (YMRS) 3 days post treatment	0 score on a scale Interval 0.0 to 1.0
Young Mania Rating Scale (YMRS) 7 days post treatment	0 score on a scale Interval 0.0 to 1.0

Adverse Events

Transcranial Magnetic Stimulation

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Transcranial Magnetic Stimulation n=6 participants at risk transcranial magnetic stimulation transcranial magnetic stimulation: Treatment will consist of five daily sessions of transcranial magnetic stimulation of the motor cortex contralateral to the pain.
General disorders Increased Pain	16.7% 1/6 • Number of events 1 • 2 weeks
Nervous system disorders Tremors	16.7% 1/6 • Number of events 1 • 2 weeks
General disorders Fatigue	33.3% 2/6 • Number of events 2 • 2 weeks
General disorders Headache	16.7% 1/6 • Number of events 1 • 2 weeks
General disorders Non-specific Pain	16.7% 1/6 • Number of events 1 • 2 weeks

Additional Information

Stephen Haines, MD

University of Minenesota

Phone: 612 624-6666

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place