The Effectiveness of rTMS in Depressed VA Patients

• ClinicalTrials.gov Identifier: NCT01191333
• Recruitment Status: Completed
• First Posted: August 30, 2010
• Results First Posted: February 7, 2018
• Last Update Posted: March 9, 2018
• Sponsor: VA Office of Research and Development
• Information provided by (Responsible Party): VA Office of Research and Development

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Major Depressive Disorder
• Interventions: Device: rTMS; Device: Sham Device
• Enrollment: 164

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	Active rTMS	Sham rTMS
Arm/Group Description	Those receiving experimental treatment will receive 20 to 30 sessions of rTMS in blocks of 5 sessions. The treatment will be delivered by trained medical personnel. rTMS: Repetitive Transcranial Magnetic Stimulation	Those receiving the sham rTMS will receive 20 to 30 sessions of sham rTMS in blocks of 5 sessions. The treatment will be delivered by trained medical personnel. Sham Device: Placebo Device that simulates active rTMS treatment
Period Title: Overall Study
Started	81	83
Completed	60	65
Not Completed	21	18

Baseline Characteristics

Arm/Group Title		Active rTMS	Sham rTMS	Total
Arm/Group Description		Those receiving experimental treatment will receive 20 to 30 sessions of rTMS in blocks of 5 sessions. The treatment will be delivered by trained medical personnel. rTMS: Repetitive Transcranial Magnetic Stimulation	Those receiving the sham rTMS will receive 20 to 30 sessions of sham rTMS in blocks of 5 sessions. The treatment will be delivered by trained medical personnel. Sham Device: Placebo Device that simulates active rTMS treatment	Total of all reporting groups
Overall Number of Baseline Participants		81	83	164
Baseline Analysis Population Description		[Not Specified]
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	81 participants	83 participants	164 participants
		55.6 (12.2)	54.8 (12.6)	55.2 (12.4)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	81 participants	83 participants	164 participants
	Female	14 17.3%	18 21.7%	32 19.5%
	Male	67 82.7%	65 78.3%	132 80.5%
Race (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	81 participants	83 participants	164 participants
	American Indian or Alaska Native	2 2.5%	0 0.0%	2 1.2%
	Asian	1 1.2%	3 3.6%	4 2.4%
	Native Hawaiian or Other Pacific Islander	0 0.0%	0 0.0%	0 0.0%
	Black or African American	12 14.8%	14 16.9%	26 15.9%
	White	63 77.8%	63 75.9%	126 76.8%
	More than one race	3 3.7%	2 2.4%	5 3.0%
	Unknown or Not Reported	0 0.0%	1 1.2%	1 0.6%
Region of Enrollment; Measure Type: Count of Participants; Unit of measure: Participants
United States	Number Analyzed	81 participants	83 participants	164 participants
		81 100.0%	83 100.0%	164 100.0%
Beck Scale for Suicide Ideation (BSI) [1] [2]; Mean (Standard Deviation); Unit of measure: Units on a scale
	Number Analyzed	77 participants	82 participants	159 participants
		3.7 (6.0)	5.6 (6.7)	4.7 (6.5)
		[1] Measure Description: This self-report measure consists of 21 items with overall score range from 0 - 38, with the last two items not counted in scoring. A high score represents a worse outcome.; [2] Measure Analysis Population Description: Missing values
Beck Depression Inventory (BDI) [1] [2]; Mean (Standard Deviation); Unit of measure: Units on a scale
	Number Analyzed	78 participants	77 participants	155 participants
		22.6 (10.3)	26.5 (10.0)	24.5 (10.3)
		[1] Measure Description: This measure is a 21-item self-report test presented in a multiple choice format which measures presence and extent of depression with overall score range from 0 - 63. A higher score represents a worse outcome.; [2] Measure Analysis Population Description: Missing values
VR-36 Mental Component Summary (MCS) [1] [2]; Mean (Standard Deviation); Unit of measure: Units on a scale
	Number Analyzed	81 participants	82 participants	163 participants
		27.2 (11.6)	25.1 (10.0)	26.2 (10.8)
		[1] Measure Description: Standardized scoring ranging from 0-100. A higher score represents a better outcome; [2] Measure Analysis Population Description: Missing value
VR-36 Physical Component Summary (PCS) [1] [2]; Mean (Standard Deviation); Unit of measure: Units on a scale
	Number Analyzed	81 participants	82 participants	163 participants
		42.4 (11.5)	40.2 (10.0)	41.3 (10.8)
		[1] Measure Description: Standardized scoring ranging from 0-100. A higher score represents a better outcome; [2] Measure Analysis Population Description: Missing value
Montgomery Asberg Depression Rating Scale (MADRS) [1]; Mean (Standard Deviation); Unit of measure: Units on a scale
	Number Analyzed	81 participants	83 participants	164 participants
		24.7 (7.6)	26.2 (6.9)	25.5 (7.3)
		[1] Measure Description: As another measure of depression, the Montgomery-Asberg Depression Rating Scale (MADRS) has been used with increasing frequency in recent years to measure outcome in antidepressant efficacy trials. It offers an alternative view of depressive illness, and may be sensitive to depressive symptoms that are not easily captured in the context of the HRSD, such as hypersomnia, increased appetite, and concentration/indecision. The MADRS is a 10-item clinician rating of depressive symptoms. Each item is scored on a 7-point scale (0 to 6) (range 0-60).

Outcome Measures

1. Primary Outcome

Title	The Proportion of Participants Achieving Remission From Depression as Assessed by Hamilton Rating Scale for Depression
Description	The primary outcome is a proportion of participants achieving remission from depression based on the HRSD24 less than or equal to 10 at the end of the acute treatment phase. 24 item Instrument with overall score range from 0 - 76. High values represent a worse outcome.
Time Frame	End of acute treatment 4-6 weeks

Outcome Measure Data

Analysis Population Description

ITT

Arm/Group Title	Active rTMS	Sham rTMS
Arm/Group Description:	Those receiving experimental treatment will receive 20 to 30 sessions of rTMS in blocks of 5 sessions. The treatment will be delivered by trained medical personnel. rTMS: Repetitive Transcranial Magnetic Stimulation	Those receiving the sham rTMS will receive 20 to 30 sessions of sham rTMS in blocks of 5 sessions. The treatment will be delivered by trained medical personnel. Sham Device: Placebo Device that simulates active rTMS treatment
Overall Number of Participants Analyzed	81	83
Measure Type: Count of Participants; Unit of Measure: Participants
	33 40.7%	31 37.3%

2. Secondary Outcome

Title	Mean Suicidal Ideation Score as Assessed by Beck Scale for Suicide Ideation (BSS)
Description	To help clinicians screen psychiatric patients for suicidal ideation, the Beck Scale for Suicide Ideation was developed, and is herein referred to as the BSS. This self-report measure consists of 21 items with overall score range from 0 - 38, with the last two items not counted in scoring. A high score represents a worse outcome.
Time Frame	End of acute treatment 4-6 weeks, then end of F/U 6 months

Outcome Measure Data

Analysis Population Description

ITT minus participants with missing values

Arm/Group Title	Active rTMS	Sham rTMS
Arm/Group Description:	Those receiving experimental treatment will receive 20 to 30 sessions of rTMS in blocks of 5 sessions. The treatment will be delivered by trained medical personnel. rTMS: Repetitive Transcranial Magnetic Stimulation	Those receiving the sham rTMS will receive 20 to 30 sessions of sham rTMS in blocks of 5 sessions. The treatment will be delivered by trained medical personnel. Sham Device: Placebo Device that simulates active rTMS treatment
Overall Number of Participants Analyzed	67	72
Mean (Standard Deviation); Unit of Measure: units on a scale
End of Acute Treatment	2.0 (4.6)	2.7 (4.9)
End of F/U	1.5 (4.2)	2.5 (4.9)

3. Secondary Outcome

Title	Mean Depression Score as Assessed by Beck Depression Inventory (BDI)
Description	This measure is a 21-item self-report test presented in a multiple choice format which measures presence and extent of depression with overall score range from 0 - 63. A higher score represents a worse outcome. Each of the 21 items addresses a specific symptom or attitude that pertains to depressed patients, and which are consistent with descriptions of the depression within the peer-reviewed literature. While generally deemed less reliable than scales score by a trained rater (for example, the HRSD), the Beck scale is easy to administer, and provides convenient means by which patients can effectively communicate their own perception of their mood state.
Time Frame	Baseline - end of acute treatment 4-6 weeks, then end of F/U 6 months

Outcome Measure Data

Analysis Population Description

ITT minus participants with missing values

Arm/Group Title	Active rTMS	Sham rTMS
Arm/Group Description:	Those receiving experimental treatment will receive 20 to 30 sessions of rTMS in blocks of 5 sessions. The treatment will be delivered by trained medical personnel. rTMS: Repetitive Transcranial Magnetic Stimulation	Those receiving the sham rTMS will receive 20 to 30 sessions of sham rTMS in blocks of 5 sessions. The treatment will be delivered by trained medical personnel. Sham Device: Placebo Device that simulates active rTMS treatment
Overall Number of Participants Analyzed	66	72
Mean (Standard Deviation); Unit of Measure: units on a scale
End of Acute Treatment	14.2 (10.9)	13.0 (9.5)
End of F/U	9.0 (8.3)	12.8 (10.8)

4. Secondary Outcome

Title	Mean Mental Component Score as Assessed by VR-36 Mental Component Summary (MCS)
Description	The VR-36 is a self-administered survey that measures eight dimensions of health: physical functioning, role limitations due to physical health, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems, and mental health. It yields scale scores for each of these eight health domains, and two summary measures of physical and mental health: the Physical Component Summary (PCS) and Mental Component Summary (MCS). MCS is analyzed in this section. Standardized scoring ranging from 0-100. A higher score represents a better outcome.
Time Frame	End of acute treatment 4-6 weeks, then end of F/U 6 months

Outcome Measure Data

Analysis Population Description

ITT minus participants with missing values

Arm/Group Title	Active rTMS	Sham rTMS
Arm/Group Description:	Those receiving experimental treatment will receive 20 to 30 sessions of rTMS in blocks of 5 sessions. The treatment will be delivered by trained medical personnel. rTMS: Repetitive Transcranial Magnetic Stimulation	Those receiving the sham rTMS will receive 20 to 30 sessions of sham rTMS in blocks of 5 sessions. The treatment will be delivered by trained medical personnel. Sham Device: Placebo Device that simulates active rTMS treatment
Overall Number of Participants Analyzed	68	73
Mean (Standard Deviation); Unit of Measure: units on a scale
End of Acute Treatment	35.1 (14.3)	36.0 (14.7)
End of F/U	34.5 (12.8)	34.8 (13.4)

5. Secondary Outcome

Title	Mean Physical Component Score as Assessed by VR-36 Physical Component Summary (PCS)
Description	The VR-36 is a self-administered survey that measures eight dimensions of health: physical functioning, role limitations due to physical health, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems, and mental health. It yields scale scores for each of these eight health domains, and two summary measures of physical and mental health: the Physical Component Summary (PCS) and Mental Component Summary (MCS). PCS is analyzed in this section. Standardized scoring ranging from 0-100. A higher score represents a better outcome.
Time Frame	End of acute treatment 4-6 weeks, then end of F/U 6 months

Outcome Measure Data

Analysis Population Description

ITT minus participants with missing values

Arm/Group Title	Active rTMS	Sham rTMS
Arm/Group Description:	Those receiving experimental treatment will receive 20 to 30 sessions of rTMS in blocks of 5 sessions. The treatment will be delivered by trained medical personnel. rTMS: Repetitive Transcranial Magnetic Stimulation	Those receiving the sham rTMS will receive 20 to 30 sessions of sham rTMS in blocks of 5 sessions. The treatment will be delivered by trained medical personnel. Sham Device: Placebo Device that simulates active rTMS treatment
Overall Number of Participants Analyzed	68	73
Mean (Standard Deviation); Unit of Measure: units on a scale
End of Acute Treatment	41.9 (10.9)	41.2 (11.9)
End of F/U	42.8 (10.8)	40.1 (12.3)

6. Secondary Outcome

Title	Mean Depression Score as Assessed by the Montgomery Asberg Depression Rating Scale (MADRS)
Description	As another measure of depression, the Montgomery-Asberg Depression Rating Scale (MADRS) has been used with increasing frequency in recent years to measure outcome in antidepressant efficacy trials. It offers an alternative view of depressive illness, and may be sensitive to depressive symptoms that are not easily captured in the context of the HRSD, such as hypersomnia, increased appetite, and concentration/indecision. The MADRS is a 10-item clinician rating of depressive symptoms. Each item is scored on a 7-point scale (0 to 6) (range 0-60). A high score represents a worse outcome.
Time Frame	End of acute treatment 4-6 weeks, then end of F/U 6 months

Outcome Measure Data

Analysis Population Description

ITT minus participants with missing values

Arm/Group Title	Active rTMS	Sham rTMS
Arm/Group Description:	Those receiving experimental treatment will receive 20 to 30 sessions of rTMS in blocks of 5 sessions. The treatment will be delivered by trained medical personnel. rTMS: Repetitive Transcranial Magnetic Stimulation	Those receiving the sham rTMS will receive 20 to 30 sessions of sham rTMS in blocks of 5 sessions. The treatment will be delivered by trained medical personnel. Sham Device: Placebo Device that simulates active rTMS treatment
Overall Number of Participants Analyzed	70	74
Mean (Standard Deviation); Unit of Measure: units on a scale
End of Acute Treatment	14.3 (11.1)	13.1 (10.5)
End of F/U	13.7 (10.2)	15.0 (9.7)

Adverse Events

Time Frame	From informed consent until termination. 7-8 months.
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	Active rTMS		Sham rTMS
Arm/Group Description	Those receiving experimental treatment will receive 20 to 30 sessions of rTMS in blocks of 5 sessions. The treatment will be delivered by trained medical personnel. rTMS: Repetitive Transcranial Magnetic Stimulation		Those receiving the sham rTMS will receive 20 to 30 sessions of sham rTMS in blocks of 5 sessions. The treatment will be delivered by trained medical personnel. Sham Device: Placebo Device that simulates active rTMS treatment
All-Cause Mortality
	Active rTMS		Sham rTMS
	Affected / at Risk (%)		Affected / at Risk (%)
Total	0/81 (0.00%)		0/83 (0.00%)
Serious Adverse Events
	Active rTMS		Sham rTMS
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	22/81 (27.16%)		18/83 (21.69%)
Cardiac disorders
Arrhythmia † 1	0/81 (0.00%)	0	1/83 (1.20%)	1
Coronary artery disease † 1	0/81 (0.00%)	0	1/83 (1.20%)	1
Ear and labyrinth disorders
Hypoacusis † 1	2/81 (2.47%)	2	2/83 (2.41%)	2
Gastrointestinal disorders
Pancreatitis † 1	1/81 (1.23%)	2	0/83 (0.00%)	0
General disorders
Chest discomfort † 1	1/81 (1.23%)	1	0/83 (0.00%)	0
Chest pain † 1	0/81 (0.00%)	0	1/83 (1.20%)	1
Drug withdrawal syndrome † 1	0/81 (0.00%)	0	1/83 (1.20%)	1
Hernia † 1	1/81 (1.23%)	1	0/83 (0.00%)	0
Hepatobiliary disorders
Gallbladder disorder † 1	1/81 (1.23%)	1	0/83 (0.00%)	0
Immune system disorders
Allergy to arthropod sting † 1	1/81 (1.23%)	1	0/83 (0.00%)	0
Infections and infestations
Gastroenteritis viral † 1	0/81 (0.00%)	0	1/83 (1.20%)	1
Orchitis † 1	0/81 (0.00%)	0	1/83 (1.20%)	1
Staphylococcal infection † 1	1/81 (1.23%)	1	0/83 (0.00%)	0
Viral infection † 1	0/81 (0.00%)	0	1/83 (1.20%)	1
Injury, poisoning and procedural complications
Alcohol poisoning † 1	2/81 (2.47%)	2	0/83 (0.00%)	0
Accidental overdose † 1	0/81 (0.00%)	0	1/83 (1.20%)	1
Fall † 1	0/81 (0.00%)	0	1/83 (1.20%)	1
Road traffic accident † 1	1/81 (1.23%)	1	0/83 (0.00%)	0
Investigations
Acoustic stimulation tests abnormal † 1	4/81 (4.94%)	4	5/83 (6.02%)	5
Metabolism and nutrition disorders
Hyperglycaemia † 1	0/81 (0.00%)	0	1/83 (1.20%)	1
Musculoskeletal and connective tissue disorders
Arthralgia † 1	1/81 (1.23%)	1	0/83 (0.00%)	0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Clear cell renal cell carcinoma † 1	0/81 (0.00%)	0	1/83 (1.20%)	1
Nervous system disorders
Transient ischaemic attack † 1	0/81 (0.00%)	0	1/83 (1.20%)	1
Psychiatric disorders
Suicidal ideation † 1	4/81 (4.94%)	4	4/83 (4.82%)	4
Depression † 1	1/81 (1.23%)	1	2/83 (2.41%)	2
Suicide attempt † 1	1/81 (1.23%)	1	1/83 (1.20%)	1
Anxiety † 1	0/81 (0.00%)	0	1/83 (1.20%)	1
Depressed mood † 1	1/81 (1.23%)	1	0/83 (0.00%)	0
Depression suicidal † 1	0/81 (0.00%)	0	1/83 (1.20%)	1
Mania † 1	1/81 (1.23%)	1	0/83 (0.00%)	0
Obsessive-compulsive disorder † 1	0/81 (0.00%)	0	1/83 (1.20%)	1
Persistent depressive disorder † 1	1/81 (1.23%)	1	0/83 (0.00%)	0
Post-traumatic stress disorder † 1	0/81 (0.00%)	0	1/83 (1.20%)	1
Respiratory, thoracic and mediastinal disorders
Pleuritic pain † 1	1/81 (1.23%)	1	0/83 (0.00%)	0
Pulmonary embolism † 1	0/81 (0.00%)	0	1/83 (1.20%)	1
Vascular disorders
Hypotension † 1	1/81 (1.23%)	1	0/83 (0.00%)	0
1 Term from vocabulary, MedDRA (10.0); † Indicates events were collected by systematic assessment
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	Active rTMS		Sham rTMS
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	71/81 (87.65%)		69/83 (83.13%)
Blood and lymphatic system disorders
Lymphadenopathy † 1	0/81 (0.00%)	0	1/83 (1.20%)	1
Cardiac disorders
Arrhythmia † 1	0/81 (0.00%)	0	1/83 (1.20%)	1
Congenital, familial and genetic disorders
Arnold-Chiari malformation † 1	1/81 (1.23%)	3	0/83 (0.00%)	0
Ear and labyrinth disorders
Hypoacusis † 1	1/81 (1.23%)	1	4/83 (4.82%)	4
Tinnitus † 1	1/81 (1.23%)	1	2/83 (2.41%)	3
Ear pain † 1	1/81 (1.23%)	1	2/83 (2.41%)	2
Vertigo † 1	1/81 (1.23%)	1	2/83 (2.41%)	2
Deafness neurosensory † 1	0/81 (0.00%)	0	1/83 (1.20%)	1
Endocrine disorders
Thyroid mass † 1	1/81 (1.23%)	1	0/83 (0.00%)	0
Eye disorders
Vision blurred † 1	3/81 (3.70%)	3	0/83 (0.00%)	0
Blindness † 1	1/81 (1.23%)	1	0/83 (0.00%)	0
Conjunctivitis allergic † 1	1/81 (1.23%)	1	0/83 (0.00%)	0
Diabetic retinopathy † 1	0/81 (0.00%)	0	1/83 (1.20%)	1
Episcleritis † 1	1/81 (1.23%)	1	0/83 (0.00%)	0
Glaucoma † 1	1/81 (1.23%)	1	0/83 (0.00%)	0
Photophobia † 1	0/81 (0.00%)	0	1/83 (1.20%)	1
Photopsia † 1	0/81 (0.00%)	0	1/83 (1.20%)	1
Visual impairment † 1	1/81 (1.23%)	1	0/83 (0.00%)	0
Gastrointestinal disorders
Toothache † 1	3/81 (3.70%)	3	2/83 (2.41%)	2
Abdominal discomfort † 1	1/81 (1.23%)	1	3/83 (3.61%)	3
Diarrhoea † 1	1/81 (1.23%)	1	2/83 (2.41%)	2
Gastrooesophageal reflux disease † 1	1/81 (1.23%)	1	2/83 (2.41%)	2
Abdominal pain † 1	0/81 (0.00%)	0	2/83 (2.41%)	2
Constipation † 1	2/81 (2.47%)	2	0/83 (0.00%)	0
Dental caries † 1	0/81 (0.00%)	0	2/83 (2.41%)	2
Dyspepsia † 1	0/81 (0.00%)	0	2/83 (2.41%)	2
Nausea † 1	1/81 (1.23%)	1	1/83 (1.20%)	1
Vomiting † 1	0/81 (0.00%)	0	2/83 (2.41%)	2
Abdominal distension † 1	0/81 (0.00%)	0	1/83 (1.20%)	1
Abdominal hernia † 1	1/81 (1.23%)	1	0/83 (0.00%)	0
Anal fistula † 1	1/81 (1.23%)	1	0/83 (0.00%)	0
Aphthous ulcer † 1	1/81 (1.23%)	1	0/83 (0.00%)	0
Diverticulum intestinal † 1	1/81 (1.23%)	1	0/83 (0.00%)	0
Flatulence † 1	0/81 (0.00%)	0	1/83 (1.20%)	1
Gastrointestinal disorder † 1	0/81 (0.00%)	0	1/83 (1.20%)	1
Gastrointestinal pain † 1	0/81 (0.00%)	0	1/83 (1.20%)	1
Inguinal hernia † 1	1/81 (1.23%)	1	0/83 (0.00%)	0
Oesophageal achalasia † 1	0/81 (0.00%)	0	1/83 (1.20%)	1
Retching † 1	0/81 (0.00%)	0	1/83 (1.20%)	1
Umbilical hernia † 1	0/81 (0.00%)	0	1/83 (1.20%)	1
General disorders
Pain † 1	3/81 (3.70%)	3	4/83 (4.82%)	4
Adverse drug reaction † 1	2/81 (2.47%)	2	2/83 (2.41%)	2
Chest pain † 1	3/81 (3.70%)	3	1/83 (1.20%)	1
Fatigue † 1	2/81 (2.47%)	2	1/83 (1.20%)	1
Influenza like illness † 1	2/81 (2.47%)	2	0/83 (0.00%)	0
Pyrexia † 1	1/81 (1.23%)	1	1/83 (1.20%)	1
Drug withdrawal syndrome † 1	1/81 (1.23%)	1	0/83 (0.00%)	0
Nodule † 1	0/81 (0.00%)	0	1/83 (1.20%)	1
Sensation of blood flow † 1	0/81 (0.00%)	0	1/83 (1.20%)	1
Sensation of foreign body † 1	1/81 (1.23%)	1	0/83 (0.00%)	0
Swelling † 1	0/81 (0.00%)	0	1/83 (1.20%)	1
Ulcer † 1	1/81 (1.23%)	1	0/83 (0.00%)	0
Hepatobiliary disorders
Biliary dyskinesia † 1	1/81 (1.23%)	1	0/83 (0.00%)	0
Hepatocellular injury † 1	0/81 (0.00%)	0	1/83 (1.20%)	1
Immune system disorders
Seasonal allergy † 1	1/81 (1.23%)	1	2/83 (2.41%)	2
Hypersensitivity † 1	1/81 (1.23%)	1	1/83 (1.20%)	1
Infections and infestations
Nasopharyngitis † 1	8/81 (9.88%)	8	8/83 (9.64%)	12
Upper respiratory tract infection † 1	4/81 (4.94%)	4	4/83 (4.82%)	5
Gastroenteritis † 1	4/81 (4.94%)	5	1/83 (1.20%)	1
Sinusitis † 1	1/81 (1.23%)	2	3/83 (3.61%)	3
Influenza † 1	1/81 (1.23%)	2	2/83 (2.41%)	2
Bronchitis † 1	2/81 (2.47%)	2	1/83 (1.20%)	1
Carbuncle † 1	0/81 (0.00%)	0	2/83 (2.41%)	3
Cellulitis † 1	1/81 (1.23%)	1	2/83 (2.41%)	2
Tooth abscess † 1	2/81 (2.47%)	2	1/83 (1.20%)	1
Urinary tract infection † 1	0/81 (0.00%)	0	3/83 (3.61%)	3
Epididymitis † 1	1/81 (1.23%)	2	0/83 (0.00%)	0
Pilonidal cyst † 1	1/81 (1.23%)	1	1/83 (1.20%)	1
Bacterial infection † 1	0/81 (0.00%)	0	1/83 (1.20%)	1
Conjunctivitis † 1	0/81 (0.00%)	0	1/83 (1.20%)	1
Folliculitis † 1	1/81 (1.23%)	1	0/83 (0.00%)	0
Furuncle † 1	0/81 (0.00%)	0	1/83 (1.20%)	1
Hordeolum † 1	1/81 (1.23%)	1	0/83 (0.00%)	0
Infection † 1	1/81 (1.23%)	1	0/83 (0.00%)	0
Laryngitis † 1	1/81 (1.23%)	1	0/83 (0.00%)	0
Oral bacterial infection † 1	0/81 (0.00%)	0	1/83 (1.20%)	1
Oral herpes † 1	0/81 (0.00%)	0	1/83 (1.20%)	1
Pharyngitis streptococcal † 1	0/81 (0.00%)	0	1/83 (1.20%)	1
Pneumonia † 1	0/81 (0.00%)	0	1/83 (1.20%)	1
Respiratory tract infection † 1	1/81 (1.23%)	1	0/83 (0.00%)	0
Skin infection † 1	1/81 (1.23%)	1	0/83 (0.00%)	0
Tooth infection † 1	0/81 (0.00%)	0	1/83 (1.20%)	1
Vaginitis gardnerella † 1	0/81 (0.00%)	0	1/83 (1.20%)	1
Viral infection † 1	0/81 (0.00%)	0	1/83 (1.20%)	1
Viral upper respiratory tract infection † 1	0/81 (0.00%)	0	1/83 (1.20%)	1
Injury, poisoning and procedural complications
Fall † 1	3/81 (3.70%)	4	6/83 (7.23%)	6
Animal bite † 1	0/81 (0.00%)	0	2/83 (2.41%)	3
Limb injury † 1	1/81 (1.23%)	1	2/83 (2.41%)	2
Exposure to toxic agent † 1	1/81 (1.23%)	2	0/83 (0.00%)	0
Ligament sprain † 1	1/81 (1.23%)	1	1/83 (1.20%)	1
Road traffic accident † 1	1/81 (1.23%)	1	1/83 (1.20%)	1
Animal scratch † 1	0/81 (0.00%)	0	1/83 (1.20%)	1
Arthropod bite † 1	0/81 (0.00%)	0	1/83 (1.20%)	1
Arthropod sting † 1	1/81 (1.23%)	1	0/83 (0.00%)	0
Contusion † 1	1/81 (1.23%)	1	0/83 (0.00%)	0
Ear canal abrasion † 1	1/81 (1.23%)	1	0/83 (0.00%)	0
Fibula fracture † 1	1/81 (1.23%)	1	0/83 (0.00%)	0
Foot fracture † 1	0/81 (0.00%)	0	1/83 (1.20%)	1
Incorrect dosage administered † 1	0/81 (0.00%)	0	1/83 (1.20%)	1
Laceration † 1	0/81 (0.00%)	0	1/83 (1.20%)	1
Muscle strain † 1	0/81 (0.00%)	0	1/83 (1.20%)	1
Penis injury † 1	0/81 (0.00%)	0	1/83 (1.20%)	1
Post-traumatic neck syndrome † 1	1/81 (1.23%)	1	0/83 (0.00%)	0
Stoma obstruction † 1	0/81 (0.00%)	0	1/83 (1.20%)	1
Tooth injury † 1	0/81 (0.00%)	0	1/83 (1.20%)	1
Upper limb fracture † 1	1/81 (1.23%)	1	0/83 (0.00%)	0
Wound † 1	1/81 (1.23%)	1	0/83 (0.00%)	0
Investigations
Acoustic stimulation tests abnormal † 1	16/81 (19.75%)	18	16/83 (19.28%)	19
Colonoscopy † 1	2/81 (2.47%)	2	0/83 (0.00%)	0
Alanine aminotransferase increased † 1	0/81 (0.00%)	0	1/83 (1.20%)	1
Blood thyroid stimulating hormone increased † 1	1/81 (1.23%)	1	0/83 (0.00%)	0
Ejection fraction decreased † 1	0/81 (0.00%)	0	1/83 (1.20%)	1
Hepatic enzyme increased † 1	1/81 (1.23%)	1	0/83 (0.00%)	0
Protein total decreased † 1	1/81 (1.23%)	1	0/83 (0.00%)	0
Metabolism and nutrition disorders
Hypoglycaemia † 1	1/81 (1.23%)	1	2/83 (2.41%)	2
Dehydration † 1	0/81 (0.00%)	0	2/83 (2.41%)	2
Gout † 1	2/81 (2.47%)	2	0/83 (0.00%)	0
Diabetes mellitus inadequate control † 1	0/81 (0.00%)	0	1/83 (1.20%)	1
Musculoskeletal and connective tissue disorders
Muscle spasms † 1	2/81 (2.47%)	2	4/83 (4.82%)	5
Arthralgia † 1	4/81 (4.94%)	4	2/83 (2.41%)	2
Back pain † 1	2/81 (2.47%)	2	4/83 (4.82%)	4
Arthritis † 1	2/81 (2.47%)	2	1/83 (1.20%)	1
Muscle twitching † 1	1/81 (1.23%)	1	2/83 (2.41%)	2
Pain in extremity † 1	0/81 (0.00%)	0	3/83 (3.61%)	3
Trigger finger † 1	1/81 (1.23%)	1	2/83 (2.41%)	2
Exostosis † 1	1/81 (1.23%)	1	1/83 (1.20%)	1
Flank pain † 1	1/81 (1.23%)	1	1/83 (1.20%)	1
Musculoskeletal pain † 1	2/81 (2.47%)	2	0/83 (0.00%)	0
Rotator cuff syndrome † 1	2/81 (2.47%)	2	0/83 (0.00%)	0
Bursitis † 1	0/81 (0.00%)	0	1/83 (1.20%)	1
Cervical spinal stenosis † 1	1/81 (1.23%)	1	0/83 (0.00%)	0
Chest wall mass † 1	1/81 (1.23%)	1	0/83 (0.00%)	0
Intervertebral disc degeneration † 1	0/81 (0.00%)	0	1/83 (1.20%)	1
Joint effusion † 1	0/81 (0.00%)	0	1/83 (1.20%)	1
Musculoskeletal chest pain † 1	0/81 (0.00%)	0	1/83 (1.20%)	1
Myalgia † 1	1/81 (1.23%)	1	0/83 (0.00%)	0
Neck pain † 1	1/81 (1.23%)	1	0/83 (0.00%)	0
Osteoarthritis † 1	0/81 (0.00%)	0	1/83 (1.20%)	1
Rhabdomyolysis † 1	1/81 (1.23%)	1	0/83 (0.00%)	0
Spinal osteoarthritis † 1	0/81 (0.00%)	0	1/83 (1.20%)	1
Synovial cyst † 1	1/81 (1.23%)	1	0/83 (0.00%)	0
Temporomandibular joint syndrome † 1	0/81 (0.00%)	0	1/83 (1.20%)	1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma in situ † 1	0/81 (0.00%)	0	1/83 (1.20%)	1
Pituitary tumour benign † 1	1/81 (1.23%)	1	0/83 (0.00%)	0
Skin cancer † 1	1/81 (1.23%)	1	0/83 (0.00%)	0
Nervous system disorders
Headache † 1	15/81 (18.52%)	25	16/83 (19.28%)	25
Dizziness † 1	2/81 (2.47%)	2	3/83 (3.61%)	3
Balance disorder † 1	0/81 (0.00%)	0	2/83 (2.41%)	2
Sinus headache † 1	1/81 (1.23%)	1	1/83 (1.20%)	1
Ataxia † 1	1/81 (1.23%)	1	0/83 (0.00%)	0
Facial paralysis † 1	0/81 (0.00%)	0	1/83 (1.20%)	1
Hypoaesthesia † 1	0/81 (0.00%)	0	1/83 (1.20%)	1
Loss of consciousness † 1	1/81 (1.23%)	1	0/83 (0.00%)	0
Memory impairment † 1	0/81 (0.00%)	0	1/83 (1.20%)	1
Migraine † 1	0/81 (0.00%)	0	1/83 (1.20%)	1
Mononeuropathy † 1	1/81 (1.23%)	1	0/83 (0.00%)	0
Paraesthesia † 1	1/81 (1.23%)	1	0/83 (0.00%)	0
Phantom pain † 1	1/81 (1.23%)	1	0/83 (0.00%)	0
Radiculopathy † 1	1/81 (1.23%)	1	0/83 (0.00%)	0
Sensory disturbance † 1	0/81 (0.00%)	0	1/83 (1.20%)	1
Speech disorder † 1	1/81 (1.23%)	1	0/83 (0.00%)	0
Syncope † 1	0/81 (0.00%)	0	1/83 (1.20%)	1
Tension headache † 1	0/81 (0.00%)	0	1/83 (1.20%)	1
Tremor † 1	1/81 (1.23%)	1	0/83 (0.00%)	0
Visual field defect † 1	1/81 (1.23%)	1	0/83 (0.00%)	0
Psychiatric disorders
Depression † 1	6/81 (7.41%)	7	2/83 (2.41%)	2
Anxiety † 1	4/81 (4.94%)	4	2/83 (2.41%)	2
Insomnia † 1	3/81 (3.70%)	3	1/83 (1.20%)	1
Agitated depression † 1	0/81 (0.00%)	0	1/83 (1.20%)	1
Bipolar disorder † 1	1/81 (1.23%)	1	0/83 (0.00%)	0
Confusional state † 1	0/81 (0.00%)	0	1/83 (1.20%)	1
Derealisation † 1	1/81 (1.23%)	1	0/83 (0.00%)	0
Dissociation † 1	1/81 (1.23%)	1	0/83 (0.00%)	0
Flashback † 1	1/81 (1.23%)	1	0/83 (0.00%)	0
Mood altered † 1	1/81 (1.23%)	1	0/83 (0.00%)	0
Panic attack † 1	1/81 (1.23%)	1	0/83 (0.00%)	0
Parasomnia † 1	1/81 (1.23%)	1	0/83 (0.00%)	0
Post-traumatic stress disorder † 1	0/81 (0.00%)	0	1/83 (1.20%)	1
Suicidal ideation † 1	0/81 (0.00%)	0	1/83 (1.20%)	1
Renal and urinary disorders
Incontinence † 1	2/81 (2.47%)	3	0/83 (0.00%)	0
Dysuria † 1	1/81 (1.23%)	1	1/83 (1.20%)	1
Urinary retention † 1	1/81 (1.23%)	1	1/83 (1.20%)	1
Acute kidney injury † 1	1/81 (1.23%)	1	0/83 (0.00%)	0
Nephrolithiasis † 1	0/81 (0.00%)	0	1/83 (1.20%)	1
Urinary incontinence † 1	1/81 (1.23%)	1	0/83 (0.00%)	0
Urinary tract obstruction † 1	1/81 (1.23%)	1	0/83 (0.00%)	0
Reproductive system and breast disorders
Erectile dysfunction † 1	0/81 (0.00%)	0	1/83 (1.20%)	1
Respiratory, thoracic and mediastinal disorders
Dyspnoea † 1	1/81 (1.23%)	1	1/83 (1.20%)	1
Epistaxis † 1	1/81 (1.23%)	1	1/83 (1.20%)	1
Oropharyngeal pain † 1	2/81 (2.47%)	2	0/83 (0.00%)	0
Sleep apnoea syndrome † 1	2/81 (2.47%)	2	0/83 (0.00%)	0
Chronic obstructive pulmonary disease † 1	1/81 (1.23%)	1	0/83 (0.00%)	0
Cough † 1	1/81 (1.23%)	1	0/83 (0.00%)	0
Haemoptysis † 1	0/81 (0.00%)	0	1/83 (1.20%)	1
Hiccups † 1	0/81 (0.00%)	0	1/83 (1.20%)	1
Nasal congestion † 1	1/81 (1.23%)	1	0/83 (0.00%)	0
Respiratory tract congestion † 1	0/81 (0.00%)	0	1/83 (1.20%)	1
Rhinorrhoea † 1	0/81 (0.00%)	0	1/83 (1.20%)	1
Skin and subcutaneous tissue disorders
Rash † 1	1/81 (1.23%)	1	1/83 (1.20%)	1
Urticaria † 1	1/81 (1.23%)	2	0/83 (0.00%)	0
Dermatitis contact † 1	1/81 (1.23%)	1	0/83 (0.00%)	0
Ecchymosis † 1	1/81 (1.23%)	1	0/83 (0.00%)	0
Eczema † 1	1/81 (1.23%)	1	0/83 (0.00%)	0
Ingrowing nail † 1	1/81 (1.23%)	1	0/83 (0.00%)	0
Pain of skin † 1	1/81 (1.23%)	1	0/83 (0.00%)	0
Rash pruritic † 1	1/81 (1.23%)	1	0/83 (0.00%)	0
Skin discolouration † 1	0/81 (0.00%)	0	1/83 (1.20%)	1
Skin discomfort † 1	1/81 (1.23%)	1	0/83 (0.00%)	0
Skin reaction † 1	0/81 (0.00%)	0	1/83 (1.20%)	1
Skin ulcer † 1	1/81 (1.23%)	1	0/83 (0.00%)	0
Surgical and medical procedures
Tooth extraction † 1	1/81 (1.23%)	1	1/83 (1.20%)	1
Dental care † 1	1/81 (1.23%)	1	0/83 (0.00%)	0
Elective procedure † 1	0/81 (0.00%)	0	1/83 (1.20%)	1
Papilloma excision † 1	1/81 (1.23%)	1	0/83 (0.00%)	0
Shoulder operation † 1	1/81 (1.23%)	1	0/83 (0.00%)	0
Vascular disorders
Deep vein thrombosis † 1	0/81 (0.00%)	0	1/83 (1.20%)	1
Hypertension † 1	0/81 (0.00%)	0	1/83 (1.20%)	1
Lymphoedema † 1	0/81 (0.00%)	0	1/83 (1.20%)	1
Orthostatic hypotension † 1	1/81 (1.23%)	1	0/83 (0.00%)	0
1 Term from vocabulary, MedDRA (10.0); † Indicates events were collected by systematic assessment

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

Results Point of Contact

• Name/Title: Jerome Yesavage, MD
• Organization: Director, VISN21 MIRECC, Department of Veterans Affairs
• Phone: 650-852-3287
• EMail: Jerome.Yesavage@va.gov

Publications:

Mi Z, Biswas K, Fairchild JK, Davis-Karim A, Phibbs CS, Forman SD, Thase M, Georgette G, Beale T, Pittman D, McNerney MW, Rosen A, Huang GD, George M, Noda A, Yesavage JA. Repetitive transcranial magnetic stimulation (rTMS) for treatment-resistant major depression (TRMD) Veteran patients: study protocol for a randomized controlled trial. Trials. 2017 Sep 2;18(1):409. doi: 10.1186/s13063-017-2125-y.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Yesavage JA, Fairchild JK, Mi Z, Biswas K, Davis-Karim A, Phibbs CS, Forman SD, Thase M, Williams LM, Etkin A, O'Hara R, Georgette G, Beale T, Huang GD, Noda A, George MS; VA Cooperative Studies Program Study Team. Effect of Repetitive Transcranial Magnetic Stimulation on Treatment-Resistant Major Depression in US Veterans: A Randomized Clinical Trial. JAMA Psychiatry. 2018 Sep 1;75(9):884-893. doi: 10.1001/jamapsychiatry.2018.1483.

• Responsible Party: VA Office of Research and Development
• ClinicalTrials.gov Identifier: NCT01191333
• Other Study ID Numbers: 556
• First Submitted: August 26, 2010
• First Posted: August 30, 2010
• Results First Submitted: January 10, 2018
• Results First Posted: February 7, 2018
• Last Update Posted: March 9, 2018