Study: NCT01504958

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Reported headaches ranged from mild to moderate post-intervention as compared to pre-intervention. Most were assessed as possibly/probably related to the study.
Frequency: 5 affected / 10 at risk

Adverse event: Neck pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Reported mild neck pain/stiffness post-intervention.
Frequency: 3 affected / 10 at risk

Adverse event: Pain of skin
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Reported mild scalp pain post-intervention
Frequency: 3 affected / 10 at risk

Adverse event: Hearing Impairment
Serious: no
Organ System: Ear and labyrinth disorders
Notes: Reported mild hearing impairment post-intervention as compared to pre-intervention. Earplugs were worn throughout every session. No long term hearing impairment reported.
Frequency: 1 affected / 10 at risk

Adverse event: Fatigue
Serious: no
Organ System: Nervous system disorders
Notes: Reported mild tiredness post-intervention as compared to pre-intervention.
Frequency: 3 affected / 10 at risk

Adverse event: Soreness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Participant reported mild soreness at the inferior frontal gyrus (stimulation site) post-stimulation.
Frequency: 1 affected / 10 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Notes: Blurry vision reported after looking at computer screen for extended period of time
Frequency: 1 affected / 10 at risk

Adverse event: Anxiousness
Serious: no
Organ System: Psychiatric disorders
Notes: Reported increase in anxiety post-intervention
Frequency: 1 affected / 10 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Notes: Reported mild dizziness post-intervention as compared to pre-intervention.
Frequency: 1 affected / 10 at risk

Adverse event: Achiness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Reported mild achiness post-intervention.
Frequency: 1 affected / 10 at risk

Adverse event: Muscle Heaviness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Reported mild eye heaviness post-intervention. No long term effects.
Frequency: 1 affected / 10 at risk

Adverse event: Muscle twitching
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Subject experienced twitching in bicep and wrist flexor of the right arm at the beginning of a TMS session that lasted for 5 seconds and resolved. Subject also reported nausea and session was discontinued.
Frequency: 1 affected / 6 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Reported headaches ranged from mild to moderate post-intervention as compared to pre-intervention. Most were assessed as possibly/probably related to the study.
Frequency: 5 affected / 6 at risk

Adverse event: Neck pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Reported mild neck pain/stiffness post-intervention.
Frequency: 2 affected / 6 at risk

Adverse event: Hearing Impairment
Serious: no
Organ System: Ear and labyrinth disorders
Notes: Reported mild hearing impairment post-intervention as compared to pre-intervention. Earplugs were worn throughout every session. No long term hearing impairment reported.
Frequency: 1 affected / 6 at risk

Adverse event: Impaired Cognition
Serious: no
Organ System: Nervous system disorders
Notes: Reported mild impaired cognition post-intervention compared to pre-intervention. Most reported as tiredness. No long term impairment reported.
Frequency: 1 affected / 6 at risk

Adverse event: Trouble Concentrating
Serious: no
Organ System: Nervous system disorders
Notes: Reported mild trouble concentrating post-intervention as compared to pre-intervention. Most reported as tiredness. No long term trouble reported.
Frequency: 4 affected / 6 at risk

Adverse event: Fatigue
Serious: no
Organ System: Nervous system disorders
Notes: Reported mild tiredness post-intervention as compared to pre-intervention.
Frequency: 1 affected / 6 at risk

Adverse event: Anxiousness
Serious: no
Organ System: Psychiatric disorders
Notes: Reported increase in anxiety post-intervention
Frequency: 1 affected / 6 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Notes: Reported mild dizziness post-intervention as compared to pre-intervention.
Frequency: 1 affected / 6 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Notes: Participant reported feeling mildly subdued/dazed/depressed following intervention. No long term effects.
Frequency: 1 affected / 6 at risk

Adverse event: Rib fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: A subject sustained a 5cm contusion and subtle rib fracture resulting from a fall at home. Subject was brought to the hospital for evaluation. Subject was in the follow up phase. This was assessed as unlikely related to to the study.
Frequency: 1 affected / 6 at risk