Interventional procedure overview of transcutaneous electrical stimulation of the trigeminal nerve for ADHD
Closed for comments This consultation ended on at Request commenting lead permission
Safety summary
Cognitive functioning
Speech
In the open-label trial of 24 children, there were 2 (8%) cases of difficulty finding words and 2 (8%) cases of slurred speech (McGough, 2015).
Diminished mental acuity/sharpness
In the open-label trial of 24 children, there were 3 (13%) cases of diminished mental acuity/sharpness (McGough, 2015).
Poor memory
In the open-label trial of 24 children, there were 11 (46%) cases of poor memory. The authors note that this is a symptom of ADHD (McGough, 2015).
Trouble concentrating
In the open-label trial of 24 children, there were 22 (92%) cases of trouble concentrating and 17 (71%) cases of poor concentration. The authors note that these are symptoms of ADHD (McGough, 2015).
Slurred speech
In the open-label trial of 24 children, there were 2 (8%) cases of slurred speech (McGough, 2015).
Sleep
Trouble sleeping
In the RCT of 62 children, there were 6 (19%) cases of trouble sleeping in the active arm and 5 (17%) cases in the sham arm (McGough, 2019).
In the open-label trial of 24 children, there were 7 (29%) cases of trouble sleeping (McGough, 2015).
Nightmares
In the RCT of 62 children, there were 2 (6%) cases of nightmares in the active arm and 1 (3%) case in the sham arm (McGough, 2019).
In the open-label trial of 24 children, there were 5 (21%) cases of nightmares (McGough, 2015).
Emotional
Apathy
In the RCT of 62 children, there were 2 (6%) cases of apathy in the active arm and 2 (7%) cases in the sham arm (McGough, 2019).
In the open-label trial of 24 children, there were 3 (13%) cases of apathy (McGough, 2015).
Feeling drowsy
In the RCT of 62 children, there were 7 (22%) cases of drowsiness in the active arm and 4 (13%) cases in the sham arm (McGough, 2019).
In the open-label trial of 24 children, there were 5 (21%) cases of drowsiness (McGough, 2015).
Feeling nervous
In the open-label trial of 24 children, there were 14 (58%) cases of feeling nervous (McGough, 2015).
Feeling strange or unreal
In the open-label trial of 24 children, there were 2 (8%) cases of feeling strange or unreal (McGough, 2015).
Other symptoms
Lightheaded
In the RCT of 62 children, there was 1 (3%) case of lightheadedness in the active arm and 0 cases in the sham arm (McGough, 2019).
Fatigue
In the RCT of 62 children, there were 4 (13%) cases of fatigue in the active arm and 1 (3%) case in the sham arm (McGough, 2019).
In the open-label trial of 24 children, there were 5 (21%) cases of weakness or fatigue (McGough, 2015).
Tingling
In the RCT of 62 children, there was 1 (3%) case of tingling in the active arm and 0 cases in the sham arm (McGough, 2019).
Headache
In the RCT of 62 children, there were 4 (13%) cases of headache in the active arm and 0 cases in the sham arm (McGough, 2019).
In the open-label trial of 24 children, there were 3 (13%) cases of headache (McGough, 2015).
Hyperactive
In the RCT of 62 children, there were 13 (41%) cases of hyperactivity in the active arm and 19 (63%) cases in the sham arm (McGough, 2019).
In the open-label trial of 24 children, there were 17 (71%) cases of trouble sitting still. The authors note that this is a symptom of ADHD (McGough, 2015).
Irritability
In the open-label trial of 24 children, there were 10 (42%) cases of irritability (McGough, 2015).
Stuffy nose
In the RCT of 62 children, there were 5 (16%) cases of stuffy nose in the active arm and 6 (20%) cases in the sham arm (McGough, 2019).
In the open-label trial of 24 children, there were 6 (24%) cases of stuffy nose (McGough, 2015).
Drooling
In the open-label trial of 24 children, there were 2 (8%) cases of drooling (McGough, 2015).
Muscle cramps
In the RCT of 62 children, there was 1 (3%) case of muscle cramps in the active arm and 1 (3%) case in the sham arm (McGough, 2019).
Muscle twitch
In the open-label trial of 24 children, there were 2 (8%) cases of muscle twitch (McGough, 2015).
Rapid heartbeat
In the RCT of 62 children, there was 1 (3%) case of rapid heartbeat in the active arm and 0 cases in the sham arm (McGough, 2019).
Out of breath
In the RCT of 62 children, there was 1 (3%) case of breathlessness in the active arm and 1 (3%) case in the sham arm (McGough, 2019).
Excess sweating
In the RCT of 62 children, there was 1 (3%) case of frequent sweating in the active arm and 1 (3%) case in the sham arm (McGough, 2019).
In the open-label trial of 24 children, there were 2 (8%) cases of excess sweating (McGough, 2015).
Itching
In the RCT of 62 children, there was 1 (3%) case of itching in the active arm and 0 cases in the sham arm (McGough, 2019).
Tooth pain
In the RCT of 62 children, there was 1 (3%) case of tooth pain in the active arm and 0 cases in the sham arm (McGough, 2019).
Clenching teeth
In the RCT of 62 children, there were 4 (13%) cases of clenching teeth in the active arm and 2 (7%) cases in the sham arm (McGough, 2019).
Skin whitening/discolouration
In the RCT of 62 children, there was 1 (3%) case of skin whitening/discolouration in the active arm and 1 (3%) case in the sham arm. This was attributed to removal of the electrodes (McGough, 2019).
Skin rash
In the RCT of 62 children, there were 3 (9%) cases of skin rash in the active arm and 0 cases in the sham arm (McGough, 2019).
Frequent urination
In the RCT of 62 children, there were 2 (6%) cases of frequent urination in the active arm and 0 cases in the sham arm (McGough, 2019).
Bronchitis
In the RCT of 62 children, there was 1 (3%) case of bronchitis in the active arm and 0 cases in the sham arm (McGough, 2019).
Upper respiratory infection
In the RCT of 62 children, there were 3 (9%) cases of upper respiratory infections in the active arm and 3 (10%) cases in the sham arm (McGough, 2019).
Rhinitis
In the RCT of 62 children, there were 2 (6%) cases of rhinitis in the active arm and 2 (6%) cases in the sham arm (McGough, 2019).
Vomiting
In the RCT of 62 children, there was 1 (3%) case of vomiting in the active arm and 0 cases in the sham arm (McGough, 2019).
Gastrointestinal
Nausea
In the RCT of 62 children, there were 2 (6%) cases of nausea in the active arm and 0 cases in the sham arm (McGough, 2019).
Stomach ache
In the RCT of 62 children, there were 4 (12%) cases of stomach ache in the active arm and 2 (6%) cases in the sham arm (McGough, 2019).
In the open-label trial of 24 children, there were 2 (8%) cases of stomach discomfort (McGough, 2015).
Weight gain
In the open-label trial of 24 children, there were 2 (8%) cases of weight gain (McGough, 2015).
Constipation
In the RCT of 62 children, there were 3 (9%) cases of constipation in the active arm and 2 (7%) cases in the sham arm (McGough, 2019).
Decreased appetite
In the RCT of 62 children, there was 1 (3%) case of decreased appetite in the active arm and 1 (3%) case in the sham arm (McGough, 2019).
Poor appetite
In the RCT of 62 children, there was 1 (3%) case of poor appetite in the active arm and 0 cases in the sham arm (McGough, 2019).
Increased appetite
In the RCT of 62 children, there were 6 (19%) cases of increased appetite in the active arm and 2 (7%) cases in the sham arm (McGough, 2019).
Anecdotal and theoretical adverse events
In addition to safety outcomes reported in the literature, professional experts are asked about anecdotal adverse events (events that they have heard about) and about theoretical adverse events (events that they think might possibly occur, even if they have never happened).
For this procedure, the professional experts did not list any anecdotal or theoretical adverse events.
How are you taking part in this consultation?
You will not be able to change how you comment later.
You must be signed in to answer questions