Trial Outcomes & Findings for Double-Blind 2-Site Randomized Clinical Trial of Neurofeedback for ADHD (NCT NCT02251743)

Last Updated: 2020-09-29

Results Overview

The primary outcome measure is the composite scores of teacher and parent-rated inattentive symptoms on the Conners-3, rated on a scale of 0-3. Lower scores represent a better outcome, with a maximum score of 3 and a minimum score of 0.

Recruitment status

COMPLETED

Study phase

Target enrollment

144 participants

Primary outcome timeframe

Assessed at Baseline, Mid-treatment (2 months), End-treatment (4 months), at 6 month follow up, at 13 month follow up

Results posted on

2020-09-29

Participant Flow

Of 329 children screened, 305 passed categorical and parent-rated dimensional criteria for ADHD. Of these, 235 passed the TBR screen. Of the149 completely eligible,144 were randomized, and of the 144, 2 withdrew consent for logistical reasons before any post-treatment assessment. Thus,142 subjects comprised the population for the primary analysis.

Participant milestones

Participant milestones
Measure	Neurofeedback Treatment The intended treatment is downtraining of theta power and uptraining of beta power for 38 treatments of active NF. Neurofeedback treatment: Each session, the child participates in 5 training tasks. Each task lasts 5 minutes at the beginning and gradually increases to 9 minutes per task over the course of the neurofeedback as the child's attention span improves. We record four results for each of the 5 tasks: 1. The number of half-second periods that they met the reward parameters (i.e. theta mV below threshold; beta mV above threshold) 2. Average voltage of theta waves 3. Average voltage of beta 4. Average ratio of theta to beta power (TBR)	Sham Neurofeedback Treatment Participants assigned to sham and their trainers will be fed EEG data from pre-recorded files (recorded during live clinical NF) rather than from the participant's live signal. In order to prevent unblinding of experienced NF trainers/technicians, artifacts from the participant's EMG and EOG are blended into the pre-recorded EEG so that the trainer controlling the feedback cannot differentiate between live and simulated data. To insure trainer/technician blindness, the pre-recorded EEG will be 38 consecutive EEGs from the same age-matched clinical case so that EEGs of the sham group will also show "training progress" over successive sessions, like real NF. Neurofeedback treatment: Each session, the child participates in 5 training tasks. Each task lasts 5 minutes at the beginning and gradually increases to 9 minutes per task over the course of the neurofeedback as the child's attention span improves. We record four results for each of the 5 tasks.
Overall Study STARTED	85	59
Overall Study COMPLETED	84	58
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Neurofeedback Treatment The intended treatment is downtraining of theta power and uptraining of beta power for 38 treatments of active NF. Neurofeedback treatment: Each session, the child participates in 5 training tasks. Each task lasts 5 minutes at the beginning and gradually increases to 9 minutes per task over the course of the neurofeedback as the child's attention span improves. We record four results for each of the 5 tasks: 1. The number of half-second periods that they met the reward parameters (i.e. theta mV below threshold; beta mV above threshold) 2. Average voltage of theta waves 3. Average voltage of beta 4. Average ratio of theta to beta power (TBR)	Sham Neurofeedback Treatment Participants assigned to sham and their trainers will be fed EEG data from pre-recorded files (recorded during live clinical NF) rather than from the participant's live signal. In order to prevent unblinding of experienced NF trainers/technicians, artifacts from the participant's EMG and EOG are blended into the pre-recorded EEG so that the trainer controlling the feedback cannot differentiate between live and simulated data. To insure trainer/technician blindness, the pre-recorded EEG will be 38 consecutive EEGs from the same age-matched clinical case so that EEGs of the sham group will also show "training progress" over successive sessions, like real NF. Neurofeedback treatment: Each session, the child participates in 5 training tasks. Each task lasts 5 minutes at the beginning and gradually increases to 9 minutes per task over the course of the neurofeedback as the child's attention span improves. We record four results for each of the 5 tasks.
Overall Study Withdrawal by Subject	1	1

Baseline Characteristics

Double-Blind 2-Site Randomized Clinical Trial of Neurofeedback for ADHD

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Neurofeedback Treatment n=84 Participants The intended treatment is downtraining of theta power and uptraining of beta power for 38 treatments of active NF. Neurofeedback treatment: Each session, the child participates in 5 training tasks. Each task lasts 5 minutes at the beginning and gradually increases to 9 minutes per task over the course of the neurofeedback as the child's attention span improves. We record four results for each of the 5 tasks: 1. The number of half-second periods that they met the reward parameters (i.e. theta mV below threshold; beta mV above threshold) 2. Average voltage of theta waves 3. Average voltage of beta 4. Average ratio of theta to beta power (TBR)	Sham Neurofeedback Treatment n=58 Participants Participants assigned to sham and their trainers will be fed EEG data from pre-recorded files (recorded during live clinical NF) rather than from the participant's live signal. In order to prevent unblinding of experienced NF trainers/technicians, artifacts from the participant's EMG and EOG are blended into the pre-recorded EEG so that the trainer controlling the feedback cannot differentiate between live and simulated data. To insure trainer/technician blindness, the pre-recorded EEG will be 38 consecutive EEGs from the same age-matched clinical case so that EEGs of the sham group will also show "training progress" over successive sessions, like real NF. Neurofeedback treatment: Each session, the child participates in 5 training tasks. Each task lasts 5 minutes at the beginning and gradually increases to 9 minutes per task over the course of the neurofeedback as the child's attention span improves. We record four results for each of the 5 tasks.	Total n=142 Participants Total of all reporting groups
Number of school changes 2 or more	11 Participants n=93 Participants	9 Participants n=4 Participants	20 Participants n=27 Participants
Special Education Services Individual Educational Plan	23 participants n=93 Participants	20 participants n=4 Participants	43 participants n=27 Participants
Special Education Services 504 Plan	10 participants n=93 Participants	12 participants n=4 Participants	22 participants n=27 Participants
Special Education Services Special accommodations	15 participants n=93 Participants	11 participants n=4 Participants	26 participants n=27 Participants
ADHD Subtype Inattentive	31 Participants n=93 Participants	20 Participants n=4 Participants	51 Participants n=27 Participants
Age, Continuous	8.67 years STANDARD_DEVIATION 1.1 • n=93 Participants	8.51 years STANDARD_DEVIATION 1.17 • n=4 Participants	8.58 years STANDARD_DEVIATION 1.14 • n=27 Participants
Sex: Female, Male Female	19 Participants n=93 Participants	12 Participants n=4 Participants	31 Participants n=27 Participants
Sex: Female, Male Male	65 Participants n=93 Participants	46 Participants n=4 Participants	111 Participants n=27 Participants
Race/Ethnicity, Customized Hispanic/Latino	13 Participants n=93 Participants	6 Participants n=4 Participants	19 Participants n=27 Participants
Race/Ethnicity, Customized White	64 Participants n=93 Participants	42 Participants n=4 Participants	106 Participants n=27 Participants
Race/Ethnicity, Customized Black/African American	7 Participants n=93 Participants	4 Participants n=4 Participants	11 Participants n=27 Participants
Race/Ethnicity, Customized Asian	0 Participants n=93 Participants	5 Participants n=4 Participants	5 Participants n=27 Participants
Race/Ethnicity, Customized Other	4 Participants n=93 Participants	0 Participants n=4 Participants	4 Participants n=27 Participants
Race/Ethnicity, Customized Multi-Race	7 Participants n=93 Participants	6 Participants n=4 Participants	13 Participants n=27 Participants
Race/Ethnicity, Customized Unknown	2 Participants n=93 Participants	1 Participants n=4 Participants	3 Participants n=27 Participants
Primary Living Arrangement Parental (at least one parent)	80 Participants n=93 Participants	52 Participants n=4 Participants	132 Participants n=27 Participants
Primary Living Arrangement Parental (shared custody)	3 Participants n=93 Participants	5 Participants n=4 Participants	8 Participants n=27 Participants
Primary Living Arrangement Relative other than parents	1 Participants n=93 Participants	1 Participants n=4 Participants	2 Participants n=27 Participants
Number of Adults in Home	1.94 average number of adults in home STANDARD_DEVIATION 0.61 • n=93 Participants	2.14 average number of adults in home STANDARD_DEVIATION 0.78 • n=4 Participants	2.02 average number of adults in home STANDARD_DEVIATION 0.69 • n=27 Participants
Number of Children in Home	2.12 average number of children in home STANDARD_DEVIATION 1.03 • n=93 Participants	2.12 average number of children in home STANDARD_DEVIATION 0.88 • n=4 Participants	2.12 average number of children in home STANDARD_DEVIATION 0.97 • n=27 Participants
Primary Caregiver Biological Mother	67 Participants n=93 Participants	49 Participants n=4 Participants	116 Participants n=27 Participants
Primary Caregiver Biological Father	7 Participants n=93 Participants	2 Participants n=4 Participants	9 Participants n=27 Participants
Primary Caregiver Adoptive Mother	8 Participants n=93 Participants	6 Participants n=4 Participants	14 Participants n=27 Participants
Primary Caregiver Grandmother	2 Participants n=93 Participants	1 Participants n=4 Participants	3 Participants n=27 Participants
Child's Educational setting Regular public school	32 Participants n=93 Participants	25 Participants n=4 Participants	57 Participants n=27 Participants
Child's Educational setting Regular private/parochial school	30 Participants n=93 Participants	27 Participants n=4 Participants	57 Participants n=27 Participants
Child's Educational setting Regular school + special classes	6 Participants n=93 Participants	3 Participants n=4 Participants	9 Participants n=27 Participants
Child's Educational setting Home schooled	3 Participants n=93 Participants	0 Participants n=4 Participants	3 Participants n=27 Participants
Child's Educational setting Charter School	13 Participants n=93 Participants	3 Participants n=4 Participants	16 Participants n=27 Participants
Child's Current grade 1	15 Participants n=93 Participants	7 Participants n=4 Participants	22 Participants n=27 Participants
Child's Current grade 2	23 Participants n=93 Participants	15 Participants n=4 Participants	38 Participants n=27 Participants
Child's Current grade 3	25 Participants n=93 Participants	18 Participants n=4 Participants	43 Participants n=27 Participants
Child's Current grade 4	12 Participants n=93 Participants	13 Participants n=4 Participants	25 Participants n=27 Participants
Child's Current grade 5	9 Participants n=93 Participants	5 Participants n=4 Participants	14 Participants n=27 Participants
Repeated Grade	6 Participants n=93 Participants	1 Participants n=4 Participants	7 Participants n=27 Participants
Number of school changes 0	48 Participants n=93 Participants	32 Participants n=4 Participants	80 Participants n=27 Participants
Number of school changes 1	25 Participants n=93 Participants	17 Participants n=4 Participants	42 Participants n=27 Participants
ADHD Subtype Combined	53 Participants n=93 Participants	38 Participants n=4 Participants	91 Participants n=27 Participants
ADHD Medication	23 Participants n=93 Participants	18 Participants n=4 Participants	41 Participants n=27 Participants
Composite Conner's Subscale (Parent and Teacher) ADHD Inattentiveness	2 units on a scale STANDARD_DEVIATION 0.51 • n=93 Participants	2.08 units on a scale STANDARD_DEVIATION 0.51 • n=4 Participants	2.03 units on a scale STANDARD_DEVIATION 0.51 • n=27 Participants
Composite Conner's Subscale (Parent and Teacher) ADHD Hyperactivity-Impulsivity	1.68 units on a scale STANDARD_DEVIATION 0.77 • n=93 Participants	1.88 units on a scale STANDARD_DEVIATION 0.66 • n=4 Participants	1.77 units on a scale STANDARD_DEVIATION 0.73 • n=27 Participants
Composite Conner's Subscale (Parent and Teacher) Inattentive	2.04 units on a scale STANDARD_DEVIATION 0.52 • n=93 Participants	2.13 units on a scale STANDARD_DEVIATION 0.49 • n=4 Participants	2.08 units on a scale STANDARD_DEVIATION 0.51 • n=27 Participants
Composite Conner's Subscale (Parent and Teacher) Hyperactivity-Impulsivity	1.71 units on a scale STANDARD_DEVIATION 0.78 • n=93 Participants	1.92 units on a scale STANDARD_DEVIATION 0.64 • n=4 Participants	1.79 units on a scale STANDARD_DEVIATION 0.73 • n=27 Participants
Composite Conner's Subscale (Parent and Teacher) Learning Problems	1.31 units on a scale STANDARD_DEVIATION 0.71 • n=93 Participants	1.18 units on a scale STANDARD_DEVIATION 0.75 • n=4 Participants	1.25 units on a scale STANDARD_DEVIATION 0.73 • n=27 Participants
Composite Conner's Subscale (Parent and Teacher) Executive Functioning	1.9 units on a scale STANDARD_DEVIATION 0.62 • n=93 Participants	1.96 units on a scale STANDARD_DEVIATION 0.58 • n=4 Participants	1.92 units on a scale STANDARD_DEVIATION 0.6 • n=27 Participants
Composite Conner's Subscale (Parent and Teacher) Aggression	0.46 units on a scale STANDARD_DEVIATION 0.44 • n=93 Participants	0.46 units on a scale STANDARD_DEVIATION 0.42 • n=4 Participants	0.46 units on a scale STANDARD_DEVIATION 0.43 • n=27 Participants
Composite Conner's Subscale (Parent and Teacher) Peer Relations	0.73 units on a scale STANDARD_DEVIATION 0.67 • n=93 Participants	0.66 units on a scale STANDARD_DEVIATION 0.68 • n=4 Participants	0.7 units on a scale STANDARD_DEVIATION 0.67 • n=27 Participants
Composite Conner's Subscale (Parent and Teacher) Global Index	1.49 units on a scale STANDARD_DEVIATION 0.59 • n=93 Participants	1.61 units on a scale STANDARD_DEVIATION 0.5 • n=4 Participants	1.54 units on a scale STANDARD_DEVIATION 0.56 • n=27 Participants
Composite Conner's Subscale (Parent and Teacher) Conduct Disorder	0.17 units on a scale STANDARD_DEVIATION 0.21 • n=93 Participants	0.15 units on a scale STANDARD_DEVIATION 0.22 • n=4 Participants	0.16 units on a scale STANDARD_DEVIATION 0.22 • n=27 Participants
Composite Conner's Subscale (Parent and Teacher) Oppositional Defiant	0.87 units on a scale STANDARD_DEVIATION 0.67 • n=93 Participants	0.92 units on a scale STANDARD_DEVIATION 0.6 • n=4 Participants	0.89 units on a scale STANDARD_DEVIATION 0.64 • n=27 Participants
Composite Conner's Subscale (Parent and Teacher) Positive Impression Index	0.32 units on a scale STANDARD_DEVIATION 0.31 • n=93 Participants	0.33 units on a scale STANDARD_DEVIATION 0.32 • n=4 Participants	0.33 units on a scale STANDARD_DEVIATION 0.31 • n=27 Participants
Composite Conner's Subscale (Parent and Teacher) Negative Impression Index	0.18 units on a scale STANDARD_DEVIATION 0.23 • n=93 Participants	0.19 units on a scale STANDARD_DEVIATION 0.24 • n=4 Participants	0.18 units on a scale STANDARD_DEVIATION 0.23 • n=27 Participants
CHIPS Oppositional-Defiant Disorder	41 number of participants n=93 Participants	30 number of participants n=4 Participants	71 number of participants n=27 Participants
CHIPS Specific Phobias	15 number of participants n=93 Participants	9 number of participants n=4 Participants	24 number of participants n=27 Participants
CHIPS Generalized Anxiety Disorder	16 number of participants n=93 Participants	8 number of participants n=4 Participants	24 number of participants n=27 Participants
CHIPS Separation Anxiety	9 number of participants n=93 Participants	2 number of participants n=4 Participants	11 number of participants n=27 Participants
CHIPS Social Phobia	3 number of participants n=93 Participants	0 number of participants n=4 Participants	3 number of participants n=27 Participants

PRIMARY outcome

Timeframe: Assessed at Baseline, Mid-treatment (2 months), End-treatment (4 months), at 6 month follow up, at 13 month follow up

Outcome measures

Outcome measures
Measure	Neurofeedback Treatment n=84 Participants The intended treatment is downtraining of theta power and uptraining of beta power for 38 treatments of active NF. Neurofeedback treatment: Each session, the child participates in 5 training tasks. Each task lasts 5 minutes at the beginning and gradually increases to 9 minutes per task over the course of the neurofeedback as the child's attention span improves. We record four results for each of the 5 tasks: 1. The number of half-second periods that they met the reward parameters (i.e. theta mV below threshold; beta mV above threshold) 2. Average voltage of theta waves 3. Average voltage of beta 4. Average ratio of theta to beta power (TBR)	Sham Neurofeedback Treatment n=58 Participants Participants assigned to sham and their trainers will be fed EEG data from pre-recorded files (recorded during live clinical NF) rather than from the participant's live signal. In order to prevent unblinding of experienced NF trainers/technicians, artifacts from the participant's EMG and EOG are blended into the pre-recorded EEG so that the trainer controlling the feedback cannot differentiate between live and simulated data. To insure trainer/technician blindness, the pre-recorded EEG will be 38 consecutive EEGs from the same age-matched clinical case so that EEGs of the sham group will also show "training progress" over successive sessions, like real NF. Neurofeedback treatment: Each session, the child participates in 5 training tasks. Each task lasts 5 minutes at the beginning and gradually increases to 9 minutes per task over the course of the neurofeedback as the child's attention span improves. We record four results for each of the 5 tasks.
Scores of Teacher and Parent Rated Inattentive Symptoms End-Treatment	1.43 units on a scale Standard Deviation 0.51	1.54 units on a scale Standard Deviation 0.44
Scores of Teacher and Parent Rated Inattentive Symptoms 6 month follow up	1.50 units on a scale Standard Deviation 0.52	1.52 units on a scale Standard Deviation 0.50
Scores of Teacher and Parent Rated Inattentive Symptoms Baseline	2.00 units on a scale Standard Deviation 0.37	2.08 units on a scale Standard Deviation 0.38
Scores of Teacher and Parent Rated Inattentive Symptoms Mid-Treatment	1.51 units on a scale Standard Deviation 0.49	1.60 units on a scale Standard Deviation 0.46
Scores of Teacher and Parent Rated Inattentive Symptoms 13 month follow up	1.37 units on a scale Standard Deviation 0.56	1.58 units on a scale Standard Deviation 0.52

Adverse Events

Neurofeedback Treatment

Serious events: 0 serious events

Other events: 75 other events

Deaths: 0 deaths

Sham Neurofeedback Treatment

Serious events: 0 serious events

Other events: 50 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Dr. L Eugene Arnold

Ohio State University

Phone: 614-685-6701

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Neurofeedback Treatment n=84 participants at risk The intended treatment is downtraining of theta power and uptraining of beta power for 38 treatments of active NF. Neurofeedback treatment: Each session, the child participates in 5 training tasks. Each task lasts 5 minutes at the beginning and gradually increases to 9 minutes per task over the course of the neurofeedback as the child's attention span improves. We record four results for each of the 5 tasks: 1. The number of half-second periods that they met the reward parameters (i.e. theta mV below threshold; beta mV above threshold) 2. Average voltage of theta waves 3. Average voltage of beta 4. Average ratio of theta to beta power (TBR)	Sham Neurofeedback Treatment n=58 participants at risk Participants assigned to sham and their trainers will be fed EEG data from pre-recorded files (recorded during live clinical NF) rather than from the participant's live signal. In order to prevent unblinding of experienced NF trainers/technicians, artifacts from the participant's EMG and EOG are blended into the pre-recorded EEG so that the trainer controlling the feedback cannot differentiate between live and simulated data. To insure trainer/technician blindness, the pre-recorded EEG will be 38 consecutive EEGs from the same age-matched clinical case so that EEGs of the sham group will also show "training progress" over successive sessions, like real NF. Neurofeedback treatment: Each session, the child participates in 5 training tasks. Each task lasts 5 minutes at the beginning and gradually increases to 9 minutes per task over the course of the neurofeedback as the child's attention span improves. We record four results for each of the 5 tasks.
Nervous system disorders Headache	10.7% 9/84 • Adverse event data were collected at every visit- from baseline, at the first session of each week, and at 13-month follow up (~1.5 years).	8.6% 5/58 • Adverse event data were collected at every visit- from baseline, at the first session of each week, and at 13-month follow up (~1.5 years).
Social circumstances Irritability	8.3% 7/84 • Adverse event data were collected at every visit- from baseline, at the first session of each week, and at 13-month follow up (~1.5 years).	12.1% 7/58 • Adverse event data were collected at every visit- from baseline, at the first session of each week, and at 13-month follow up (~1.5 years).
Social circumstances Oppositionality	8.3% 7/84 • Adverse event data were collected at every visit- from baseline, at the first session of each week, and at 13-month follow up (~1.5 years).	12.1% 7/58 • Adverse event data were collected at every visit- from baseline, at the first session of each week, and at 13-month follow up (~1.5 years).
Psychiatric disorders Depressed mood	4.8% 4/84 • Adverse event data were collected at every visit- from baseline, at the first session of each week, and at 13-month follow up (~1.5 years).	6.9% 4/58 • Adverse event data were collected at every visit- from baseline, at the first session of each week, and at 13-month follow up (~1.5 years).
General disorders Difficulty initiating sleep	7.1% 6/84 • Adverse event data were collected at every visit- from baseline, at the first session of each week, and at 13-month follow up (~1.5 years).	3.4% 2/58 • Adverse event data were collected at every visit- from baseline, at the first session of each week, and at 13-month follow up (~1.5 years).
General disorders Fatigue	6.0% 5/84 • Adverse event data were collected at every visit- from baseline, at the first session of each week, and at 13-month follow up (~1.5 years).	5.2% 3/58 • Adverse event data were collected at every visit- from baseline, at the first session of each week, and at 13-month follow up (~1.5 years).
General disorders Sleep Symptoms, NOS	4.8% 4/84 • Adverse event data were collected at every visit- from baseline, at the first session of each week, and at 13-month follow up (~1.5 years).	5.2% 3/58 • Adverse event data were collected at every visit- from baseline, at the first session of each week, and at 13-month follow up (~1.5 years).
Psychiatric disorders Anxiety	3.6% 3/84 • Adverse event data were collected at every visit- from baseline, at the first session of each week, and at 13-month follow up (~1.5 years).	5.2% 3/58 • Adverse event data were collected at every visit- from baseline, at the first session of each week, and at 13-month follow up (~1.5 years).
Social circumstances Hyperactivity	6.0% 5/84 • Adverse event data were collected at every visit- from baseline, at the first session of each week, and at 13-month follow up (~1.5 years).	1.7% 1/58 • Adverse event data were collected at every visit- from baseline, at the first session of each week, and at 13-month follow up (~1.5 years).
Social circumstances Aggression	2.4% 2/84 • Adverse event data were collected at every visit- from baseline, at the first session of each week, and at 13-month follow up (~1.5 years).	5.2% 3/58 • Adverse event data were collected at every visit- from baseline, at the first session of each week, and at 13-month follow up (~1.5 years).
General disorders Agitation	3.6% 3/84 • Adverse event data were collected at every visit- from baseline, at the first session of each week, and at 13-month follow up (~1.5 years).	3.4% 2/58 • Adverse event data were collected at every visit- from baseline, at the first session of each week, and at 13-month follow up (~1.5 years).
Social circumstances Impulsivity	2.4% 2/84 • Adverse event data were collected at every visit- from baseline, at the first session of each week, and at 13-month follow up (~1.5 years).	3.4% 2/58 • Adverse event data were collected at every visit- from baseline, at the first session of each week, and at 13-month follow up (~1.5 years).
General disorders Crying	3.6% 3/84 • Adverse event data were collected at every visit- from baseline, at the first session of each week, and at 13-month follow up (~1.5 years).	0.00% 0/58 • Adverse event data were collected at every visit- from baseline, at the first session of each week, and at 13-month follow up (~1.5 years).
General disorders Labile mood	2.4% 2/84 • Adverse event data were collected at every visit- from baseline, at the first session of each week, and at 13-month follow up (~1.5 years).	1.7% 1/58 • Adverse event data were collected at every visit- from baseline, at the first session of each week, and at 13-month follow up (~1.5 years).
Nervous system disorders Sedation	3.6% 3/84 • Adverse event data were collected at every visit- from baseline, at the first session of each week, and at 13-month follow up (~1.5 years).	0.00% 0/58 • Adverse event data were collected at every visit- from baseline, at the first session of each week, and at 13-month follow up (~1.5 years).
Nervous system disorders Tic disorders	1.2% 1/84 • Adverse event data were collected at every visit- from baseline, at the first session of each week, and at 13-month follow up (~1.5 years).	3.4% 2/58 • Adverse event data were collected at every visit- from baseline, at the first session of each week, and at 13-month follow up (~1.5 years).
General disorders Back pain	2.4% 2/84 • Adverse event data were collected at every visit- from baseline, at the first session of each week, and at 13-month follow up (~1.5 years).	0.00% 0/58 • Adverse event data were collected at every visit- from baseline, at the first session of each week, and at 13-month follow up (~1.5 years).
Social circumstances Behavioral, NOS	1.2% 1/84 • Adverse event data were collected at every visit- from baseline, at the first session of each week, and at 13-month follow up (~1.5 years).	1.7% 1/58 • Adverse event data were collected at every visit- from baseline, at the first session of each week, and at 13-month follow up (~1.5 years).
General disorders Difficulty maintaining sleep	1.2% 1/84 • Adverse event data were collected at every visit- from baseline, at the first session of each week, and at 13-month follow up (~1.5 years).	1.7% 1/58 • Adverse event data were collected at every visit- from baseline, at the first session of each week, and at 13-month follow up (~1.5 years).
General disorders Dizziness	2.4% 2/84 • Adverse event data were collected at every visit- from baseline, at the first session of each week, and at 13-month follow up (~1.5 years).	0.00% 0/58 • Adverse event data were collected at every visit- from baseline, at the first session of each week, and at 13-month follow up (~1.5 years).
Eye disorders Eye pain	2.4% 2/84 • Adverse event data were collected at every visit- from baseline, at the first session of each week, and at 13-month follow up (~1.5 years).	0.00% 0/58 • Adverse event data were collected at every visit- from baseline, at the first session of each week, and at 13-month follow up (~1.5 years).
General disorders Self-injurious behavior	1.2% 1/84 • Adverse event data were collected at every visit- from baseline, at the first session of each week, and at 13-month follow up (~1.5 years).	1.7% 1/58 • Adverse event data were collected at every visit- from baseline, at the first session of each week, and at 13-month follow up (~1.5 years).
Psychiatric disorders Suicidal ideation	0.00% 0/84 • Adverse event data were collected at every visit- from baseline, at the first session of each week, and at 13-month follow up (~1.5 years).	3.4% 2/58 • Adverse event data were collected at every visit- from baseline, at the first session of each week, and at 13-month follow up (~1.5 years).