Author Year

Country

Study Design

Sample Size

Mahalick et al. (1998)

USA

RCT

PEDro=8

N=14

Population: TBI; Mean Age=10.7yr; Gender: Male=11, Female=3; Mean Time Post Injury=14.1mo; Mean GCS=6.9.

Intervention: Patients were randomly assigned to receive either methylphenidate or placebo (lactose) for 2 wk before crossing over conditions. Methylphenidate was administered in a dose of 0.3 mg/kg 2x/d at 8 am and 12 pm, for 14 d. Assessments were conducted 1wk into each phase.

Outcome Measure: Gordon Diagnostic System (GDS), Woodcock-Johnson Psychoeducational Test Battery-Revised (WJPTB-R), Ruff 2 and 7 Cancellation Test (7 CT).

1.       Patients significantly improved on GDS measures of delayed efficiency (impulsivity), vigilance and distractibility (p<0.005, p<0.020 and p<0.020 respectively) during the methylphenidate phase compared to the placebo phase.

2.       Attentional processing performance on the WJPTB-R was also significantly improved during the methylphenidate phase (p<0.040) compared to the placebo phase.

3.       Selective and sustained attention also significantly improved on both Ruff 2 and 7 CT subscales of letter and number processing during the methylphenidate phase compared to the placebo phase (p<0.010, p<0.001 respectively).

Williams et al. (1998)

USA

PEDro=8

N=10

Population: TBI; Mean Age=10.4yr; Gender: Male=9, Female=1; Mean Time Post Injury=2.8 yr.

Intervention: Patients were randomly assigned to receive either methylphenidate or placebo for 2wk before crossing over. Methylphenidate was administered 2x/d for 4 d, followed by a 3 d washout period. Dosage depended on patient weight with patients <20 kg receiving 5 mg, 21-29 kg receiving 7.5 mg and patients >30 kg receiving 10mg. Assessments were conducted at the start and end of each week.

Outcome Measure: Conners Rrating Scale, Symbol Digit Modalities Test, Continuous Performance Test, Sternberg Memory and Reaction Time Task, Sentence Repetition Task, Rapid Automatized Naming Test, Developmental Test of Visual-Motor Integration, Finger Tapping Test, Purdue Pegboard.

1.       No significant differences were found on any of the measures between groups (p>0.050).

Ekinci et al. (2017)

Turkey

Pre-Post Test

N=40

Population: TBI=20, 1^o ADHD=20; Mean Age=12.7yr; Gender: Male=27, Female=13.

Intervention: Patients received immediate-release methylphenidate (IR-MPH). Dosage started at 5 mg 2x/d and was increased to 10 mg 2 x/day and 3 x/day at the first and second week, respectively. Measurements were taken at baseline and after 8 wk.

Outcome Measure: Turgay DMS- IV Disruptive Behavior Disorders Rating Scale parent and teacher forms (T-DSM-IV-S), Conners’ Parent Rating Scale (CPRS), Conners’ Teacher Rating Scale-Revised (CTRS-R), The Clinical Global Impression-Severity and Improvement Scales (CGI-S), Adverse Effect Scale.

1.       In children with TBI, most scores on T-DSM-IV-S, CPRS CGI-S, and CTRS-R improved significantly after IR-MPH treatment (p<0.050).

2.       Ninety-five percent of patients reported no adverse effects, or mild adverse effects.

Nikles et al. (2014)

Australia

Pre-Post

N=10

Population: TBI; Mean Age=12.9yr; Gender: Male=6, Female=4; Mean Time Post Injury=6.1yr; Mean GCS=8.3.

Intervention: Patients were randomized to receive either a stimulant (methylphenidate or dexamphetamine) or a placebo for three cycles of 1wk each. The intervention was provided for 6wk in total. Assessments were conducted weekly after each 1wk trial.

Outcome Measure: Conners’ 3 Parent Rating Scales (C3PR), Conners’ 3 Teacher Rating Scales (C3TR), Behaviour Rating Inventory of Executive Function (BRIEF), Eyberg Child Behaviour Inventory (ECBI).

1.       A trend towards improved ADHD behaviour was noted on the C3TR in favour of the stimulant group, however this was not statistically significant.

2.       A less pronounced difference was noted on the C3PR in favour of stimulants compared to placebo, however this was not statistically significant.

3.       Teacher-reported intensity and parent-reported frequency of problem behaviours on the ECBI during stimulant cycles were reduced compared to placebo cycles, however this was not statistically significant.

4.       Teacher-reported and parent-reported BRIEF scores revealed a mean score difference of 20.7 and 10.8 respectively in favour of the stimulant cycles but this did not reach statistical significance.

Hornyak et al. (1997)

USA

Case Series

N=10

Population: TBI; Mean Age=10.11yr; Gender: Male=7, Female=3; Mean Time Post Injury=10mo; Mean GCS=6.2.

Intervention: A retrospective review was conducted on medical records for patients who had been treated with methylphenidate. Qualitative assessments of behaviour pre- and post-treatment from parents, teachers, physicians and neuropsychologists were analyzed.

Outcome Measure: Qualitative Observations of Behaviours, Ranchos Los Amigos (RLAS) scale.

1.       Six patients at RLAS Level VII and one patient at RLAS Level IV demonstrated an improvement in attention.

2.       Two patients at RLAS Level VII and one patient at RLAS Level IV demonstrated a decrease in impulsivity.

3.       Two patients at RLAS Level III were found to demonstrate a slight increase in arousability and responsiveness.

4.       No neuropsychometric changes in response to methylphenidate were reported in one patient (RLAS Level VII) but was noted to be more attentive and calmer in class.