Effectiveness of training before unsedated MRI scans in young children: a randomized control trial.

BACKGROUND: Young children requiring clinical magnetic resonance imaging (MRI) may be given general anesthesia. General anesthesia has potential side effects, is costly, and introduces logistical challenges. Thus, methods that allow children to undergo awake MRI scans are desirable. OBJECTIVES: To compare the effectiveness of mock scanner training with a child life specialist, play-based training with a child life specialist, and home book and video preparation by parents to allow non-sedated clinical MRI scanning in children aged 3-7 years. MATERIALS AND METHODS: Children (3-7 years, n=122) undergoing clinical MRI scans at the Alberta Children's Hospital were invited to participate and randomized to one of three groups: home-based preparation materials, training with a child life specialist (no mock MRI), or training in a mock MRI with a child life specialist. Training occurred a few days prior to their MRI. Self- and parent-reported functioning (PedsQL VAS) were assessed pre/post-training (for the two training groups) and pre/post-MRI. Scan success was determined by a pediatric radiologist. RESULTS: Overall, 91% (111/122) of children successfully completed an awake MRI. There were no significant differences between the mock scanner (89%, 32/36), child life (88%, 34/39), and at-home (96%, 45/47) groups (P=0.34). Total functioning scores were similar across groups; however, the mock scanner group had significantly lower self-reported fear (F=3.2, P=0.04), parent-reported sadness (F=3.3, P=0.04), and worry (F=3.5, P=0.03) prior to MRI. Children with unsuccessful scans were younger (4.5 vs. 5.7 years, P<0.001). CONCLUSIONS: Most young children can tolerate awake MRI scans and do not need to be routinely anesthetized. All preparation methods tested, including at-home materials, were effective.

Transcranial direct current stimulation for children with perinatal stroke and hemiparesis.

OBJECTIVE: To determine whether the addition of transcranial direct current stimulation (tDCS) to intensive therapy increases motor function in children with perinatal stroke and hemiparetic cerebral palsy. METHODS: This was a randomized, controlled, double-blind clinical trial. Participants were recruited from a population-based cohort with MRI-classified unilateral perinatal stroke, age of 6 to 18 years, and disabling hemiparesis. All completed a goal-directed, peer-supported, 2-week after-school motor learning camp (32 hours of therapy). Participants were randomized 1:1 to 1 mA cathodal tDCS over the contralesional primary motor cortex (M1) for the initial 20 minutes of daily therapy or sham. Primary subjective (Canadian Occupational Performance Measure [COPM]), objective (Assisting Hand Assessment [AHA]), safety, and secondary outcomes were measured at 1 week and 2 months after intervention. Analysis was by intention to treat. RESULTS: Twenty-four participants were randomized (median age 11.8 ± 2.7 years, range 6.7-17.8). COPM performance and satisfaction scores doubled at 1 week with sustained gains at 2 months (p < 0.001). COPM scores increased more with tDCS compared to sham control (p = 0.004). AHA scores demonstrated only mild increases at both time points with no tDCS effects. Procedures were safe and well tolerated with no decrease in either arm function or serious adverse events. CONCLUSION: tDCS trials appear feasible and safe in hemiparetic children. Lack of change in objective motor function may reflect underdosing of therapy. Marked gains in subjective function with tDCS warrant further study. CLINICALTRIALSGOV IDENTIFIER: NCT02170285. CLASSIFICATION OF EVIDENCE: This study provides Class II evidence that for children with perinatal stroke and hemiparetic cerebral palsy, the addition of tDCS to moderate-dose motor learning therapy does not significantly improve motor function as measured by the AHA.

Brain stimulation and constraint for perinatal stroke hemiparesis: The PLASTIC CHAMPS Trial.

OBJECTIVE: To determine whether the addition of repetitive transcranial magnetic stimulation (rTMS) and/or constraint-induced movement therapy (CIMT) to intensive therapy increases motor function in children with perinatal stroke and hemiparesis. METHODS: A factorial-design, blinded, randomized controlled trial (clinicaltrials.gov/NCT01189058) assessed rTMS and CIMT effects in hemiparetic children (aged 6-19 years) with MRI-confirmed perinatal stroke. All completed a 2-week, goal-directed, peer-supported motor learning camp randomized to daily rTMS, CIMT, both, or neither. Primary outcomes were the Assisting Hand Assessment and the Canadian Occupational Performance Measure at baseline, and 1 week, 2 and 6 months postintervention. Outcome assessors were blinded to treatment. Interim safety analyses occurred after 12 and 24 participants. Intention-to-treat analysis examined treatment effects over time (linear mixed effects model). RESULTS: All 45 participants completed the trial. Addition of rTMS, CIMT, or both doubled the chances of clinically significant improvement. Assisting Hand Assessment gains at 6 months were additive and largest with rTMS + CIMT (ß coefficient = 5.54 [2.57-8.51], p = 0.0004). The camp alone produced large improvements in Canadian Occupational Performance Measure scores, maximal at 6 months (Cohen d = 1.6, p = 0.002). Quality-of-life scores improved. Interventions were well tolerated and safe with no decrease in function of either hand. CONCLUSIONS: Hemiparetic children participating in intensive, psychosocial rehabilitation programs can achieve sustained functional gains. Addition of CIMT and rTMS increases the chances of improvement. CLASSIFICATION OF EVIDENCE: This study provides Class II evidence that combined rTMS and CIMT enhance therapy-induced functional motor gains in children with stroke-induced hemiparetic cerebral palsy.