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Published on: July 2, 2013
Efficacy and safety of high-dose and personalized TBS on post-stroke cognitive impairment: A randomized controlled
Jianxun Ren1, Wenlong Su2, Ying Zhou3
1Changping Laboratory, Beijing, 102206, China.
Background:
Cognitive impairments are prevalent among stroke patients, impacting independent living. While intermittent theta burst stimulation (iTBS) shows potential for rehabilitation, the efficacy of the commonly-used doses remains unsatisfactory.
Objective:
To investigate the efficacy, dose-dependent effect, and safety of high-dose iTBS targeting the individualized frontoparietal cognitive network (FCN) for post-stroke cognitive recovery.
Methods:
In a randomized, sham-controlled, three-arm trial, patients with post-stroke cognitive impairment (PSCI) received 15 days of high-dose (3600 pulses/day), standard low-dose (1200 pulses/day) as an active control, or sham iTBS targeting the individualized FCN, alongside cognitive training. Primary outcome measured changes in global cognition via the Montreal Cognitive Assessment (MoCA). Secondary measures included MoCA response rates and score changes in the Wechsler Memory Scale, Wechsler Adult Intelligence Scale, and Mini-Mental State Examination.
Results:
Of forty-five randomized participants, forty-one (8 women; mean [SD] age, 58.63 [8.64] years) were analyzed. Personalized targeting improved focality by 33.0 % over the standard F3 target in E-field analysis. Both high-dose and standard low-dose groups showed significant improvements in MoCA. Importantly, the high-dose group demonstrated superior cognitive recovery over both the active control group (estimated difference = 2.50, p = 0.0339, 95 % CI = 0.15-4.84) and the sham control group (estimated difference = 4.29, p = 0.0001, 95 % CI = 1.99-6.60), indicating a superior effect of high-dose stimulation for cognitive recovery. Similar high-dose and dose-dependent effects were observed in other secondary outcomes, suggesting consistent effects on the memory, intelligence, and mental state. No serious adverse events occurred.
Conclusions:
This study highlights the efficacy and safety of high-dose iTBS targeting the individualized FCN for post-stroke cognitive recovery.
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