High-dose theta-burst stimulation is safe and efficacious in improving upper extremity motor function in patients with stroke, according to study findings published in Stroke.

Study authors conducted a sham-controlled, parallel-group, 3-arm randomized clinical trial between June 2021 and June 2022 to explore the safety and efficacy of high-dose theta-burst stimulation for poststroke upper extremity motor function recovery. Patients aged 18 to 70 who had a first-time stroke, were at least 1 month post-onset, and had unilateral limb motor impairment were randomly assigned 2:2:1:1 to receive 3 weeks (5 days per week, 3 sessions per day) of treatment with intermittent theta-burst stimulation to the ipsilesional upper extremity sensorimotor network (iTBS group), continuous theta-burst stimulation to the contralesional upper extremity sensorimotor network (cTBS group), or sham stimulation (sham-iTBS and sham-cTBS groups). Baseline assessments of vital signs, clinical characteristics, and magnetic resonance imaging (MRI) scans were conducted prior to patients’ receipt of intervention. Neuropsychologic assessments were conducted at baseline, 1 week, and 3 weeks using the Fugl-Meyer assessment (FMA), Wolf Motor Function Test, grip strength, functional ambulatory category, modified Barthel index, and Stroke Impact Scale. Analysis of covariance was used to evaluate the primary outcome of upper extremity function recovery, which was measured as the changes in FMA-upper extremity score from baseline to week 1 to week 2.

Our findings highlight the potential of incorporating a neuroimaging-guided individual targeting strategy with high-dose iTBS and cTBS for poststroke UE motor function rehabilitation and overall quality of life improvement.

A total of 43 patients were included in the final analysis, of whom 15 (mean age, 50.6; women, 20%; mean months poststroke, 3.62) were assigned to the iTBS group, 14 (mean age, 48.36; women, 21.4%; mean months poststroke, 4.49) were assigned to the cTBS group, and 14 (mean age, 53.57; women, 14.3%; mean months poststroke, 2.79) comprised the sham group.

At 3 weeks, a significantly greater effect was observed in the iTBS vs sham group (mean difference [MD], 8.54; 95% CI, 4.39-12.70; P <.001), indicative of a greater therapeutic effect. This superior effect was also demonstrated at week 1 (MD, 4.15; 95% CI, 1.24-7.06; P =.003).

Similarly, the cTBS vs sham group was also associated with a superior effect at both week 1 (MD, 3.88; 95% CI, 0.84-6.92; P =.008) and week 3 (MD, 8.74; 95% CI, 4.41-13.07; P <.001). 

More patients in the iTBS (60%) and cTBS (64.3%) groups vs sham (0.0%) group exhibited clinically significant responses as demonstrated by the minimal clinically important differences in FMA-upper extremity. A higher response rate was consistently found in the active groups vs the sham group at a wide range (6-13) of minimal clinically important different cutoff values.

Adverse events (AEs) were rare, mild, and occurred at similar frequencies across all groups. Transient scalp numbness was reported by 2 participants, 1 who was assigned to the iTBS group and 1 who was assigned to the cTBS group. Another patient in the cTBS group reported mild fatigue. All AEs occurred after stimulation at the first-time intervention and subsided by day 2.

Study limitations include the single-center design, small sample sizes, the exclusion of a considerable portion of the stroke population due to the upper age limit, and implementation of strict anti-COVID-19 regulations during the study period.

“Our findings highlight the potential of incorporating a neuroimaging-guided individual targeting strategy with high-dose iTBS [intermittent theta-burst stimulation] and cTBS [continuous theta-burst stimulation] for poststroke UE [upper extremity] motor function rehabilitation and overall quality of life improvement,” the study authors concluded.

Disclosure: Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures. 

Tang Z, Huang J, Zhou Y, et al. Efficacy and safety of high-dose TBS on post-stroke upper extremity motor impairment: a randomized controlled trial. Stroke. 2024;55(9):2212-2220. doi:10.1161/STROKEAHA.124.046597