The comparative efficacy of theta burst stimulation or functional electrical stimulation when combined with physical therapy after stroke: a randomized controlled trial

Objective:: To study the long-term effectiveness of Theta Burst Stimulation (TBS) or Functional Electrical Stimulation (FES) combined with Physical therapy (PT) as compared to PT alone for improving arm functions in patients with acute stroke.

Design:: Single blind randomized controlled trial.

Setting:: Outpatient clinics and inpatient wards at tertiary care neurology center.

Subjects:: Adult patients with acute middle cerebral artery territory ischemic stroke.

Interventions:: 60 patients were randomized into three groups of 20 each: TBS+PT; FES+PT; and PT alone. TBS group received intermittent TBS of ipsilesional hemisphere and continuous TBS of contralesional hemisphere while FES group received FES of paretic limb, both for four weeks. All groups received supervised physical therapy for four weeks followed by home physiotherapy for one year.

Outcome measures:: Fugl Meyer Assessment upper limb score (FMA-UL) was primary outcome measure. Patients were evaluated at baseline and subsequently at one, three and six months and one year.

Results:: Compared to PT group, mean FMA-UL scores were higher in TBS and FES groups at all follow-ups ( P < 0.001). From baseline to one year, mean (SD) FMA-UL scores increased from 14.9(2.1) to 55.55(2.46) in TBS group, 15.5(1.99) to 55.85(2.46) in FES group, and 14.3(2.2) to 43.3(4.22) in PT group indicating an increase of 273%, 260%, and 203% respectively. There was no difference between FES and TBS groups.

Conclusion:: A four-week intervention with TBS or FES combined with PT produces better long-term arm functions as compared to PT alone in patients with acute stroke.