Concurrent transcranial direct current stimulation and progressive resistance training in Parkinson's disease: study protocol for a randomised controlled trial

Abstract

Background: Parkinson's disease (PD) results from a loss of dopamine in the brain, leading to movement dysfunctions such as bradykinesia, postural instability, resting tremor and muscle rigidity. Furthermore, dopamine deficiency in PD has been shown to result in maladaptive plasticity of the primary motor cortex (M1). Progressive resistance training (PRT) is a popular intervention in PD that improves muscular strength and results in clinically significant improvements on the Unified Parkinson's Disease Rating Scale (UPDRS). In separate studies, the application of anodal transcranial direct current stimulation (a-tDCS) to the M1 has been shown to improve motor function in PD; however, the combined use of tDCS and PRT has not been investigated.

Methods/design: We propose a 6-week, double-blind randomised controlled trial combining M1 tDCS and PRT of the lower body in participants (n = 42) with moderate PD (Hoehn and Yahr scale score 2-4). Supervised lower body PRT combined with functional balance tasks will be performed three times per week with concurrent a-tDCS delivered at 2 mA for 20 minutes (a-tDCS group) or with sham tDCS (sham group). Control participants will receive standard care (control group). Outcome measures will include functional strength, gait speed and variability, balance, neurophysiological function at rest and during movement execution, and the UPDRS motor subscale, measured at baseline, 3 weeks (during), 6 weeks (post), and 9 weeks (retention). Ethical approval has been granted by the Deakin University Human Research Ethics Committee (project number 2015-014), and the trial has been registered with the Australian New Zealand Clinical Trials Registry (ACTRN12615001241527).

Discussion: This will be the first randomised controlled trial to combine PRT and a-tDCS targeting balance and gait in people with PD. The study will elucidate the functional, clinical and neurophysiological outcomes of combined PRT and a-tDCS. It is hypothesised that combined PRT and a-tDCS will significantly improve lower limb strength, postural sway, gait speed and stride variability compared with PRT with sham tDCS. Further, we hypothesise that pre-frontal cortex activation during dual-task cognitive and gait/balance activities will be reduced, and that M1 excitability and inhibition will be augmented, following the combined PRT and a-tDCS intervention.

Trial registration: Australian New Zealand Clinical Trials Registry ACTRN12615001241527 . Registered on 12 November 2015.

Keywords: Balance; Gait; Neuroplasticity; Non-invasive brain stimulation; Parkinson’s disease; fNIRS.

Fig. 1

Flow diagram of recruitment, screening and randomisation process. a-tDCS anodal transcranial direct current stimulation

Fig. 2

Study timeline (a) and Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT 2013) diagram (b) illustrate the schedule of enrolment, interventions and assessments. fNIRS functional near-infrared spectroscopy, FTSTS Five Times Sit-to-Stand Test, PRT progressive resistance training, tDCS transcranial direct current stimulation, TMS transcranial magnetic stimulation, TUG Timed Up and Go Test, UPDRS Unified Parkinson’s Disease Rating Scale

Fig. 3

Example of seated leg press

Fig. 4

Example of body weight squat

Fig. 5

Example of standing bilateral calf raise

Fig. 6

Example of unilateral dorsiflexion with free-weight dumb-bell

Fig. 7

Example of electrode montage for anodal transcranial direct current stimulation