None listed
Conditions
Brief summary
Stroke survivors with severe upper limb paresis have the poorest functional prognosis. There is growing evidence of the benefits of repetitive training to promote recovery of upper limb function. In addition, there is accumulating evidence that non-invasive brain stimulation techniques, such as tRNS, can augment activity within the cortical areas that are engaged during various forms of training. The aim of this study is to investigate the therapeutic and neuroplastic effects of combining repetitive training with tRNS in stroke survivors with chronic and severe upper limb paresis. A triple-blind randomised controlled pilot trial will be conducted. Ten stroke survivors will be randomly allocated to 4-weeks of SMART Arm training with active tRNS or sham-tRNS. To determine the clinical benefit, all participants will be assessed pre- and post-training and 2-months follow-up using a range of impairment, activity, participation and quality of life measures. To determine the structural (DTI) and functional (resting state fMRI) connectivity of cortical motor regions, all participants will undergo a 3T MRI pre- and post-training.
Interventions
The intervention group will receive 12 x 45-minute training sessions with a physiotherapist (trainer) over 4-weeks (3 sessions per week). Individualised training will involve repetitive and incrementally progressed task-oriented reaching in sitting. Participants will be instructed to push their arm along a linear slide at a comfortable speed while receiving real-time visual feedback of performance. To augment full range movement, electrical stimulation to muscles of the arm will be applied as re
The intervention group will receive 12 x 45-minute training sessions with a physiotherapist (trainer) over 4-weeks (3 sessions per week). Individualised training will involve repetitive and incrementally progressed task-oriented reaching in sitting. Participants will be instructed to push their arm along a linear slide at a comfortable speed while receiving real-time visual feedback of performance. To augment full range movement, electrical stimulation to muscles of the arm will be applied as required using the Empi 300PV unit (St Paul, MN, USA). Stimulation parameters will consist of a 1 second ascending ramp, and a 4 to 20 second duration of 200-sec pulse width biphasic stimulation at 35 Hz. All training will be recorded by the trainer in a logbook. Training will be combined with transcranial random noise stimulation (tRNS). Stimulation will occur for the first 5-seconds of each movement attempt to augment voluntary motor drive. Stimulation will be delivered by a battery-driven non-invasive brain stimulator (Neuroconn, Germany) through conductive rubber electrodes, placed in saline soaked sponges. The noise signal will contain all frequencies (101 – 640 Hz) up to half the sampling rate (1280 sps). The electrodes will be positioned over C3/C4 as per the 10/20 international system for EEG electrode placement: the stimulation electrode positioned over the ipsilesional primary motor cortex (M1) and the reference electrode positioned over the contralateral supra-orbital region. All tRNS parameters will be recorded in a separate log by an unblinded intervener. The stimulating unit will be placed out of sight of the participant and trainer at all times.
Sponsors
Dr Kathryn Hayward
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
All participants will be first time adult (greater than 18 years) stroke survivors who are 6 to 24 months post stroke who demonstrate severe upper limb paresis (as indicated by a Motor Assessment Scale item 6 score of less than 4 out of a possible 6 points). A minimum level of active movement consistent with a triceps brachii score of 2- is required, along with the ability to understand single stage commands. All participants will not have participated in any rehabilitation services for their arm for at least 2-weeks prior to commencement of training.
Exclusion criteria
Exclusion criteria include: 1) any contraindications to tRNS or MRI, 2) presence of neurological conditions other than stroke e.g., Parkinson’s disease, or upper limb comorbidities that could limit functional recovery e.g., arthritis, 3) elbow contracture greater than 15 degrees, or 4) currently taking medication/s that could alter cortical excitability (e.g., antiepileptic medications, antidepressants) or have a presumed positive or negative effect on neural plasticity (e.g., dopamine, dexamphetamine).
Outcome results
None listed