None listed
Conditions
Brief summary
The aim of this pilot study is to assess the feasibility, acceptability and potential effectiveness of cerebellar transcranial Direct Current Stimulation (tDCS), a non-invasive brain stimulation technique, combined with physical therapy programme on ataxic symptoms experienced by people with Spinocerebellar ataxia type 1 (SCA1). It is hypothesized that cerebellar tDCS combined with a physical therapy programme will improve ataxia compared to sham cerebellar tDCS combined with a physical therapy programme in people with SCA1.
Interventions
The study involves participants completing 12 intervention sessions (exercise based standardised rehabilitation sessions+anodal tDCS) over a 4 week period (ie., 3 sessions per week). Each exercise based session will take up to 1 hour and will be delivered (one-on-one basis) at the physiotherapy clinic or participant's home, as required. The exercise based session will comprise of a tailored exercise programme aimed at improving postural control, gait speed and dual task performance in complex ga
The study involves participants completing 12 intervention sessions (exercise based standardised rehabilitation sessions+anodal tDCS) over a 4 week period (ie., 3 sessions per week). Each exercise based session will take up to 1 hour and will be delivered (one-on-one basis) at the physiotherapy clinic or participant's home, as required. The exercise based session will comprise of a tailored exercise programme aimed at improving postural control, gait speed and dual task performance in complex gait and balance tasks done under supervision of an experienced physiotherapist. The exercises will include treadmill walking, upper and lower limb static cycling, bridging, 4 point kneeling, high kneeling, sit to stand, press ups, lateral lunges, standing with feet apart, feet together and tandem standing, ball reach and throws, lower limb stretching etc. Transcranial direct current stimulation (tDCS) will be delivered using a battery-driven constant-current stimulator from Soterix Medical. Saline soaked sponge electrodes (5cmx7cm) will be used with the anode placed over the cerebellum (2cm below the inion) and the reference electrode (cathode) over the right deltoid muscle (Parazzini et al 2014; Grimaldi et al 2014). Electrodes will be secured using elastic straps. The Soterix tDCS device will be set to deliver a 2mA current (equates to a 0.06mA/cm2) for 20 minutes. Anodal tDCS at 2mA stimulus will be used in combination with a standardised rehabilitation programme and will be delivered during the first 20 minutes of the rehabilitation program. An independent research assistant will set the tDCS stimulator to ‘sham’ condition or ‘real’ condition. Adherence to/fidelity of the intervention will be assessed by keeping a record of session attendance and whether the intervention is delivered as per the planned protocol. There will be a three month washout period between the intervention and control session.
Sponsors
Auckland University of Technology
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
Ten participants aged between 18 and 70 with confirmed SCA1 will be recruited through the Neurogenetics Research Clinic. Inclusion criteria: • confirmed genetic test • independently mobile with or without walking aids (able to walk 10m) • able to give consent,
Exclusion criteria
• do not have any medical conditions such as epilepsy, unexplained recurring headaches and cardiac arrhythmias which may influence the results • do not have history of epilepsy, head injury or concussion in the last six months • do not have a skull fracture or other known skull defects • do not have any metal implants or pacemakers • do not have migraine headaches or Meniere’s disease
Outcome results
None listed