None listed
Conditions
Brief summary
Multiple sclerosis (MS) is the most frequent neurological disease in young and middle-aged adults in Australia and has a lifelong impact. Abnormalities in gait and balance are common in patients with MS. A number of different mechanisms are known to contribute to recovery from neural injury and relapses in MS. Functional imaging studies suggest that cortical plasticity and reorganization can promote recovery from brain injury in MS (Reddy et al. 2000; Pantano et al. 2002; Rocca et al. 2010, 2002). Balance training is an important rehabilitation intervention for MS patients, and most studies show a small, but significant, effect of physiotherapy on balance in people with multiple sclerosis who have a mild to moderate level of disability (Lord et al. 1998; Cattaneo et al. 2007a; Paltaama et al. 2012). Non-invasive brain stimulation (NIBS) is being increasingly trialled for enhancing brain plasticity after neural injury and shows promising results in patients with stroke, dystonia and Parkinson's disease (Edwardson et al. 2012; Ridding and Rothwell, 2007). Brain stimulation can be used to excite the brain and promote relearning. This study aims to recruit MS patients who have mild to moderate difficulty with balance and walking. We will evaluate if brain stimulation (transcranial direct current stimulation – tDCS) added to a structured balance training program will provide added benefit in mobility. This will be in addition to their regular outpatient therapy program prescribed by their physicians. This study will recruit patients with MS who have mild to moderate impairment of balance and walking. They will be randomly split into two groups: Both groups will complete a structured balance training program (1 hour sessions, 2 days a week for 6 weeks). Group 1 will also receive brain stimulation (tDCS) prior to each balance therapy session, while Group 2 will receive a sham-tDCS session. A physiotherapist who is not involved in the treatment will test each patient's balance and walking, as well as administering some questionnaires and a cognitive test. These assessments will be done before the treatment commences, immediately after the 6 week program and 6 months, 12 months and 24 months after the initial assessment date.
Interventions
Participants will receive 12 treatment sessions over 6 weeks (2 per week) at the Perron Institute. Each treatment will comprise brain stimulation (real or sham tDCS) for 20 minutes followed by ~ 1 hour of one on one supervised balance therapy provided by a neurophysiotherapist. tDCS will be administered by a trained physiotherapist or clinical psychologist.
Transcranial direct current stimulation (tDCS) is a non-invasive technique that changes the excitability of brain cells by applying a weak
Participants will receive 12 treatment sessions over 6 weeks (2 per week) at the Perron Institute. Each treatment will comprise brain stimulation (real or sham tDCS) for 20 minutes followed by ~ 1 hour of one on one supervised balance therapy provided by a neurophysiotherapist. tDCS will be administered by a trained physiotherapist or clinical psychologist. Transcranial direct current stimulation (tDCS) is a non-invasive technique that changes the excitability of brain cells by applying a weak direct current (1-2mA) to the brain. The method of applying tDCS involves placing saline-soaked sponge electrodes onto the skin of the scalp. These electrodes are connected to a battery driven direct current stimulator. tDCS is painless, inexpensive, has no major adverse effects and is easy to apply clinically. Each balance training session will be one hour in duration and will comprise the 2 balance treatments described below. A rest break (5-10 minutes) will be given between the 2 treatments to minimize fatigue. Treatment 1 (25 minutes). Impairment based physiotherapy would specifically target problems identified on assessment. This would include poor posture, reduced range of passive and active joint movement, reduced lower limb and core strength, use of compensatory movements, overactivity on one side etc. Treatment 2 (25 minutes). Task oriented functional therapy which would progress tasks in difficulty and repetition as performance improved. Tasks would include standing, stepping, turning, reaching, hopping, running and walking tasks, including steps and uneven surfaces. tDCS has been shown to improve motor function in stroke but has not been trialled in MS. Another kind of brain stimulation (rTMS) has been shown to benefit hand dexterity and lower limb spasticity in MS (Koch et al. 2008: Centoze et al. 2007). This study will use anodal tDCS, which increases brain excitability, and 2mA tDCS will be applied for 20 minutes prior to balance therapy.
Sponsors
Clinical Professor Soumya Ghosh
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Adults (>18 years old) with definite diagnosis of Multiple Sclerosis (Relapsing Remitting, Secondary Progressive or Primary Progressive) 2. Mild to moderate balance impairment a. Symptoms of gait or balance impairment (including falls) b. Medical and physiotherapy assessment suggestive of balance impairment 3. EDSS < 6 a. Able to walk at least 20m, +/ aid (need to be able to complete 10 Meter Walk Test and Dynamic Gait Index) b. Able to stand independently for at least 10 minutes (to complete the Sensory Organization Test on the Balance Master) c. Can step up and down 1 step with a maximum of 1 person assist
Exclusion criteria
1. Recent relapse (last 1 month) 2. Significant medical comorbidities that would reduce exercise tolerance and rehabilitation potential such as heart failure, unstable angina etc. 3. Significant psychiatric comorbidities, such as depression, anxiety 4. History of seizures, epilepsy or unexplained loss of consciousness 5. Cognitive impairment 6. Moderate to severe back or lower limb pain 7. Lower limb injury including orthopaedic injuries/complaints precluding participation 8. Presence of magnetically or electrically sensitive implants such as cardiac pacemakers, stimulators and pumps, cochlear implants etc. 9. To minimise potential risks, all participants will be thoroughly screened for tDCS/TMS risk factors twice: prior to enrolment and immediately prior to the experimental session
Outcome results
None listed