Cerebellar tDCS and Balance Training in PwMS
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional

Summary: 
      Many people with multiple sclerosis (PwMS) have decreased balance and postural control, gait
      deficits, and a high frequency of falls. High fall rates and mobility impairments pose a
      significant risk to the independence and quality of life of PwMS. Therefore, effective
      interventions to improve balance and postural control are urgently needed to decrease the
      frequency of falls in PwMS. Balance training has been demonstrated to significantly improve
      postural control and gait in PwMS. One possible treatment modality to amplify the effects of
      balance training is transcranial direct current stimulation (tDCS), a non-invasive means to
      increase cortical excitability and potentially prime the brain for task specific learning.
      The cerebellum plays a vital role in balance and posture and may be an important target
      structure for tDCS studies seeking to reduce fall risk. Studies have shown that anodal
      cerebellar tDCS is effective in improving balance control in older adults with high fall risk
      and patients with chronic stroke. However, the most effective tDCS intensity and the duration
      of the effects on balance control has not been established. Moreover, no study has combined
      cerebellar tDCS and balance training to reduce fall risk in PwMS. The purpose of this study
      is to investigate the effects of cerebellar transcranial direct current stimulation (tDCS) on
      fall risk in people with relasping-remitting multiple sclerosis. We will conduct tDCS or SHAM
      followed by balance training on 4 consecutive days. We will evaluate fall risk with
      well-established functional tasks, such as the Berg Balance Scale, Timed Up and Go (TUG), the
      six minute walk test (6MWT), and static posturography.

      Prospective participants, men and women with relasping-remitting MS, will be recruited. To
      accomplish this study, 30 participants will be randomly assigned into 3 groups (2 mA tDCS, 4
      mA tDCS, or SHAM). This study involves 4 daily visits at the Integrative Neurophysiology Lab
      at the same time of day for each subject and three follow-up visits. The duration of visit 1
      will be approximately 2.5 hours and the duration of visits 2-4 will be approximately 1.5
      hours. Visit 5, 6, and 7 will be approximately 24 hours, 1 week, and 3 weeks, respectively,
      after visit 4 and will last approximately 1.5 hours. During tDCS sessions, participants will
      undergo either Sham, 2 mA, and 4 mA tDCS for 20 minutes followed by balance training.
    


Intervention name(s): Sham Transcranial Direct Current Stimulation (tDCS); Balance Training; 2 mA Transcranial Direct Current Stimulation; 4 mA Transcranial Direct Current Stimulation
Intervention type(s): Device; Behavioral; Device; Device
Intervention description(s): tDCS is a non-invasive brain stimulation technique in which a very weak electrical current (2 mA) is applied to the scalp at the beginning of the session and then remains at 0 mA for the duration of the session to control for placebo-like effects. The anode and cathode will both be placed over the cerebellum.; The balance training protocol will include balance training exercises on both compliant (i.e., foam pad and trampoline) and firm surfaces.; tDCS is a non-invasive brain stimulation technique in which very weak electrical current (2 mA) is applied to the scalp for 20 minutes. The anode and cathode will both be placed over the cerebellum.; tDCS is a non-invasive brain stimulation technique in which very weak electrical current (4 mA) is applied to the scalp for 20 minutes. The anode and cathode will both be placed over the cerebellum.
Other intervention name(s): tDCS; tDCS; tDCS
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Brain Stimulation; Balance Training