NCT04391023

Cerebellar tDCS and Balance Training in PwMS

Completed NA Results posted Last updated 18 June 2024

What this trial tests

NA trial testing Sham Transcranial Direct Current Stimulation (tDCS) in Multiple Sclerosis in 18 participants. Completed in 16 July 2023.

Timeline

26 September 2022

Primary endpoint
16 July 2023

16 July 2023

Quick facts

Lead sponsor	University of Iowa
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	18
Start date	26 September 2022
Primary completion	16 July 2023
Estimated completion	16 July 2023
Sites	1 location across United States

Drugs / interventions tested

• Sham Transcranial Direct Current Stimulation (tDCS)
• Balance Training
• 2 mA Transcranial Direct Current Stimulation
• 4 mA Transcranial Direct Current Stimulation

Conditions studied

• Multiple Sclerosis — all drugs for Multiple Sclerosis →

Sponsor

University of Iowa

Who can join

Adults 18 to 70, any sex, with Multiple Sclerosis. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Score on the Berg Balance Scale Primary · 24 hours, 2 weeks, and 4 weeks post-intervention

The BBS is a valid and reliable assessment of balance during static (e.g., standing with eyes closed) and dynamic conditions (e.g., completing a 360-degree turn) conditions. BBS scores range from 0 to 56. Lower scores indicate increased impairment in balance. A cut-off score of 44 has been established as a criterion to identify PwMS with a high fall risk.

24 hours post-intervention

Group	Value	95% CI
Sham tDCS	54.43	± 2.37
4 mA tDCS	51.43	± 9.11

2-weeks post-intervention

Group	Value	95% CI
Sham tDCS	54.67	± 2.07
4 mA tDCS	50.33	± 10.21

4-weeks post-intervention

Group	Value	95% CI
Sham tDCS	54.29	± 2.56
4 mA tDCS	51.17	± 9.93

Time to Complete the Timed Up and Go Test (TUG) Primary · 24 hours, 2 weeks, and 4 weeks post-intervention

The TUG measures the time it takes for the participant to rise from a chair, walk 3 meters, turn around, walk back to the chair, and sit down. Two trials were completed and the reported score is the average time between the two trials. A higher number means it took the participant more time to complete the task (i.e., worse performance).

24 hours post-intervention

Group	Value	95% CI
Sham tDCS	7.81	± 1.66
4 mA tDCS	7.47	± 3.78

2-week post-intervention

Group	Value	95% CI
Sham tDCS	7.55	± 1.43
4 mA tDCS	6.99	± 3.34

4-weeks post-intervention

Group	Value	95% CI
Sham tDCS	7.10	± 1.23
4 mA tDCS	6.88	± 3.10

Time to Complete the Six Minute Walk Test (6MWT) Secondary · 24 hours, 2 weeks, and 4 weeks post-intervention

Subjects performed the 6MWT in a cordoned-off hallway with two symbols on the ground, placed 30 meters apart. Subjects were instructed to walk as far as possible between the marks for 6 minutes, walking around each symbol like a cone. Higher scores indicate more distance walked (i.e., better performance).

24 hours post-intervention

Group	Value	95% CI
Sham tDCS	464.04	± 107.68
4 mA tDCS	523.31	± 44.70

2-weeks post-intervention

Group	Value	95% CI
Sham tDCS	479.33	± 137.44
4 mA tDCS	542.15	± 91.86

4-weeks post-intervention

Group	Value	95% CI
Sham tDCS	487.44	± 114.10
4 mA tDCS	545.03	± 104.95

Score on the Fatigue Severity Scale (FSS) Secondary · 24 hours, 2-weeks, and 4-weeks post-intervention

The FSS consists of nine statements used to assess perceived fatigability. Subjects are asked to rate how much they felt a statement applied to them, on a 7-point scale (low value = does not apply, high value = high agreement with the statement). The questionnaire is scored by calculating the average response to the statements. Therefore, the scores will range from 1 to 7 (1 = low fatigue, 7 = high fatigue). A score ≥ 4 indicates a clinically significant level of fatigue.

24 hours post-intervention

Group	Value	95% CI
Sham tDCS	4.21	± 1.38
4 mA tDCS	3.62	± 2.11

2-weeks post-intervention

Group	Value	95% CI
Sham tDCS	3.81	± 1.52
4 mA tDCS	4.39	± 1.31

4-weeks post-intervention

Group	Value	95% CI
Sham tDCS	3.60	± 1.51
4 mA tDCS	3.80	± 1.64

Sponsor's own description

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 relapsing-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 relapsing-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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.