NCT03658668

Combined Effect of Transcranial Direct Current Stimulation (tDCS) and Physical Activity on Gait and Functional Mobility in Participants With Multiple Sclerosis

Completed NA Results posted Last updated 16 August 2023

What this trial tests

NA trial testing active tDCS in Multiple Sclerosis in 23 participants. Completed in 10 June 2021.

Timeline

3 October 2018

Primary endpoint
10 June 2021

10 June 2021

Quick facts

Lead sponsor	NYU Langone Health
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	23
Start date	3 October 2018
Primary completion	10 June 2021
Estimated completion	10 June 2021
Sites	1 location across United States

Drugs / interventions tested

• active tDCS
• sham tDCS
• Physical Activity (PA)

Conditions studied

• Multiple Sclerosis — all drugs for Multiple Sclerosis →

Sponsor

NYU Langone Health — full company profile →

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.

Change in Gait Velocity Primary · Baseline, Follow-Up Visit (3 days after final treatment session, up to 4 weeks)

Measured by a 10 meter walk test using wearable inertial sensors

Group	Value	95% CI
Active tDCS+PA	0.33	± 0.32
Sham tDCS+PA	0.01	± 0.33

Change in Stride Length Primary · Baseline, Follow-Up Visit (3 days after final treatment session, up to 4 weeks)

Measured by a 10 meter walk test using wearable inertial sensors

Group	Value	95% CI
Active tDCS+PA	0.32	± 0.17
Sham tDCS+PA	-0.02	± 0.2

Percent of tDCS Sessions Completed Secondary · End of Final Treatment Session (Up to Week 3)

Group	Value	95% CI
Active tDCS+PA	100	± 0
Sham tDCS+PA	100	± 0

Change in 12-item Multiple Sclerosis Walking Scale Score Secondary · Baseline, Follow-Up Visit (3 days after final treatment session, up to 4 weeks)

12-item questionnaire assessing how multiple sclerosis (MS) affects walking abilities. Items are ranked on a scale from 1 (not at all) to 5 (extremely). The total score is the sum of responses and ranges from 12 to 60; higher scores indicate greater impact of MS on walking abilities.

Group	Value	95% CI
Active tDCS+PA	-4.9	± 3.2
Sham tDCS+PA	-2.5	± 2.9

Change 21-item Modified Fatigue Impact Scale Score Secondary · Baseline, Follow-Up Visit (3 days after final treatment session, up to 4 weeks)

21-item questionnaire assessing how fatigue may affect a person. Items are ranked on a scale from 0 (never) to 4 (almost always). The total score is the sum of responses and ranges from 0 to 84; scores indicate greater impact of fatigue.

Group	Value	95% CI
Active tDCS+PA	-12.4	± 10.4
Sham tDCS+PA	1.6	± 8.7

Adverse events — posted to ClinicalTrials.gov

Time frame: 10 days. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Active tDCS+PA

Serious: 0/13 (0%)

Deaths: 0/13

Sham tDCS+PA

Serious: 0/9 (0%)

Deaths: 0/9

Other adverse events (3 terms — click to expand)

Reaction	System	Active tDCS+PA	Sham tDCS+PA
Tingling at the electrode site	General disorders	—	—
Itching at the electrode site	General disorders	—	—
Warmth Sensation at the electrode site	General disorders	—	—

Data from ClinicalTrials.gov NCT03658668 adverse events section.

Sponsor's own description

This study is aimed to test the efficacy of transcranial direct current stimulation (tDCS) combined with a physical activity (PA) program, in 80 individuals affected by Multiple Sclerosis (MS). In particular, this study will evaluate the efficacy of tDCS when administered simultaneously with PA on walking, functional mobility, and fatigue.

The subjects enrolled will be randomly assigned to the active group (active tDCS+PA) or the sham group (sham tDCS+PA).

Portions of this study may be completed remotely.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Walking in multiple sclerosis improves with tDCS: a randomized, double-blind, sham-controlled study.
   Pilloni G, Choi C, Shaw MT, Coghe G, et al · · 2020 · cited 38× · PMID 33080122 · DOI 10.1002/acn3.51224
2. Gait and Functional Mobility in Multiple Sclerosis: Immediate Effects of Transcranial Direct Current Stimulation (tDCS) Paired With Aerobic Exercise.
   Pilloni G, Choi C, Coghe G, Cocco E, et al · · 2020 · cited 27× · PMID 32431658 · DOI 10.3389/fneur.2020.00310
3. Synaptic Plasticity in Neurodegenerative Diseases: Impact of Exercise as Promising Therapeutic Tool.
   Farina G, Fenili G, Paronetto MP, Crescioli C. · · 2026 · PMID 41597271 · DOI 10.3390/cells15020197