Combined Effect of Transcranial Direct Current Stimulatio... | NCT03658668

NCT03658668

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Label	Type	Description	Intervention Names
active tDCS+PA	Experimental		Device: active tDCS Other: Physical Activity (PA)
sham tDCS+PA	Sham Comparator		Device: sham tDCS Other: Physical Activity (PA)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
active tDCS	Device	tDCS is a therapeutic treatment that utilizes low amplitude direct currents (<4 mA) to induce changes in cortical excitability.	active tDCS+PA

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in Gait Velocity	Measured by a 10 meter walk test using wearable inertial sensors	Baseline, Follow-Up Visit (3 days after final treatment session, up to 4 weeks)
Change in Stride Length	Measured by a 10 meter walk test using wearable inertial sensors	Baseline, Follow-Up Visit (3 days after final treatment session, up to 4 weeks)

Secondary Outcomes

Measure	Description	Time Frame
Percent of tDCS Sessions Completed		End of Final Treatment Session (Up to Week 3)
Change in 12-item Multiple Sclerosis Walking Scale Score	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.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Stable and continuous access to internet service at home
Adequate home facilities (enough space, access to quiet and distraction free area)
Definite MS diagnosis, subtype relapsing-remitting (RR-MS)
Disability Status Scale (EDSS) from 1 to 6.5 with clinically significant gait deviations
Clinically stable and stable on treatment with disease modifying agents at least from 6 months
Able to independently walk with or without an assisting device (i.e. cane, crutches or walking frames) for medium-long distance
Absence of other associated medical conditions that would prevent participants from performing physical activity, such as cardiorespiratory and severe osteoarticular disorders
Able to use study equipment
Able to commit 10 consecutive daily sessions of tDCS while performing physical program with baseline and follow-up visits
Able to understand the informed consent process and provide consent to participate in the study

Exclusion Criteria:

Visual, auditory and motor deficits that would prevent full ability to understand study, as judged by treating neurologist or study staff
Primary psychiatric disorder that would influence ability to participate
Receiving current treatment for epilepsy
Uncontrolled headaches and migraines. In addition, if a subject has had a change in the rate or severity of head pressure, headache, or migraine in the past two weeks, they are excluded
History of head trauma (e.g., head injury, brain surgery) or medical device implanted in the head (such as Deep Brain Stimulator) or in the neck (such as a Vagus Nerve Stimulator)
Any skin disorder/sensitive skin (e.g., eczema, severe rashes), blisters, open wounds, burn including sunburns, cuts or irritation, or other skin defects which compromise the integrity of the skin at or near stimulation locations (where electrodes are placed)
Treatment for a communicable skin disorder currently or over the past 12 months
History of uncontrolled or labile hypertension
Other serious uncontrolled medical condition (e.g. cancer or acute myocardial infarction)
Wide Range Achievement Test-4th Edition (WRAT-4) Reading Recognition score < 85
History of clinically significant abnormalities on electrocardiogram (EKG)
Presence of chronic medical illness and/or severe ataxia
Botulinum toxin injection within the past 4 months or functional surgery in the past 6 months
Alcohol or other substance use disorder
Pregnant or breastfeeding

Contacts/Locations Module

Name	Affiliation	Role
Leigh Charvet, MD	NYU Langone Health	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
New York University School of Medicine		New York	New York	10016	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
32431658	Derived	Pilloni G, Choi C, Coghe G, Cocco E, Krupp LB, Pau M, Charvet LE. Gait and Functional Mobility in Multiple Sclerosis: Immediate Effects of Transcranial Direct Current Stimulation (tDCS) Paired With Aerobic Exercise. Front Neurol. 2020 May 5;11:310. doi: 10.3389/fneur.2020.00310. eCollection 2020.

IPD Sharing Statement Module

No data available

No data is available for this block.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Active tDCS+PA	active tDCS: tDCS is a therapeutic treatment that utilizes low amplitude direct currents (<4 mA) to induce changes in cortical excitability. Physical Activity (PA): 20 minutes of cycling on an ergonomic cross-trainer
FG001	Sham tDCS+PA

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Uploaded Document Information

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Sep 9, 2020

Derived Section

Miscellaneous Info Module

Submission Tracking

Condition Browse Module

Intervention Browse Module

Masking Info

Type of Units Analyzed

Arm/Group Information

ID	Title	Description
BG000	Active tDCS+PA	active tDCS: tDCS is a therapeutic treatment that utilizes low amplitude direct currents (<4 mA) to induce changes in cortical excitability. Physical Activity (PA): 20 minutes of cycling on an ergonomic cross-trainer
BG001	Sham tDCS+PA	sham tDCS: During a sham session, the device is programmed to ramp up to the desired intensity (target 2.5 mA) and ramp down for the initial 60 seconds, with no current delivery during the session, and then again at the end of the session. These brief periods of stimulation serve to mimic the effects of a true stimulation session. Physical Activity (PA): 20 minutes of cycling on an ergonomic cross-trainer
BG002	Total	Total of all reporting groups

Units	Counts
Participants	BG00012 BG0018 BG00220

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00053.4± 12.3 BG00155± 7.55 BG00254.3± 10.3

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG0008 BG0016 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG00010 BG0011 BG002

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0000 BG0010 BG002

Region of Enrollment

Number

participants

Title

Denominators

Categories

United States

Title	Measurements
	BG00012 BG0018 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Change in Gait Velocity

Measured by a 10 meter walk test using wearable inertial sensors

Posted

Mean

Standard Deviation

meters/second (m/s)

Baseline, Follow-Up Visit (3 days after final treatment session, up to 4 weeks)

ID	Title	Description
OG000	Active tDCS+PA	active tDCS: tDCS is a therapeutic treatment that utilizes low amplitude direct currents (<4 mA) to induce changes in cortical excitability. Physical Activity (PA): 20 minutes of cycling on an ergonomic cross-trainer
OG001	Sham tDCS+PA	sham tDCS: During a sham session, the device is programmed to ramp up to the desired intensity (target 2.5 mA) and ramp down for the initial 60 seconds, with no current delivery during the session, and then again at the end of the session. These brief periods of stimulation serve to mimic the effects of a true stimulation session. Physical Activity (PA): 20 minutes of cycling on an ergonomic cross-trainer

Units	Counts
Participants	OG0009 OG0016

Title

Denominators

Categories

Title	Measurements
	OG0000.33± 0.32 OG0010.01± 0.33

Primary

Change in Stride Length

Measured by a 10 meter walk test using wearable inertial sensors

Posted

Mean

Standard Deviation

meters (m)

Baseline, Follow-Up Visit (3 days after final treatment session, up to 4 weeks)

ID	Title	Description
OG000	Active tDCS+PA	active tDCS: tDCS is a therapeutic treatment that utilizes low amplitude direct currents (<4 mA) to induce changes in cortical excitability. Physical Activity (PA): 20 minutes of cycling on an ergonomic cross-trainer
OG001	Sham tDCS+PA	sham tDCS: During a sham session, the device is programmed to ramp up to the desired intensity (target 2.5 mA) and ramp down for the initial 60 seconds, with no current delivery during the session, and then again at the end of the session. These brief periods of stimulation serve to mimic the effects of a true stimulation session. Physical Activity (PA): 20 minutes of cycling on an ergonomic cross-trainer

Units	Counts
Participants	OG000

Secondary

Percent of tDCS Sessions Completed

Posted

Mean

Standard Deviation

Percentage

End of Final Treatment Session (Up to Week 3)

ID	Title	Description
OG000	Active tDCS+PA	active tDCS: tDCS is a therapeutic treatment that utilizes low amplitude direct currents (<4 mA) to induce changes in cortical excitability. Physical Activity (PA): 20 minutes of cycling on an ergonomic cross-trainer
OG001	Sham tDCS+PA	sham tDCS: During a sham session, the device is programmed to ramp up to the desired intensity (target 2.5 mA) and ramp down for the initial 60 seconds, with no current delivery during the session, and then again at the end of the session. These brief periods of stimulation serve to mimic the effects of a true stimulation session. Physical Activity (PA): 20 minutes of cycling on an ergonomic cross-trainer

Units	Counts
Participants	OG000

Secondary

Change in 12-item Multiple Sclerosis Walking Scale Score

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.

Posted

Mean

Standard Deviation

score on a scale

Baseline, Follow-Up Visit (3 days after final treatment session, up to 4 weeks)

ID	Title	Description
OG000	Active tDCS+PA	active tDCS: tDCS is a therapeutic treatment that utilizes low amplitude direct currents (<4 mA) to induce changes in cortical excitability. Physical Activity (PA): 20 minutes of cycling on an ergonomic cross-trainer
OG001	Sham tDCS+PA	sham tDCS: During a sham session, the device is programmed to ramp up to the desired intensity (target 2.5 mA) and ramp down for the initial 60 seconds, with no current delivery during the session, and then again at the end of the session. These brief periods of stimulation serve to mimic the effects of a true stimulation session. Physical Activity (PA): 20 minutes of cycling on an ergonomic cross-trainer

Units	Counts

Secondary

Change 21-item Modified Fatigue Impact Scale Score

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.

Posted

Mean

Standard Deviation

score on a scale

Baseline, Follow-Up Visit (3 days after final treatment session, up to 4 weeks)

ID	Title	Description
OG000	Active tDCS+PA	active tDCS: tDCS is a therapeutic treatment that utilizes low amplitude direct currents (<4 mA) to induce changes in cortical excitability. Physical Activity (PA): 20 minutes of cycling on an ergonomic cross-trainer
OG001	Sham tDCS+PA	sham tDCS: During a sham session, the device is programmed to ramp up to the desired intensity (target 2.5 mA) and ramp down for the initial 60 seconds, with no current delivery during the session, and then again at the end of the session. These brief periods of stimulation serve to mimic the effects of a true stimulation session. Physical Activity (PA): 20 minutes of cycling on an ergonomic cross-trainer

Units	Counts
Participants

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Active tDCS+PA	active tDCS: tDCS is a therapeutic treatment that utilizes low amplitude direct currents (<4 mA) to induce changes in cortical excitability. Physical Activity (PA): 20 minutes of cycling on an ergonomic cross-trainer	0	13	0	13	12	13
EG001	Sham tDCS+PA	sham tDCS: During a sham session, the device is programmed to ramp up to the desired intensity (target 2.5 mA) and ramp down for the initial 60 seconds, with no current delivery during the session, and then again at the end of the session. These brief periods of stimulation serve to mimic the effects of a true stimulation session. Physical Activity (PA): 20 minutes of cycling on an ergonomic cross-trainer	0	9	0	9	9	9

Other Adverse Events

Term	Organ System	Assessment Type	Statistical Information
Tingling at the electrode site	General disorders	Systematic Assessment	EG00010 affected13 at risk EG0018 affected9 at risk
Itching at the electrode site	General disorders	Systematic Assessment	EG0009 affected13 at risk EG0016 affected9 at risk
Warmth Sensation at the electrode site	General disorders	Systematic Assessment	EG0005 affected13 at risk EG0014 affected9 at risk

Title	Organization	Phone	Extension	Email
Mathew Lustberg, MA	NYU Langone Health	929 445 5090		Matthew.Lustberg@nyulangone.org

First MCP Posted Date

ID	Term
D009103	Multiple Sclerosis

Ancestor Terms

ID	Term
D020278	Demyelinating Autoimmune Diseases, CNS
D020274	Autoimmune Diseases of the Nervous System
D009422	Nervous System Diseases
D003711	Demyelinating Diseases
D001327	Autoimmune Diseases
D007154	Immune System Diseases

ID	Term
D015444	Exercise

ID	Term
D009043	Motor Activity
D009068	Movement
D009142	Musculoskeletal Physiological Phenomena
D055687	Musculoskeletal and Neural Physiological Phenomena