NCT04910412

Brief Summary

This study aim to investigate the effects of anodal transcranial direct current stimulation combined with gait training for 5 consecutive session on gait performance, balance, sit to stand performance and quality of life in persons with incomplete SCI at post intervention, 1-month follow-up and 2-month follow up

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 25, 2021

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

May 27, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 2, 2021

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2022

Completed
Last Updated

June 22, 2022

Status Verified

June 1, 2022

Enrollment Period

11 months

First QC Date

May 27, 2021

Last Update Submit

June 19, 2022

Conditions

Incomplete Spinal Cord Injury

Keywords

Transcranial direct current stimulationIncomplete spinal cord injuryLower limb performance

Outcome Measures

Primary Outcomes (3)

  • Change from baseline in gait efficacy assessed by walking speed(m/s) at 5 days

    10 meter walk test will be used for measuring walking speed in 2 pace which are 1) comfortable pace 2) fastest safe pace by ask the participants to walk along 14-meter walkway and the assessor will record the time at the middle 10 meters and calculate into speed of walking in m/s. Increasing walking speed indicates better walking performance.

    Baseline and 5 days

  • Change from baseline in gait efficacy assessed by walking speed(m/s) at 1 month

    10 meter walk test will be used for measuring walking speed in 2 pace which are 1) comfortable pace 2) fastest safe pace by ask the participants to walk along 14-meter walkway and the assessor will record the time at the middle 10 meters and calculate into speed of walking in m/s. Increasing walking speed indicates better walking performance.

    Baseline and 1 month

  • Change from baseline in gait efficacy assessed by walking speed (m/s) at 2 months

    10 meter walk test will be used for measuring walking speed in 2 pace which are 1) comfortable pace 2) fastest safe pace by ask the participants to walk along 14-meter walkway and the assessor will record the time at the middle 10 meters and calculate into speed of walking in m/s. Increasing walking speed indicates better walking performance.

    Baseline and 2 months

Secondary Outcomes (14)

  • Change from baseline in gait efficacy assessed by stride parameter (m) at 5 days

    Baseline and 5 days

  • Change from baseline in gait efficacy assessed by stride parameter (m) at 1 month

    Baseline and 1 month

  • Change from baseline in gait efficacy assessed by stride parameter (m) at 2 months

    Baseline and 2 months

  • Change from baseline in gait efficacy assessed by cadence (step/min) at 5 days

    Baseline and 5 days

  • Change from baseline in gait efficacy assessed by cadence (step/min) at 1 month

    Baseline and 1 month

  • +9 more secondary outcomes

Study Arms (2)

Anodal tDCS with gait training

EXPERIMENTAL

Anodal tDCS will be applied over the primary motor cortex (M1) (anodal or active electrode on M1 area, cathodal or reference electrode on supraorbital area) for 20 mins with 2 mA intensity before 50-minute of gait training with external cue and feedback for 5 consecutive sessions

Device: transcranial direct current stimulation

Sham tDCS with gait training

ACTIVE COMPARATOR

Sham tDCS will be applied over the primary motor cortex for 20mins before 50-minute of gait training with external cue and feedback for 5 consecutive sessions

Device: transcranial direct current stimulation

Interventions

transcranial direct current stimulationDEVICE

Transcranial direct current stimulation will be use for the intervention. Anodal and sham tDCS will be applied in 2 mA through a pair of saline-soaked surface sponge electrode 35 cm square for 20 minute over the primary motor area for modulating the cortical excitability before apply the rehabilitation training

Anodal tDCS with gait trainingSham tDCS with gait training

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • American Spinal Injury Association (ASIA) impairment scale C or D
  • Age between 18-70 years
  • Onset of injury between 1-30 months
  • Ability to walk at least 15 meters with or without walking aid

You may not qualify if:

  • Using other orthoses except the ankle-foot orthosis (AFO)
  • Having musculoskeletal pain limiting their walking (pain score \> 5/ 10)
  • Modified Ashworth Scale (MAS) greater than 2
  • Having unstable cardiopulmonary disease
  • Having uncontrolled conditions e.g. uncontrolled hypertension, uncontrolled diabetes
  • Having a history of other neurological diseases e.g. stroke
  • Having contra-indication to use tDCS which are
  • The presence of intracranial metal implantation, cochlear implant, or cardiac pacemaker
  • Having an open wound or wound infection on the scalp
  • Having a history of brain surgery
  • Having a history of seizure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sirindhorn National Medical Rehabilitation Institute

Nonthaburi, 11000, Thailand

Location

Related Publications (1)

  • Klamruen P, Suttiwong J, Aneksan B, Muangngoen M, Denduang C, Klomjai W. Effects of Anodal Transcranial Direct Current Stimulation With Overground Gait Training on Lower Limb Performance in Individuals With Incomplete Spinal Cord Injury. Arch Phys Med Rehabil. 2024 May;105(5):857-867. doi: 10.1016/j.apmr.2023.09.025. Epub 2023 Nov 4.

    PMID: 37926224DERIVED

MeSH Terms

Interventions

Transcranial Direct Current Stimulation

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsConvulsive TherapyPsychiatric Somatic TherapiesBehavioral Disciplines and ActivitiesElectroshockPsychological Techniques

Study Officials

  • Wanalee Klomjai, PhD

    Mahidol University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 27, 2021

First Posted

June 2, 2021

Study Start

May 25, 2021

Primary Completion

April 30, 2022

Study Completion

May 31, 2022

Last Updated

June 22, 2022

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will not share

Locations

TH(1)