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Tele-rehabilitation Using tDCS Combined With Exercise in People With Spinal Cord Injury

Primary Purpose

Spinal Cord Injury, Incomplete Spinal Cord Injury

Status
Recruiting
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
Transcranial direct current stimulation (Active)
Transcranial direct current stimulation (Sham)
Telerehabilitation exercise
Sponsored by
Mahidol University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spinal Cord Injury focused on measuring rehabilitation, home-based exercise, tDCS, SCI

Eligibility Criteria

18 Months - 70 Months (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Individuals with any level of SCI with age between 18-70 years. Onset of injury between 1-30 month. Must have electronic devices such as mobile phones or tablets or computers that can connect to the internet. Exclusion Criteria: Receiving other NIBS and alternative medicine e.g. TMS, acupuncture. Having unstable cardiopulmonary disease e.g. unstable angina, uncontrolled atrial or ventricular arrythmias. 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 (30) which are Having 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 epilepsy.

Sites / Locations

  • Mahidol UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Active tDCS and telerehabilitation exercise program

Sham tDCS and Telerehabilitation exercise

Arm Description

Participants will receive active tDCS with an intensity 2 mA for 20 minutes and a telerehabilitation exercise program for 50 minutes. The program will be implemented over 12 sessions, occurring three times a week for four weeks).

Participants will receive sham tDCS for 20 minutes. The program will be implemented over 12 sessions, occurring three times a week for four weeks.

Outcomes

Primary Outcome Measures

Change from baseline: ASIA impairment scale
The American spinal injury association is a universal classification tool for spinal cord injuries based on a standardized sensory and motor assessment, to determine the Sensory Level and Motor Level for each side of the body (Right and Left), the single Neurological Level of Injury (NLI) and whether the injury is Complete or Incomplete. For the Key Sensory point that related to the dermatomes C2 - S5. They are tested bilaterally using Light Touch (LT) (tested by cotton tip) and Pin-Prick (PP) [sharp-dull discrimination]. For motor examination, key motor function of the myotomes C5 - T1 and L2 - S1 are tested bilaterally.

Secondary Outcome Measures

Change from baseline: the soleus H-reflex
The soleus H-reflex is a monosynaptic response that is reliably elicited in the lower limb by stimulating the posterior tibial nerve (PTN) in the popliteal fossa. The H-reflex is evoked in the soleus muscle by percutaneous PTN stimulation with a 1 ms duration stimulus delivered at 0.33 Hz. Surface electrodes are used to record the H-reflex and motor (M) response from the soleus muscle. The M response represents direct motor activation, while the H-reflex appears later. The latency of the M response is 5-10 msec, while the H-reflex latency is 25-35 msec. Expressing the H-reflex as a percentage of the maximum M response (Mmax) allows for comparisons between individuals. The H-reflex response (Hmax) and Mmax will be recorded to calculate the H-reflex latency and H/M amplitude ratio.
Change from baseline: Modified Ashworth scale
A clinical tool used to measure the increase of muscle tone.
Change from baseline: Deep tendon reflex score
A clinical tool used to measure muscle stretch reflex response
Change from baseline: Upper limb muscle strength
This test will be used for assessing the improvement of upper limb muscle strength including shoulder flexor, shoulder abductor, shoulder extensor shoulder adductor, elbow flexor, wrist extensor, elbow extensor, and wrist flexor on both sides. The muscle strength will be assessed by using hand-held dynamometer (Lafayette Electronic Hand-held Dynamometer). This test had good reliability for testing in SCI. The participants will be asked to exert force against the dynamometer over a period second while the assessor will hold the dynamometer steady against their effort. The peak force (Newton) will be chosen for an outcome.
Change from baseline: Spinal cord independence measure III (SCIM III)
The Spinal Cord Independence Measure (SCIM) is a scale for the assessment of achievements of daily function of patients with spinal cord lesions (SCLs). The third version (SCIM III) contains 19 tasks organized in 3 subscales: self-care, respiration and sphincter management, and mobility. This study will assess only 2 subscales of self-care and mobility.
Change from baseline: Transfer assessment instrument (TAI)
The TAI evaluates wheelchair preparation, body setup, and flight phases of the transfer. It has good face, content, and construct validity for community-dwelling mobility device users. Each of the items in the TAI is scored "yes" (1 point), "no" (0 points), or "not applicable" (item not included in scoring), resulting in a minimum score of 0 and a maximum score of 10.
Change from baseline: Quality of life measure
The participants' QOL will also be evaluated by using the WHOQOL-BREF-Thai questionnaire that can be assessed by self-report. In situations that the participants cannot read, the assessor will read for them, and they will have to choose the answer by themselves. The WHOQOL-BREF questionnaire has two types of questions: perceived objective and self-report subjective, and it includes four components of well-being: physical, psychological, social, and environmental. Each item is scored from 1-5. This Thai version has a good internal consistency with Cronbach's alpha 0.84. The higher score indicates better QOL.

Full Information

First Posted
June 25, 2023
Last Updated
October 9, 2023
Sponsor
Mahidol University
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1. Study Identification

Unique Protocol Identification Number
NCT06079138
Brief Title
Tele-rehabilitation Using tDCS Combined With Exercise in People With Spinal Cord Injury
Official Title
Tele-rehabilitation Using Transcranial Direct Current Stimulation Combined With Exercise in People With Spinal Cord Injury
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 30, 2023 (Anticipated)
Primary Completion Date
March 30, 2024 (Anticipated)
Study Completion Date
April 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mahidol University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study aims to explore the effect of trans cranial direct current stimulation (tDCS) combined with self-exercise at home for 1 month training (3 sessions/week, for 4 weeks). The outcome assessment including motor function, functional activity, spasticity through neurological assessment (H reflex latency and H/M amplitude ratio) and quality of life will be assessed before, after the intervention and at 1- month follow-up. Participant will communicate with physical therapist via video online platform for every sessions (12 sessions).
Detailed Description
Spinal cord injury (SCI) can cause paralysis and functional disability, resulting in changes in strength and sensation. Rehabilitation is important for regaining independence, but short hospital stays and limited access to specialized clinics pose challenges. Telerehabilitation offers a solution by providing remote rehabilitation services. Physical exercise and functional training are important for improving functional activity and endurance after SCI. Telerehabilitation has shown significant improvements in functional activity. However, the most effective gains occur within the first year after the injury, and rehabilitation training alone may not achieve full recovery. Impairments below the injury level can lead to changes in brain organization. Combining training with a top-down approach may promote motor recovery after SCI. Transcranial direct current stimulation (tDCS) is a non-invasive brain stimulation technique used in neurorehabilitation. It can modulate neural activity in the primary motor cortex at both cortical and spinal levels and induce synaptic plasticity. Studies have shown that adjusting the intensity or duration of tDCS can enhance its effectiveness, with anodal stimulation increasing cortical excitability and cathodal stimulation decreasing it. Home-based tDCS is a safe, accessible, and convenient alternative to hospital-based tDCS. Previous research has suggested a positive trend for combining anodal tDCS with rehabilitation training in individuals with incomplete spinal cord injury. Strong arm endurance is crucial for individuals with complete SCI who require independent transfers and wheelchair use. Studies in healthy adults have demonstrated that tDCS combined with exercise can improve upper arm endurance. However, there is currently no research on the effects of tDCS combined with rehabilitation in improving functional skills for individuals with complete SCI, especially when applied through home-based tDCS with telerehabilitation. In the early stages of spinal shock following a severe spinal cord injury (SCI), the H-reflex, a reflex measure of spinal cord excitability, is typically absent or significantly reduced below the injury site. The degree and duration of this reflex suppression indicate the severity of the injury. This loss of reflex activity is thought to result from decreased excitability of motoneurons due to the sudden loss of input from the brain. However, the H-reflex gradually starts to recover after the initial spinal shock phase. In patients with chronic complete spinal cord lesions, an increased H-reflex amplitude in the soleus muscle suggests heightened central synaptic excitability, which may contribute to the development of hyperreflexia after SCI. Recent research has shown that anodal tDCS can decrease the H/M ratio (the ratio of H-reflex to M-response) and H-reflex latency, leading to improved spasticity in patients with neurological conditions. This study aims to investigate the impact of combining tDCS with self-exercise at home over a one-month training period. The training will involve three sessions per week for four weeks. The assessment will include measures of motor function, functional activity, spasticity (evaluated through neurological assessment of H-reflex latency and H/M amplitude ratio), and quality of life. The participants will interact with a physical therapist through a video online platform for each of the 12 sessions. Assessments will be conducted before and after the intervention, as well as at a one-month follow-up.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injury, Incomplete Spinal Cord Injury
Keywords
rehabilitation, home-based exercise, tDCS, SCI

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Model Description
The participants will be divided into 2 groups. Intervention group will receive active tDCS with intensity 2 mA and control group will receive sham tDCS.
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
48 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Active tDCS and telerehabilitation exercise program
Arm Type
Experimental
Arm Description
Participants will receive active tDCS with an intensity 2 mA for 20 minutes and a telerehabilitation exercise program for 50 minutes. The program will be implemented over 12 sessions, occurring three times a week for four weeks).
Arm Title
Sham tDCS and Telerehabilitation exercise
Arm Type
Sham Comparator
Arm Description
Participants will receive sham tDCS for 20 minutes. The program will be implemented over 12 sessions, occurring three times a week for four weeks.
Intervention Type
Device
Intervention Name(s)
Transcranial direct current stimulation (Active)
Other Intervention Name(s)
tDCS (Active)
Intervention Description
Participants will sit comfortably during the stimulation, and the scalp will be cleaned with alcohol beforehand. The Ybrain MINDD STIM current stimulator will be used with saline-soaked sponge-pad electrodes (35 cm2 in size). Electrode placement will follow the 10-20 EEG system, with the active (anodal) electrode (A) positioned at the vertex (Cz) on the more affected side and the reference (cathodal) electrode (C) placed over the supraorbital region on the less affected side. The electrodes will be attached to a cap before application. In the experimental group, participants will receive real tDCS at 2.0 mA for 20 minutes, with a 30-second ramp-up and ramp-down period.
Intervention Type
Device
Intervention Name(s)
Transcranial direct current stimulation (Sham)
Other Intervention Name(s)
tDCS (Sham)
Intervention Description
Participants will sit comfortably during the stimulation, and the scalp will be cleaned with alcohol beforehand. The Ybrain MINDD STIM current stimulator will be used with saline-soaked sponge-pad electrodes (35 cm2 in size). Electrode placement will follow the 10-20 EEG system, with the active (anodal) electrode (A) positioned at the vertex (Cz) on the more affected side and the reference (cathodal) electrode (C) placed over the supraorbital region on the less affected side. The electrodes will be attached to a cap before application. The sham group will receive sham tDCS, where the current will only be delivered for the first 30 seconds and automatically stopped, while the electrodes remain in place for 20 minutes.
Intervention Type
Other
Intervention Name(s)
Telerehabilitation exercise
Intervention Description
Telerehabilitation exercise will be provided via tele-conference meeting program. The program will consist of 3 parts. First part, there will be a limb exercise program for 20 minutes to prepare the joint range of motion and muscles. Second part, participants will receive functional balance training for 15 minutes to promote their postural balance during changing positions and static positions. Each exercise will perform 10 repetitions for each set and perform 3 sets. After 2-week of intervention, the set will be progressed to 4 sets. Final part, participants will receive 20 minutes of functional training of wheelchair/bed transferring exercise. Each wheelchair and bed transfer exercise will perform 10 repetitions for each completely transfer and perform 3 sets. After 2-week of intervention, the set will be progressed to 4 sets. After finishing all the programs, they will be asked to cool down by doing breathing exercises with torso stretching for 5 minutes.
Primary Outcome Measure Information:
Title
Change from baseline: ASIA impairment scale
Description
The American spinal injury association is a universal classification tool for spinal cord injuries based on a standardized sensory and motor assessment, to determine the Sensory Level and Motor Level for each side of the body (Right and Left), the single Neurological Level of Injury (NLI) and whether the injury is Complete or Incomplete. For the Key Sensory point that related to the dermatomes C2 - S5. They are tested bilaterally using Light Touch (LT) (tested by cotton tip) and Pin-Prick (PP) [sharp-dull discrimination]. For motor examination, key motor function of the myotomes C5 - T1 and L2 - S1 are tested bilaterally.
Time Frame
Baseline, post-intervention day 30, and 1-month after post-intervention
Secondary Outcome Measure Information:
Title
Change from baseline: the soleus H-reflex
Description
The soleus H-reflex is a monosynaptic response that is reliably elicited in the lower limb by stimulating the posterior tibial nerve (PTN) in the popliteal fossa. The H-reflex is evoked in the soleus muscle by percutaneous PTN stimulation with a 1 ms duration stimulus delivered at 0.33 Hz. Surface electrodes are used to record the H-reflex and motor (M) response from the soleus muscle. The M response represents direct motor activation, while the H-reflex appears later. The latency of the M response is 5-10 msec, while the H-reflex latency is 25-35 msec. Expressing the H-reflex as a percentage of the maximum M response (Mmax) allows for comparisons between individuals. The H-reflex response (Hmax) and Mmax will be recorded to calculate the H-reflex latency and H/M amplitude ratio.
Time Frame
Baseline, post-intervention day 30, and 1-month after post-intervention
Title
Change from baseline: Modified Ashworth scale
Description
A clinical tool used to measure the increase of muscle tone.
Time Frame
Baseline, post-intervention day 30, and 1-month after post-intervention
Title
Change from baseline: Deep tendon reflex score
Description
A clinical tool used to measure muscle stretch reflex response
Time Frame
Baseline, post-intervention day 30, and 1-month after post-intervention
Title
Change from baseline: Upper limb muscle strength
Description
This test will be used for assessing the improvement of upper limb muscle strength including shoulder flexor, shoulder abductor, shoulder extensor shoulder adductor, elbow flexor, wrist extensor, elbow extensor, and wrist flexor on both sides. The muscle strength will be assessed by using hand-held dynamometer (Lafayette Electronic Hand-held Dynamometer). This test had good reliability for testing in SCI. The participants will be asked to exert force against the dynamometer over a period second while the assessor will hold the dynamometer steady against their effort. The peak force (Newton) will be chosen for an outcome.
Time Frame
Baseline, post-intervention day 30, 1-month after post-intervention
Title
Change from baseline: Spinal cord independence measure III (SCIM III)
Description
The Spinal Cord Independence Measure (SCIM) is a scale for the assessment of achievements of daily function of patients with spinal cord lesions (SCLs). The third version (SCIM III) contains 19 tasks organized in 3 subscales: self-care, respiration and sphincter management, and mobility. This study will assess only 2 subscales of self-care and mobility.
Time Frame
Baseline, post-intervention day 30, 1-month after post-intervention
Title
Change from baseline: Transfer assessment instrument (TAI)
Description
The TAI evaluates wheelchair preparation, body setup, and flight phases of the transfer. It has good face, content, and construct validity for community-dwelling mobility device users. Each of the items in the TAI is scored "yes" (1 point), "no" (0 points), or "not applicable" (item not included in scoring), resulting in a minimum score of 0 and a maximum score of 10.
Time Frame
Baseline, post-intervention day 30, 1-month after post-intervention
Title
Change from baseline: Quality of life measure
Description
The participants' QOL will also be evaluated by using the WHOQOL-BREF-Thai questionnaire that can be assessed by self-report. In situations that the participants cannot read, the assessor will read for them, and they will have to choose the answer by themselves. The WHOQOL-BREF questionnaire has two types of questions: perceived objective and self-report subjective, and it includes four components of well-being: physical, psychological, social, and environmental. Each item is scored from 1-5. This Thai version has a good internal consistency with Cronbach's alpha 0.84. The higher score indicates better QOL.
Time Frame
Baseline, post-intervention day 30, 1-month after intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Months
Maximum Age & Unit of Time
70 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Individuals with any level of SCI with age between 18-70 years. Onset of injury between 1-30 month. Must have electronic devices such as mobile phones or tablets or computers that can connect to the internet. Exclusion Criteria: Receiving other NIBS and alternative medicine e.g. TMS, acupuncture. Having unstable cardiopulmonary disease e.g. unstable angina, uncontrolled atrial or ventricular arrythmias. 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 (30) which are Having 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 epilepsy.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wanalee Klomjai, PhD
Phone
+6624415450
Email
wanalee.klo@mahidol.edu
Facility Information:
Facility Name
Mahidol University
City
Salaya
State/Province
Nakhon Pathom
ZIP/Postal Code
73170
Country
Thailand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wanalee Klomjai, PhD
Phone
+662441550
Ext
20216
Email
wanalee.klo@mahidol.edu
First Name & Middle Initial & Last Name & Degree
Thanwarat Chantanachai, PhD
First Name & Middle Initial & Last Name & Degree
Wanalee Klomjai, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Tele-rehabilitation Using tDCS Combined With Exercise in People With Spinal Cord Injury

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