Tele-rehabilitation Using TDCS Combined with Exercise in People with Spinal Cord Injury

NCT06079138 | Completed

• 1 other identifier: MU-CIRB 2023/119.0504
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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).

Conditions

Spinal Cord Injury; Incomplete Spinal Cord Injury

Keywords

rehabilitation; home-based exercise; tDCS; SCI

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline, post-intervention day 30, and 1-month after post-intervention

Secondary Outcomes (6)

• Change from baseline: the soleus H-reflex

  Baseline, post-intervention day 30, and 1-month after post-intervention

• Change from baseline: Modified Ashworth scale

  Baseline, post-intervention day 30, and 1-month after post-intervention

• Change from baseline: Upper limb muscle strength

  Baseline, post-intervention day 30, 1-month after post-intervention

• Change from baseline: Spinal cord independence measure III (SCIM III)

  Baseline, post-intervention day 30, 1-month after post-intervention

• Change from baseline: Transfer assessment instrument (TAI)

  Baseline, post-intervention day 30, 1-month after post-intervention

Study Arms (2)

Active tDCS and telerehabilitation exercise program

EXPERIMENTAL

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).

Device: Transcranial direct current stimulation (Active); Other: Telerehabilitation exercise

Sham tDCS and Telerehabilitation exercise

SHAM COMPARATOR

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

Device: Transcranial direct current stimulation (Sham); Other: Telerehabilitation exercise

Interventions

Transcranial direct current stimulation (Active) DEVICE

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.

Also known as: tDCS (Active)

Active tDCS and telerehabilitation exercise program

Transcranial direct current stimulation (Sham) DEVICE

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.

Also known as: tDCS (Sham)

Sham tDCS and Telerehabilitation exercise

Telerehabilitation exercise OTHER

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.

Active tDCS and telerehabilitation exercise program; Sham tDCS and Telerehabilitation exercise

Eligibility Criteria

• Age: 18 Months - 70 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mahidol University: lead

Study Sites (1)

Mahidol University

Salaya, Changwat Nakhon Pathom, 73170, Thailand

Location

MeSH Terms

Conditions

Spinal Cord Injuries

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

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

Model Details: 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.

Study Record Dates

• First Submitted: June 25, 2023
• First Posted: October 12, 2023
• Study Start: October 30, 2023
• Primary Completion: March 30, 2024
• Study Completion: August 22, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)