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Efficacy of the Non-invasive Brain Stimulation Techniques for Lower Limb Recovery in Stroke Patients

NCT02920333 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2022-04-22

No results posted yet for this study

Summary

This study is to compare the efficacy of two types of non-invasive brain stimulation (NIBS) in lower limb motor function recovery in stroke patients. The intervention will be tDCS (transcraniel direct current stimulation) or rTMS (repetitive transcraniel magnetic stimulation) plus conventional gait training for 10 days over 2 weeks.

The study hypothesizes that:

1. When combined with conventional gait training, NIBS could improve the walking ability of stroke survivors.
2. NIBS will modulate cortex activity of the brain area representing the lower limbs.
3. The effects of NIBS might be related to some genetic factors. 45 subjects will be randomly divided into 3 groups, receiving tDCS plus conventional gait training, or rTMS plus conventional gait training, or sham tDCS plus conventional gait training.

The outcome measures include clinical functional assessment, brain activity assessed by TMS measurement and MRI, genetic factor measurement. All these will be done at pre, immediate after intervention and 4 weeks after intervention.

Conditions

Interventions

PROCEDURE

conventional rehab training

Conventional rehab training will be conducted daily for 10 days, after NIBS intervention.

DEVICE

tDCS

tDCS will be applied 10 days, followed by conventional rehab training. Stimulation will be conducted at the intensity of 2 mA and last for 20 minutes. anode will be placed over the affected primary motor cortex (M1) of cortical representation of the tibialis anterior muscle (TA), while the cathode will be used as reference electrode and placed over the forehead of the unaffected side.

DEVICE

rTMS

rTMS will be applied 10 days, followed by conventional rehab training. Subjects will receive 10 Hz rTMS, and a total of 1200 pulses will be delivered for one treatment session.

DEVICE

sham tDCS

The same stimulation parameters as tDCS treatment will be employed for the sham stimulation. However, the current will be applied for 30 seconds only, to give subjects the sensation of the stimulation.

Sponsors & Collaborators

Principal Investigators

  • Effie Chew, MD · National University Hospital, Singapore

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-02-29
Primary Completion
2020-07-31
Completion
2020-07-31

Countries

  • Singapore

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02920333 on ClinicalTrials.gov