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

NCT02920333 | Terminated DMC

• 1 other identifier: NIBS2014/00359
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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. 1.When combined with conventional gait training, NIBS could improve the walking ability of stroke survivors.
2. 2.NIBS will modulate cortex activity of the brain area representing the lower limbs.
3. 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.

Conditions

Stroke

Keywords

stroke; transcraniel direct current stimulation; repetitive transcraniel magnetic stimulation; rehabilitation; lower extremities

Outcome Measures

Primary Outcomes (1)

• changes of " gait parameters" from baseline to post-intervention and 4 weeks after intervention

  Gait analysis will be performed using the Tekscan walkway system. Subjects will be required to walk on a mat at their comfort speed. Gait parameters including step and stride parameters, symmetry scores, velocity, and cadence temporal will be collected and recorded while the subject is walking along the walkway.

  before intervention, immediately after intervention, 4 weeks after intervention

Secondary Outcomes (7)

• changes of "cortical excitability measured by TMS" from baseline to post-intervention and 4 weeks after intervention

  before intervention, immediately after intervention, 4 weeks after intervention

• changes of " Blood BDNF level" from baseline to post-intervention and 4 weeks after intervention

  before intervention, immediately after intervention, 4 weeks after intervention

• changes of " cortical excitability measured by fMRI" from baseline to post-intervention and 4 weeks after intervention

  before intervention, immediately after intervention, 4 weeks after intervention

• changes of " Psychological and cognitive properties" from baseline to post-intervention and 4 weeks after intervention

  before intervention, immediately after intervention, 4 weeks after intervention

• changes of walking speed measured by "10 meter walk test" from baseline to post-intervention and 4 weeks after intervention

  before intervention, immediately after intervention, 4 weeks after intervention

Study Arms (3)

tDCS+ rehab training

EXPERIMENTAL

tDCS will be applied 10 days, followed by conventional rehab training. Anodal stimulation will be conducted at the intensity of 2 mA and last for 20 minutes over the affected primary motor cortex of cortical representation of the tibialis anterior muscle.

Procedure: conventional rehab training; Device: tDCS

rTMS+ rehab training

EXPERIMENTAL

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.

Procedure: conventional rehab training; Device: rTMS

sham tDCS+ rehab training

SHAM COMPARATOR

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.

Procedure: conventional rehab training; Device: sham tDCS

Interventions

conventional rehab training PROCEDURE

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

rTMS+ rehab training; sham tDCS+ rehab training; tDCS+ rehab training

tDCS DEVICE

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.

tDCS+ rehab training

rTMS DEVICE

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.

rTMS+ rehab training

sham tDCS DEVICE

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.

sham tDCS+ rehab training

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• For subjects receiving intervention:
• Male or female aged 21-80 years;
• First ever haemorrhagic or ischaemic subcortical stroke of 3-6 months prior to study enrolment;
• Functional Ambulatory Category 3 (requires not more than minimal assistance for walking);
• Be able to provide informed consent.
• For healthy subjects:
• Male or female aged 21-80 years;
• Physically healthy;
• Be able to provide informed consent.

You may not qualify if:

• For subjects receiving intervention:
• Severe claustrophobia;
• pregnancy;
• cardiac pacemakers;
• orthodontics (braces);
• metal implant;
• presence of other non MRI-compatible ferromagnetic implants;
• history of epilepsy;
• sensorimotor disturbance due to other causes other than stroke;
• severe pain in the lower limbs affecting gait;
• uncontrolled medical conditions including hypertension, diabetes mellitus and unstable angina;
• major depression and a history of psychotic disorders (Subject with BDI score more than 30 will be excluded).
• For healthy subjects:
• Cardiovascular diseases;
• Diabetes mellitus;

Sponsors & Collaborators

• National University Hospital, Singapore: lead
• National University of Singapore: collaborator

Study Sites (1)

National University Hospital

Singapore, 119228, Singapore

Location

MeSH Terms

Conditions

Stroke

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

• Effie Chew, MD

  National University Hospital, Singapore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2014
• First Posted: September 30, 2016
• Study Start: February 1, 2016
• Primary Completion: July 1, 2020
• Study Completion: July 1, 2020
• Last Updated: April 22, 2022

Record last verified: 2022-04

Locations

SG (1)