Transcranial Direct Current Stimulation for Gait Recovery Following Stroke

NCT05740228 | Unknown

• 1 other identifier: (PRD 10-2019-II)
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 2

Brief Summary

Background: Stroke is a leading cause of adult disability. The ability to walk is considered as the most important physical activity in daily life and strongly associated with quality of life in patients with stroke sequela. Conventional transcranial Direct Current Stimulation (tDCS) can induce mixed effects to improve gait impairment after stroke. The problem of limited focal specificity of tDCS may lead to an ineffective stimulation and in turn may be reduced the potential application of tDCS in clinical routine. High-definition transcranial Direct Current Stimulation (HD-tDCS) allows inducing, in a non-invasive way, a transient excitatory neuromodulation of a given cerebral region and to obtain a very focused cortical effect. However, the clinical and neurophysiological effects of HD-tDCS remain largely unknown for enhancing gait recovery in patients with stroke. The investigators hypothesize that anodal HD-tDCS will enhance neural interactions between motor networks and, thereby, improve motor processing and gait relearning. The investigators propose to carry out a study on chronic stroke patients involving anodal HD-tDCS of the affected primary motor cortex combined with a physical therapy. This study has three main objectives:

• To compare the effects of two techniques of tDCS (anodal tDCS, anodal HD-tDCS) on clinical recovery in patients with chronic stroke.
• To assess the effects of these brain stimulation techniques on brain reorganization with electroencephalography (EEG).
• To assess the effects of these brain stimulation techniques on spatiotemporal gait parameters during walking with wearable motion sensors. Methods: 36 patients with ischemic or hemorrhagic stroke will be randomly assigned to one of 3 groups: anodal tDCS, anodal HD-tDCS, or sham stimulation. Each group will receive the corresponding stimulation therapy 3 times per week for 2 weeks, simultaneously with physical therapy. Before (T0) and immediately after the treatment period (T1) and again one month later (T2), standardized assessments of sensorimotor function areas are obtained together with spatio-temporal analysis. Brain reorganization is assessed with EEG before and immediately after the treatment period. These recordings will be used to compare and investigate the clinical and physiological effects of each treatment modality.

Conditions

Stroke; Gait, Hemiplegic

Keywords

Stroke; Brain plasticity; Gait; Physical therapy; tDCS; HD-tDCS; Spatiotemporal parameters during walking

Outcome Measures

Primary Outcomes (1)

• The 6-Minute Walk Test

  The 6-Minute Walk Test (6MWT) is a patient self-paced walk test and measures the maximum distance (in meters) a subject cover during an indoor gait on a flat, hard surface in 6 minutes, using assistive devices, as necessary. The test is used as a sub-maximal test of aerobic capacity, endurance, and the level of functional capacity. Patients are allowed to stop and rest during the test. However, the timer does not stop. If the patient is unable to complete the test, the time is stopped at that moment. The missing time and the reason of the stop are recorded. This test will be administered while wearing a pulse oximeter to monitor heart rate and oxygen saturation, also integrated with Borg scale to assess dyspnea and endurance. The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity. Scoring is done by completing one trial. Continuous measure, higher values indicate better outcome.

  Change from baseline (T0) to immediately after the treatment period (T1)

Secondary Outcomes (16)

• The 6-Minute Walk Test

  Change from baseline (T0) to one month after the treatment period (T2)

• The 10-Meter Walk Test

  Change from baseline (T0) to immediately after the treatment period (T1) and one month after the treatment period (T2)

• Timed Up and Go test

  Change from baseline (T0) to immediately after the treatment period (T1) and one month after the treatment period (T2)

• Fugl-Meyer Assessment-Lower Extremity component

  Change from baseline (T0) to immediately after the treatment period (T1) and one month after the treatment period (T2)

• Reintegration to Normal Living Index Living (total score)

  Change from baseline (T0) to immediately after the treatment period (T1) and one month after the treatment period (T2)

Study Arms (3)

Anodal tDCS

EXPERIMENTAL

The anode is placed over the primary motor cortex of the stroke affected hemisphere, the cathode over the contralesional supraorbital front of the patient.

Device: Anodal tDCS - Direct Current (DC)-stimulator (Soterix Medical, New York, NY, USA)

Anodal High-Definition (HD) tDCS

EXPERIMENTAL

A single HD anode is placed over the primary motor cortex of the stroke affected hemisphere, 4 HD cathodes are placed over the affected hemisphere around the anode.

Device: Anodal High-Definition (HD) tDCS - Direct Current (DC)-stimulator (Soterix Medical, New York, NY, USA)

Sham stimulation

SHAM COMPARATOR

The electrodes are placed as in one of the active arms, but only a ramp up current is applied during 30 seconds and then switched off. This induces similar sensations for the patients, but no change in excitability.

Device: Sham stimulation - Direct Current (DC)-stimulator (Soterix Medical, New York, NY, USA)

Interventions

Anodal tDCS - Direct Current (DC)-stimulator (Soterix Medical, New York, NY, USA) DEVICE

A current of 2 milliamperes (mA) will be applied for 20 minutes, 3 times per week during 2 weeks, except for the sham tDCS arm. The motor rehabilitation program include (1) balance exercises , (2) sit-to-stand exercises, (3) step exercises, (4) leg exercises, (5) walking training (6) stair-stepping exercises.

Anodal tDCS

Anodal High-Definition (HD) tDCS - Direct Current (DC)-stimulator (Soterix Medical, New York, NY, USA) DEVICE

A current of 2 milliamperes (mA) will be applied for 20 minutes, 3 times per week during 2 weeks, except for the sham tDCS arm. The motor rehabilitation program include (1) balance exercises , (2) sit-to-stand exercises, (3) step exercises, (4) leg exercises, (5) walking training (6) stair-stepping exercises.

Anodal High-Definition (HD) tDCS

Sham stimulation - Direct Current (DC)-stimulator (Soterix Medical, New York, NY, USA) DEVICE

A current of 2 milliamperes (mA) will be applied for 20 minutes, 3 times per week during 2 weeks, except for the sham tDCS arm. The motor rehabilitation program include (1) balance exercises , (2) sit-to-stand exercises, (3) step exercises, (4) leg exercises, (5) walking training (6) stair-stepping exercises.

Sham stimulation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age ≥ 18 years,
• first haemorrhagic or ischemic stroke,
• time since stroke ≥ 12 months,
• unilateral lower limb hemiparesis with a Fugl-Meyer score (lower limb portion) less than 28 (out of a maximum score of 34),
• walking deficit with a Functional Ambulation Categories (FAC) score of more than 3,
• able to walk for 6 minutes with or without a walking aid, with or without a break, at a self-determined comfort pace,
• ability to concentrate and follow the study protocol,
• have given informed consent

You may not qualify if:

• second stroke during the protocol,
• botulinum toxin injection less than 3 months before the start of the protocol,
• impaired alertness with a Montreal Cognitive Assessment (MoCA) score below 23,
• metal object or implant near the stimulated area,
• pacemaker,
• vestibular disorders or vertigo,
• severe dystonia or spasticity with a Modified Ashworth Scale score of 3 or more,
• history of migraine,
• severe osteoarticular comorbidities of the lower limb,
• patients with one or more epileptic seizures,
• severe language impairment,
• other neurological or psychiatric disorder with severe impact on motor skills and activities of daily living, such as neurodegenerative disease, Parkinson's disease and others,
• Pregnant woman

Sponsors & Collaborators

• School of Health Sciences Geneva: lead
• University Hospital, Geneva: collaborator

Study Sites (2)

Nicolo

Geneva, 1227, Switzerland

NOT YET RECRUITING

Pierre Nicolo

Geneva, Switzerland

RECRUITING

MeSH Terms

Conditions

Stroke; Gait Disorders, Neurologic

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Pierre Nicolo

  HEdS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pierre Nicolo, PhD

CONTACT

0792633543; nicolopierre@gmail.com

Study Design

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

Model Details: Randomised, triple-blind, placebo-controlled, parallel-group study

Study Record Dates

• First Submitted: January 23, 2023
• First Posted: February 22, 2023
• Study Start: March 1, 2023
• Primary Completion: August 30, 2023
• Study Completion: August 30, 2023
• Last Updated: April 18, 2023

Record last verified: 2023-04

Locations

CH (2)