StrokeTransGaitNCT05740228
Transcranial Direct Current Stimulation for Gait Recovery Following Stroke
A study testing Anodal tDCS - Direct Current (DC)-stimulator (Soterix Medical, New York, NY, USA) and Anodal High-Definition (HD) tDCS - Direct Current (DC)-stimulator (Soterix Medical, New York, NY, USA) in people with Stroke and Gait, Hemiplegic, run by School of Health Sciences Geneva at 2 sites in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Gait, Hemiplegic
- What is being tested?
- Anodal tDCS - Direct Current (DC)-stimulator (Soterix Medical, New York, NY, USA) and Anodal High-Definition (HD) tDCS - Direct Current (DC)-stimulator (Soterix Medical, New York, NY, USA)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 2 sitesSwitzerland
- Study dates
- 1 Mar 2023to 30 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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,
Show all 13Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
Switzerland2 sites, 2 recruiting
- Not yet recruiting
Nicolo
Geneva, 1227
Pierre Nicolo, PhD, 0792633543, nicolopierre@gmail.com
- Recruiting
Pierre Nicolo
Geneva
Pierre Nicolo, PhD, 0792633543, nicolopierre@gmail.com
About this study
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:
Read more
- 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.
Read the detailed description
This clinical study will be conducted in a sham-controlled, triple-blinded randomized controlled design. The patients will be recruited - by convenience sampling - from the outpatient population of University Hospitals of Geneva. Neurologists and the Medical Investigator (MI) will be contacted to recruit potential patients and a consent letter will be sent to them. The patients will be screened to determine whether a potential participant is eligible to be enrolled in the study or not. Only the MI will conduct the screening procedures, which include reviewing medical record and in-person interview. All screening activities will take 15-30 min., and they will be performed in a private screening room. Enrollment will occur after verifying the eligibility and obtaining the signed written consent form. Patients will be enrolled in the study only if they met all the inclusion criteria.
After enrollment, all patients will be scheduled to receive 10 visits over four consecutive weeks. Each patient will be seen initially (1st visit and 2nd visit) for about 150 min. to conduct all baseline measurements (T0), which will include clinical examinations (90 min.) using different standardized tests for lower limb function (with spatiotemporal gait recording), and to conduct the EEG evaluation (60 min.). The follow-up sessions (3rd visit to 8th visit) will last for around 75 min. (30 min. for the preparation and placement of electrodes + 45 min. for physical therapy). All patients will be scheduled to receive 6 tDCS stimulations combined with physical therapy over 2 weeks (3 sessions/week). The 9th visit and 10th visit will last for about 150 min. to carry out the measurement tests (with spatiotemporal gait recording) and to conduct the EEG session (T1). The final visit (i.e., 11th visit) will be scheduled to be 4 weeks (90 min.) after the 10th visit to evaluate the long-term effects using the same clinical measurement tests (with spatiotemporal gait recording) (T2).
All the participants, physical therapists and assessors will be blinded to the type of stimulation applied. An experienced physical therapist will take all the baseline measurements (T0), post-stimulation measurements immediately after the intervention (T1), and long-term effects 4 weeks after the end of the stimulation period (T2). Another experienced physical therapist (i.e., not involved in clinical evaluations) will carry out all tDCS sessions and will conduct physical therapy. The tDCS stimulator will be pre-programmed by a researcher not involved in the study, and both this physical therapist and the patients were not aware of the applied treatment. The EEG assessment will be performed by a co-investigator not involved in another part of the study. Randomization will be generated with an allocation sequence based on randomly selected block sizes of 3, 6 and 9 and provided with a computer random-number generator by a researcher not involved in the study. Patients will be stratified for age and stroke laterality at randomization. Therefore, all the patients will be randomly assigned to one of three groups at a rate of 1:1:1:
Group A (n=12): receive anodal tDCS over the affected primary motor cortex
Group B (n=12): receive anodal HD-tDCS over the affected primary motor cortex
Group C (n=12): receive sham stimulation (alternatively sham anodal tDCS or sham anodal HD-tDCS).
This study protocol has been approved by the research ethics committee in Geneva.
- Conditions
- Stroke, Gait, Hemiplegic
- Being tested
- Anodal tDCS - Direct Current (DC)-stimulator (Soterix Medical, New York, NY, USA), Anodal High-Definition (HD) tDCS - Direct Current (DC)-stimulator (Soterix Medical, New York, NY, USA), Sham stimulation - Direct Current (DC)-stimulator (Soterix Medical, New York, NY, USA)
- Keywords
- Stroke, Brain plasticity, Gait, Physical therapy, tDCS, HD-tDCS, Spatiotemporal parameters during walking
- Medical subject headings
- Stroke, Gait Disorders, Neurologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 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.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Device: Sham stimulation - Direct Current (DC)-stimulator (Soterix Medical, New York, NY, USA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from baseline (T0) to immediately after the treatment period (T1)
Secondary outcomes (16)
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.
Measured: Change from baseline (T0) to one month after the treatment period (T2)
The 10-Meter Walk Test
The 10-Meter Walk Test (10 MWT) assesses walking speed (in meters per second) over a short distance (assistive device permitted). It can be employed to determine functional mobility and gait capacity. The test is completed at the subject's self-selected velocity.
Scoring is done by completing three trials with 1-min rest between each trial and calculating the average of the three trials to obtain the velocity.
Continuous measure, lower values indicate better outcome.
Measured: Change from baseline (T0) to immediately after the treatment period (T1) and one month after the treatment period (T2)
Timed Up and Go test
The Timed Up and Go test (TUG) is a test used to assess mobility, balance, and walking in people with balance impairments. The subject must stand up from a chair (which should not be leant against a wall), walk a distance of 3 meters, turn around, walk back to the chair and sit down - all performed as quickly and as safely as possible (assistive device permitted). Time will be measured using a chronometer (in seconds).
Scoring is done by completing three trials with 1-min rest between each trial and calculating the average of the three trials to obtain the measure.
Continuous measure, lower values indicate better outcome.
Measured: 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
The complete Fugl-Meyer contains 155 items and each item is rated on a three-point ordinal scale, 2 points for the detail being performed completely, 1 point for the detail being partially completed, and 0 points for the detail not being performed. The maximum score for the motor performance is divided into 66 points for the upper extremity and 34 for the lower extremity. Only the lower extremity motor assessment component of the Fugl-Meyer (FMA-LE) will be used for this study, which consists of 17 items.
Scoring is done by completing one trial.
Scale range 0-34 points, higher values indicate better outcome.
Measured: 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)
The Reintegration to Normal Living Index (RNLI) is a disability-related quality-of life-instrument (QOL) that will be used to measure mobility, self-care, daily activity, recreational activity, and family roles and has been validated on a population of community-dwelling individuals with chronic conditions. There are 11 items in the Reintegration to Normal Living Index. Each of these items is accompanied by a visual analog scale (VAS) anchored by phrases reflecting whether the statement describes the situation of the patient. It allows the patients to determine the extent to which the statement in question applies to their specific situation. Each VAS is scored out of 10 points: 1 = minimal reintegration, 10 = complete reintegration. The adjusted score = (total score)/110 * 100 will be calculated.
Scoring is done by completing one trial.
Scale range 0-100 points, higher scores indicate better outcome.
Measured: Change from baseline (T0) to immediately after the treatment period (T1) and one month after the treatment period (T2)
Functional connectivity from high-density EEG recordings
Resting state EEG functional connectivity (FC) analysis will be calculated. The absolute imaginary component of coherence between ipsilesional motor cortex and the rest of the brain will be subsequently calculated as index of functional connectivity. Separate values are obtained at each of seven frequency bands: delta (1-3 Hz), low theta (4-5 Hz), high theta (6-7 Hz), low alpha (8-10 Hz), high alpha (11-12 Hz), low beta (13-16 Hz), and high beta (17-20 Hz).
Continuous measure, higher values indicate better outcome.
Measured: Change from baseline (T0) to immediately after the treatment period (T1)
Walking performance - cadence
The unit is steps per minutes. Cadence is defined as the total number of steps you take in a minute while walking.
Gait cadence will be assessed during patients´comfort speed (the 6MWT) by instrumented gait analysis system (GaitUp, Lausanne, Switzerland).
Continuous measure, higher values indicate better outcome.
Measured: Change from baseline (T0) to immediately after the treatment period (T1) and one month after the treatment period (T2)
Walking performance - stride time
The unit is seconds. Stride time is defined as the time elapsed between the initial contacts of two consecutive footfalls of the same foot.
Stride time will be assessed during patients´comfort speed (the 6MWT) by instrumented gait analysis system (GaitUp, Lausanne, Switzerland).
Continuous measure, lower values indicate better outcome.
Measured: Change from baseline (T0) to immediately after the treatment period (T1) and one month after the treatment period (T2)
Walking performance - stride length
The unit is cm. Stride length is defined as the anterior-posterior distance between heels of two consecutive footprints of the same foot (left to left, right to right); two steps (e.g., a right step followed by a left step) comprise one stride or one gait cycle.
Stride length will be assessed during patients´comfort speed (the 6MWT) by instrumented gait analysis system (GaitUp, Lausanne, Switzerland).
Continuous measure, higher values indicate better outcome.
Measured: Change from baseline (T0) to immediately after the treatment period (T1) and one month after the treatment period (T2)
Walking performance - step length
The unit is cm. Step length is defined as the distance from heel contact of the first foot to heel contact of the subsequent contralateral foot.
Step length will be assessed during patients´comfort speed (the 6MWT) by instrumented gait analysis system (GaitUp, Lausanne, Switzerland).
Continuous measure, higher values indicate better outcome.
Measured: Change from baseline (T0) to immediately after the treatment period (T1) and one month after the treatment period (T2)
Walking performance - swing phase
The unit is percentage (%). Swing phase begins when the foot first leaves the ground and ends when the same foot touches the ground again.
Swing phase will be assessed during patients´comfort speed (the 6MWT) by instrumented gait analysis system (GaitUp, Lausanne, Switzerland).
Continuous measure, the swing phase occupies 40% of the total gait cycle (healthy individuals).
Measured: Change from baseline (T0) to immediately after the treatment period (T1) and one month after the treatment period (T2)
Walking performance - stance phase
The unit is percentage (%). Stance phase begins when the foot first touches the ground and ends when the same foot leaves the ground.
Stance phase will be assessed during patients´comfort speed (the 6MWT) by instrumented gait analysis system (GaitUp, Lausanne, Switzerland).
Continuous measure, the swing phase occupies 60% of the total gait cycle (healthy individuals).
Measured: Change from baseline (T0) to immediately after the treatment period (T1) and one month after the treatment period (T2)
Walking performance - symmetry ratio of stride length
The unit is ratio. V(larger value) / V(lesser value), V=step length(spatial) or step time(temporal)
Symmetry ratio of stride length will be assessed during patients´comfort speed (the 6MWT) by instrumented gait analysis system (GaitUp, Lausanne, Switzerland).
0-1 symmetry ratio comparing the stride length of the affected limb versus the unaffected limb during gait. If the unaffected limb performs equivalent to the affected limb, the ratio has a value of 1. The greater the disparity between limbs, the closer the ratio is to 0.
Measured: Change from baseline (T0) to immediately after the treatment period (T1) and one month after the treatment period (T2)
Walking performance - symmetry of percentage of time in swing phase of Gait
The unit is ratio. Symmetry of percentage of time in swing phase of gait will be assessed during patients´comfort speed (the 6MWT) by instrumented gait analysis system (GaitUp, Lausanne, Switzerland).
0-1 symmetry ratio compares the amount of time the unaffected leg is in swing phase of the gait cycle compared to the affected leg. The swing phase means the period of time during the gait cycle when one foot is not in contact with the ground. If the unaffected limb performs equivalent to the affected limb, the ratio has a value of 1. The greater the disparity between limbs, the closer the ratio is to 0.
Measured: Change from baseline (T0) to immediately after the treatment period (T1) and one month after the treatment period (T2)
Walking performance - time spent in double support phase of gait
The unit is percentage (%). Time spent in double support phase of gait is defined as the period in the gait cycle when both feet are in contact with the floor.
Time spent in double support phase of gait will be assessed during patients´comfort speed (the 6MWT) by instrumented gait analysis system (GaitUp, Lausanne, Switzerland).
Continuous measure, this makes up approximately 28-40% of the stance phase (healthy individuals).
Measured: Change from baseline (T0) to immediately after the treatment period (T1) and one month after the treatment period (T2)
Walking performance - gait cycle duration
The unit is seconds. Gait cycle duration (GCD) is defined as the time interval between two successive occurrences of one of the repetitive events of walking, herein the right heel strike).
GCD will be assessed during patients´comfort speed (the 6MWT) by instrumented gait analysis system (GaitUp, Lausanne, Switzerland).
Continuous measure, lower values indicate better outcome.
Measured: Change from baseline (T0) to immediately after the treatment period (T1) and one month after the treatment period (T2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2023
- Study start1 Mar 2023
- Primary completion30 Aug 2023 (estimated)
- Study completion30 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomised, triple-blind, placebo-controlled, parallel-group study
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- School of Health Sciences Geneva
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Geneva
- Responsible party
- Sponsor
- Investigators
- Pierre Nicolo, Principal investigator, HEdS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05740228
- Sponsor's protocol ID
- (PRD 10-2019-II)
- Acronym
- TransGait
- Status last verified
- Apr 2023
- First submitted
- 23 Jan 2023
- Last updated
- 18 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcranial Direct Current Stimulation for Gait Recovery Following Stroke
- ClinicalTrials.gov ID
- NCT05740228
- Acronym / sponsor ID
- TransGait / (PRD 10-2019-II)
- Conditions
- Stroke, Gait, Hemiplegic
- Keywords
- Stroke, Brain plasticity, Gait, Physical therapy, tDCS, HD-tDCS, Spatiotemporal parameters during walking
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- School of Health Sciences GenevaUniversity, hospital or other
- Collaborators
- University Hospital, Geneva
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 30 Aug 2023 (estimated)
- Study completion
- 30 Aug 2023 (estimated)
- First posted
- 22 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This clinical study will be conducted in a sham-controlled, triple-blinded randomized controlled design. The patients will be recruited - by convenience sampling - from the outpatient population of University Hospitals of Geneva. Neurologists and the Medical Investigator (MI) will be contacted to recruit potential patients and a consent letter will be sent to them. The patients will be screened to determine whether a potential participant is eligible to be enrolled in the study or not. Only the MI will conduct the screening procedures, which include reviewing medical record and in-person interview. All screening activities will take 15-30 min., and they will be performed in a private screening room. Enrollment will occur after verifying the eligibility and obtaining the signed written consent form. Patients will be enrolled in the study only if they met all the inclusion criteria.
After enrollment, all patients will be scheduled to receive 10 visits over four consecutive weeks. Each patient will be seen initially (1st visit and 2nd visit) for about 150 min. to conduct all baseline measurements (T0), which will include clinical examinations (90 min.) using different standardized tests for lower limb function (with spatiotemporal gait recording), and to conduct the EEG evaluation (60 min.). The follow-up sessions (3rd visit to 8th visit) will last for around 75 min. (30 min. for the preparation and placement of electrodes + 45 min. for physical therapy). All patients will be scheduled to receive 6 tDCS stimulations combined with physical therapy over 2 weeks (3 sessions/week). The 9th visit and 10th visit will last for about 150 min. to carry out the measurement tests (with spatiotemporal gait recording) and to conduct the EEG session (T1). The final visit (i.e., 11th visit) will be scheduled to be 4 weeks (90 min.) after the 10th visit to evaluate the long-term effects using the same clinical measurement tests (with spatiotemporal gait recording) (T2).
All the participants, physical therapists and assessors will be blinded to the type of stimulation applied. An experienced physical therapist will take all the baseline measurements (T0), post-stimulation measurements immediately after the intervention (T1), and long-term effects 4 weeks after the end of the stimulation period (T2). Another experienced physical therapist (i.e., not involved in clinical evaluations) will carry out all tDCS sessions and will conduct physical therapy. The tDCS stimulator will be pre-programmed by a researcher not involved in the study, and both this physical therapist and the patients were not aware of the applied treatment. The EEG assessment will be performed by a co-investigator not involved in another part of the study. Randomization will be generated with an allocation sequence based on randomly selected block sizes of 3, 6 and 9 and provided with a computer random-number generator by a researcher not involved in the study. Patients will be stratified for age and stroke laterality at randomization. Therefore, all the patients will be randomly assigned to one of three groups at a rate of 1:1:1:
Group A (n=12): receive anodal tDCS over the affected primary motor cortex
Group B (n=12): receive anodal HD-tDCS over the affected primary motor cortex
Group C (n=12): receive sham stimulation (alternatively sham anodal tDCS or sham anodal HD-tDCS).
This study protocol has been approved by the research ethics committee in Geneva.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
- Model description
- Randomised, triple-blind, placebo-controlled, parallel-group study
| Arm | Type | Receives |
|---|---|---|
| Anodal tDCS | Experimental | Device: Anodal tDCS - Direct Current (DC)-stimulator (Soterix Medical, New York, NY, USA)The anode is placed over the primary motor cortex of the stroke affected hemisphere, the cathode over the contralesional supraorbital front of the patient. |
| Anodal High-Definition (HD) tDCS | Experimental | Device: Anodal High-Definition (HD) tDCS - Direct Current (DC)-stimulator (Soterix Medical, New York, NY, USA)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. |
| Sham stimulation | Sham comparator | Device: Sham stimulation - Direct Current (DC)-stimulator (Soterix Medical, New York, NY, USA)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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,
Key exclusion criteria (13 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anodal tDCS - Direct Current (DC)-stimulator (Soterix Medical, New York, NY, USA)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. | Device | Anodal tDCS |
| Anodal High-Definition (HD) tDCS - Direct Current (DC)-stimulator (Soterix Medical, New York, NY, USA)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. | Device | Anodal High-Definition (HD) tDCS |
| Sham stimulation - Direct Current (DC)-stimulator (Soterix Medical, New York, NY, USA)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. | Device | Sham stimulation |
Primary outcome
The 6-Minute Walk Test
Time frame: Change from baseline (T0) to immediately after the treatment period (T1)
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.
16 secondary outcomes
The 6-Minute Walk Test
Time frame: Change from baseline (T0) to one month after the treatment period (T2)
The 10-Meter Walk Test
Time frame: Change from baseline (T0) to immediately after the treatment period (T1) and one month after the treatment period (T2)
Timed Up and Go test
Time frame: 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
Time frame: 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)
Time frame: Change from baseline (T0) to immediately after the treatment period (T1) and one month after the treatment period (T2)
Functional connectivity from high-density EEG recordings
Time frame: Change from baseline (T0) to immediately after the treatment period (T1)
Walking performance - cadence
Time frame: Change from baseline (T0) to immediately after the treatment period (T1) and one month after the treatment period (T2)
Walking performance - stride time
Time frame: Change from baseline (T0) to immediately after the treatment period (T1) and one month after the treatment period (T2)
Walking performance - stride length
Time frame: Change from baseline (T0) to immediately after the treatment period (T1) and one month after the treatment period (T2)
Walking performance - step length
Time frame: Change from baseline (T0) to immediately after the treatment period (T1) and one month after the treatment period (T2)
Walking performance - swing phase
Time frame: Change from baseline (T0) to immediately after the treatment period (T1) and one month after the treatment period (T2)
Walking performance - stance phase
Time frame: Change from baseline (T0) to immediately after the treatment period (T1) and one month after the treatment period (T2)
Walking performance - symmetry ratio of stride length
Time frame: Change from baseline (T0) to immediately after the treatment period (T1) and one month after the treatment period (T2)
Walking performance - symmetry of percentage of time in swing phase of Gait
Time frame: Change from baseline (T0) to immediately after the treatment period (T1) and one month after the treatment period (T2)
Walking performance - time spent in double support phase of gait
Time frame: Change from baseline (T0) to immediately after the treatment period (T1) and one month after the treatment period (T2)
Walking performance - gait cycle duration
Time frame: Change from baseline (T0) to immediately after the treatment period (T1) and one month after the treatment period (T2)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pierre Nicolo principal investigator
HEdS
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Anodal tDCS - Direct Current (DC)-stimulator (Soterix Medical, New York, NY, USA) and Anodal High-Definition (HD) tDCS - Direct Current (DC)-stimulator (Soterix Medical, New York, NY, USA) in people with Stroke and Gait, Hemiplegic, run by School of Health Sciences Geneva at 2 sites in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pierre Nicolo, PhD (0792633543, nicolopierre@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The 6-Minute Walk Test (time frame: Change from baseline (T0) to immediately after the treatment period (T1)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2023.