The Effect of Combined Transcranial Pulse Current Stimulation (tPCS) and Transcutaneous Electrical Nerve Stimulation (TENS) on Lower Limb Motor Function in Subacute to Chronic Stroke Patients With Hemiplegia (COMPENSATOR-Stroke)

NCT06999876 | Not Yet Recruiting DMC

• 1 other identifier: 2024-3371
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 2

Brief Summary

The goal of this study is to evaluate the effects of high frequency tPCS + TENS compared to Sham device stimulation + TENS (Control) in lower limb motor function recovery in stroke patients with hemiplegia or hemiparesis in the subacute stage.The main questions it aims to answer are: Primary objective - To evaluate the effects of high frequency tPCS + TENS compared to Sham device stimulation + TENS (Control) in lower limb motor function recovery, in stroke patients with hemiplegia or hemiparesis in the subacute stage Secondary Objectives -

• Be identified, recruited and have baseline assessments during screening period
• First undergo a mandatory 2-hour device training at Visit 2 to ensure device competence.
• Proceed with up to 7 days of habituation for device use and tolerability.
• Carry out daily intervention sessions of 30 minutes for 30 days at home or inpatient setting.
• Phone call follow-up (Telephone/ Video Call Interview) 2 weeks post intervention
• Clinic visit at day 30 post intervention with allowance of + 7 days for study assessments
• Clinic visit at day 90 post intervention with allowance of +/- 7 days for study assessments
• Update study coordinators via messaging platforms with regards to device issues, adverse events, any other reporting or questions

Conditions

Stroke Patients With Hemiplegia or Hemiparesis in the Subacute Stage

Keywords

Transcranial Pulsed Current Simulation; Transcutaneous Electrical Nerve Stimulation; Lower limb motor function recovery; Spasticity; Gait dysfunction; Standing balance; Ambulation; Stroke; Hemiplegia; Hemiparesis

Outcome Measures

Primary Outcomes (2)

• Lower Extremity Portion of Fugl-Meyer Assessment (LE-FMA)

  Effects of high frequency tPCS + TENS compared to Sham device stimulation + TENS (Control) in Lower Extremity Portion of Fugl-Meyer Assessment (LE-FMA). Mean change in LE-FMA from Visit 1 (Recruitment) to Visit 3 (Last day of intervention, Day 30 post intervention with allowance of + 7 days) and Visit 4 (Final follow-up, Day 90 post intervention with allowance of + 7 days).

  From enrollment to Day 90 post intervention (with allowance of + 7 days).

• Functional Independence Measure (FIM)

  Effects of high frequency tPCS + TENS compared to Sham device stimulation + TENS (Control) in functional independence measured using Functional Independence Measure (FIM) score, in stroke patients with hemiplegia or hemiparesis in the subacute stage. Mean change in FIM from Visit 1 (Recruitment) to Visit 3 (Last day of intervention, Day 30 post intervention with allowance of + 7 days) and Visit 4 (Final follow-up, Day 90 post intervention with allowance of + 7 days).

  From enrollment to Day 90 post intervention (with allowance of + 7 days).

Secondary Outcomes (9)

• Modified Ashworth Scale (MAS)

  From enrollment to Day 90 post intervention (with allowance of + 7 days).

• Modified Tardieu Scale (MTS)

  From enrollment to Day 90 post intervention (with allowance of + 7 days).

• Time Up and Go (TUG)

  From enrollment to Day 90 post intervention (with allowance of + 7 days).

• 10-meter Walk Test (10MWT)

  From enrollment to Day 90 post intervention (with allowance of + 7 days).

• 6-minute Walk Test

  From enrollment to Day 90 post intervention (with allowance of + 7 days).

Study Arms (2)

Intervention Arm

EXPERIMENTAL

Active tPCS + TENS treatment

Device: The AscenZ-VIII Stimulator (Investigational Medical Device)

Control arm

SHAM COMPARATOR

Sham tPCS + TENS treatment

Device: The AscenZ-VIII Stimulator (Investigational Medical Device)

Interventions

The AscenZ-VIII Stimulator (Investigational Medical Device) DEVICE

Sham tPCS current will be delivered through Channel 1, while active TENS treatment delivered through Channel 2, 3 and 4 of The AscenZ-VIII Stimulator via surface electrodes. The placement of electrodes will be exactly the same as the active tPCS montage.

Control arm

Eligibility Criteria

• Age: 21 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants aged 21 years old and below 80 years old with a clinically diagnosed first onset ischaemic stroke confirmed by imaging modalities such as computerised tomography (CT) or magnetic resonance imaging (MRI). Previous transient ischemic attack or clinically silent infarct detected by CT/MRI are not considered as previous stroke.
• Participants within the subacute stage of stroke (Within 14 days from stoke onset)
• Able to walk with or without assistance
• Able to understand instructions and give informed consent

You may not qualify if:

• History of craniotomy or placement of implant materials/ device in the body that may affect NIBS including, but not limited to, deep brain stimulator, cardiac implant, cochlear implant
• Intracranial haemorrhage in the cortical regions
• History of epilepsy or seizures
• History of major depression and a history of psychotic disorders
• Contraindications to tPCS/TENS e.g., pregnancy, presence of skin lesion at the intended treatment areas.
• Concurrent use of benzodiazepine pyschoactive class of drugs which may affect effects of tPCS
• Concurrent use of anti-seizure medications (ASMs) which may affect effects of tPCS
• Presence of significant cognitive impairment/ aphasia rendering patient unable to comply with the treatment protocol
• Presence of disabling comorbidities that compromises limb function such as orthopaedics or neurological pathologies other than stroke
• Previous treatments of the lower limb spasticity with botulinum toxin, or alcohol.
• Prior history of non-invasive brain stimulations

Sponsors & Collaborators

• National University Health System, Singapore: lead

Study Sites (2)

National University Hospital

Singapore, Singapore, 119228, Singapore

Location

Alexandra Hospital

Singapore, Singapore, 159964, Singapore

Location

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MeSH Terms

Conditions

Muscle Spasticity; Stroke; Hemiplegia; Paresis

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Paralysis

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr Jing Mingxue (Principal Investigator)

Model Details: Active tPCS + TENS treatment (Intervention arm) This group will receive active TENS treatment delivered through Channel 2, 3 and 4 of The AscenZ-VIII Stimulator via 6\*9cm Silica gel electrodes on top of the tPCS that is delivered through Channel 1. The placement of the electrodes will be on the part of the spinal segment innervating the lower limbs (L1-L5), the adductor muscles and the gastrocnemius muscles. Sham tPCS + TENS treatment (Control arm) Sham tPCS current will be delivered through Channel 1, while active TENS treatment delivered through Channel 2, 3 and 4 of The AscenZ-VIII Stimulator via surface electrodes. The placement of electrodes will be exactly the same as the active tPCS montage.

Study Record Dates

• First Submitted: May 13, 2025
• First Posted: May 31, 2025
• Study Start: May 31, 2025
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 31, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Time Frame: Beginning 6 months and ending 1 years after the publication of results
• Access Criteria: Analyses that qualify for data sharing: meta-analysis Data sharing agreement needs to be signed. Applicant can email the study's Principal Investigator to submit request.

Locations

SG (2)