NCT06999876: COMPENSATOR

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)

Not yet recruiting NA Last updated 31 May 2025

What this trial tests

NA trial testing The AscenZ-VIII Stimulator (Investigational Medical Device) in Stroke Patients With Hemiplegia or Hemiparesis in the Subacute Stage in 90 participants. Not yet recruiting.

Timeline

31 May 2025

Primary endpoint
30 November 2026

31 December 2026

Quick facts

Lead sponsor	National University Health System, Singapore
Phase	NA
Status	Not yet recruiting
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	90
Start date	31 May 2025
Primary completion	30 November 2026
Estimated completion	31 December 2026
Sites	2 locations across Singapore

Drugs / interventions tested

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

Conditions studied

• Stroke Patients With Hemiplegia or Hemiparesis in the Subacute Stage — all drugs for Stroke Patients With Hemiplegia or Hemiparesis in the Subacute Stage →

Sponsor

National University Health System, Singapore

Who can join

Adults 21 to 79, any sex, with Stroke Patients With Hemiplegia or Hemiparesis in the Subacute Stage. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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 -

1. To evaluate the effects of high frequency tPCS + TENS in treatment of lower limb spasticity related to stroke.
2. To evaluate the effects of high frequency tPCS + TENS in gait function improvement post stroke, including walking speed, mobility, balance and walking endurance.
3. To evaluate the effects of high frequency tPCS on pain, mood and QOL.

Researchers will compare the effects of high frequency tPCS + TENS to a control group which involves intervention with Sham device stimulation + TENS.

Participants will:

* 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

Publications & conference data

No peer-reviewed publications indexed yet for this trial.