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Shocking the hand back to life: which stimulator works best after stroke?

NCT ID NCT03574623

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

After a stroke, many people struggle to open their affected hand. This study tested two types of electrical stimulation—one that cycles on and off automatically, and another that is controlled by the good hand—plus standard occupational therapy. 132 stroke survivors took part to see which approach best improves hand dexterity and movement.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Electrical stimulator (device) and occupational therapy
What this could lead to
If successful, this could point toward a more effective way to help stroke survivors regain hand function and independence.
What could go wrong
This is a completed trial comparing existing therapies, so no major new breakthrough is expected. Results may show only modest differences between treatments.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

132 people

The number who actually took part.

Started

Feb 2019

Finished

Oct 2024

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

21 to 90 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 6 to 24 months since a first clinical cortical or subcortical, hemorrhagic or nonhemorrhagic stroke * unilateral upper limb hemiparesis with finger extensor strength of grade no more than 4 out of 5 on the Medical Research Council (MRC) scale * score of at least 1 and no more than 11 out of 14 on the hand section of the upper extremity Fugl-Meyer Assessment * adequate active movement of the shoulder and elbow to position the hand in the workspace for table-top task practice (necessary for the lab task practice sessions) * able to follow 3-stage commands * able to recall at least 2 of a list of 3 items after 30 minutes * skin intact on the hemiparetic arm * surface stimulation of the paretic finger and thumb extensors produces functional hand opening without pain (this will exclude those who have too much flexor spasticity) * able to hear and respond to cues from stimulator * not receiving occupational therapy (no concomitant OT) * full voluntary opening/closing of the contralateral (less affected) hand * demonstrates ability to follow instructions for operating the stimulator or have a caregiver who will assist them Exclusion Criteria: * co-existing neurologic diagnosis of peripheral nerve injury, Parkinson's disease, spinal cord injury, traumatic brain injury, or multiple sclerosis * uncontrolled seizure disorder * brainstem stroke * uncompensated hemineglect * severe shoulder or hand pain * insensate forearm or hand * history of potentially fatal cardiac arrhythmias with hemodynamic instability * implanted electronic systems (e.g. pacemaker) * botulinum toxin injections to any upper extremity muscle within 3 months of enrolling * pregnant women due to unknown risks of surface NMES during pregnancy * lack of functional passive range of motion of the wrist or fingers of affected side * diagnosis (apart from stroke) that substantially affects paretic arm and hand function * deficits in communication that interfere with reasonable study participation * lacking sufficient visual acuity to see the stimulator's display * concurrent enrollment in another investigational study

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Emory University and Atlanta VA

    Atlanta, Georgia, 30322, United States

  • Johns Hopkins University

    Baltimore, Maryland, 21205, United States

  • Kessler Foundation

    West Orange, New Jersey, 07052, United States

  • MetroHealth Rehabilitation Institute

    Cleveland, Ohio, 44109, United States

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