Upper Extremity ParesisDOSESNCT03148106
Hand Rehabilitation Study for Stroke Patients
A study testing Somatosensory Electrical Stimulation in people with Upper Extremity Paresis and Disability Physical, run by University of California, San Francisco at 1 site in United States.
Trial summary
The purpose of this study is to find out what are the best settings for applying electrical nerve stimulation over the skin for the short-term improvement of hand dysfunction after a stroke. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Upper Extremity Paresis, Disability Physical, Chronic Stroke
- What is being tested?
- Somatosensory Electrical Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Apr 2017to 2 Dec 2025
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-80 years, has residual hand motor dysfunction caused by a single ischemic and/or hemorrhagic stroke greater than 6 months prior to enrollment.
Who cannot join
- Pregnant; uncontrolled medical problems including but not limited to severe cardiovascular and cardiopulmonary disease; active cancer; significant hand joint deformity or other diagnosis with major effect on hand function besides stroke; severe alcohol or drug abuse within the past year; untreated or inadequately treated major depression; spasticity score >3 on the MAS; lack of finger range of motion of at least 10 degrees; severe aphasia or other communicative, behavioral or cognitive impairment that significantly interferes with the participant's ability to comply with the protocol or provide informed consent. In addition, patients will be excluded if they have a pacemaker.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San Francisco
San Francisco, California, 94158
About this study
Official title: Optimizing Peripheral Stimulation Parameters to Modulate the Sensorimotor Cortex for Post-stroke Motor Recovery.
The purpose of this study is to find out what are the best settings for applying electrical nerve stimulation over the skin for the short-term improvement of hand dysfunction after a stroke. The ultimate goal is to some day design an effective long-term training program to help someone recovery their ability to use their hands and function independently at home and in society. In order to know how to apply electrical nerve stimulation to produce a good long-term effect on hand dysfunction, the investigators first need to know how to make it work best in the short-term, and improve our understanding of for whom it works and how it works. The investigators will use a commercially available transcutaneous electrical nerve stimulation (TENS) unit to gently apply electrical nerve stimulation over the skin of the affected arm. This is a portable, safe and easy to use device designed for patients to operate in their homes.
- Being tested
- Somatosensory Electrical Stimulation
- Medical subject headings
- Paresis, Motor Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Somatosensory Electrical StimulationDevice
Also called transcutaneous electrical nerve stimulation
The investigators will put adhesive electrodes on the affected arm and connect it to a device that will deliver a gentle electrical stimulation to the hand and arm. The stimulation will last for different amounts of time, depending on the stimulation condition. This can be 30 minutes twice a day (1 hour apart), 1 hour continuously, 2 hours continuously, or 3 hours continuously. The stimulation conditions will also vary in stimulation strength. It is normal that some people may feel a tingling sensation, while others may feel nothing.
| Study group | Role | What they receive |
|---|---|---|
| Somatosensory Electrical Stimulation | Experimental | Not described Receives: Device: Somatosensory Electrical Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Finger Fractionation
Ability to fractionate movement can be assessed by asking the patient to move one segment in isolation and keep other, adjacent segments still.
Measured: Baseline and immediately post-stimulation
Secondary outcomes (2)
Change in Modified Ashworth Scale
standard instrument
Measured: Baseline and immediately post-stimulation
Change in Arm Research Action Test
standard instrument
Measured: Baseline and immediately post-stimulation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2017
- Study start4 Apr 2017
- Primary completion2 Dec 2025
- Study completion2 Dec 2025
Why it stopped: COVID19 Pandemic
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Upper Extremity ParesisStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Karunesh Ganguly, MD, PhD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03148106
- Sponsor's protocol ID
- 13-12346
- Other IDs
- R01MH111871
- Acronym
- DOSES
- Status last verified
- Aug 2026
- First submitted
- 8 Mar 2017
- Last updated
- 20 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Peripheral Stimulation Parameters to Modulate the Sensorimotor Cortex for Post-stroke Motor Recovery.
- ClinicalTrials.gov ID
- NCT03148106
- Acronym / sponsor ID
- DOSES / 13-12346
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: COVID19 Pandemic
- Enrolment
- 14 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 4 Apr 2017 (actual)
- Primary completion
- 2 Dec 2025 (actual)
- Study completion
- 2 Dec 2025 (actual)
- First posted
- 10 May 2017 (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.
The purpose of this study is to find out what are the best settings for applying electrical nerve stimulation over the skin for the short-term improvement of hand dysfunction after a stroke. The ultimate goal is to some day design an effective long-term training program to help someone recovery their ability to use their hands and function independently at home and in society. In order to know how to apply electrical nerve stimulation to produce a good long-term effect on hand dysfunction, the investigators first need to know how to make it work best in the short-term, and improve our understanding of for whom it works and how it works. The investigators will use a commercially available transcutaneous electrical nerve stimulation (TENS) unit to gently apply electrical nerve stimulation over the skin of the affected arm. This is a portable, safe and easy to use device designed for patients to operate in their homes.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Somatosensory Electrical Stimulation | Experimental | Device: Somatosensory Electrical Stimulation |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Age 18-80 years, has residual hand motor dysfunction caused by a single ischemic and/or hemorrhagic stroke greater than 6 months prior to enrollment.
Key exclusion criteria (1 listed)
- Pregnant; uncontrolled medical problems including but not limited to severe cardiovascular and cardiopulmonary disease; active cancer; significant hand joint deformity or other diagnosis with major effect on hand function besides stroke; severe alcohol or drug abuse within the past year; untreated or inadequately treated major depression; spasticity score >3 on the MAS; lack of finger range of motion of at least 10 degrees; severe aphasia or other communicative, behavioral or cognitive impairment that significantly interferes with the participant's ability to comply with the protocol or provide informed consent. In addition, patients will be excluded if they have a 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 |
|---|---|---|
| Somatosensory Electrical StimulationAlso: transcutaneous electrical nerve stimulationThe investigators will put adhesive electrodes on the affected arm and connect it to a device that will deliver a gentle electrical stimulation to the hand and arm. The stimulation will last for different amounts of time, depending on the stimulation condition. This can be 30 minutes twice a day (1 hour apart), 1 hour continuously, 2 hours continuously, or 3 hours continuously. The stimulation conditions will also vary in stimulation strength. It is normal that some people may feel a tingling sensation, while others may feel nothing. | Device | Somatosensory Electrical Stimulation |
Primary outcome
Change in Finger Fractionation
Time frame: Baseline and immediately post-stimulation
Ability to fractionate movement can be assessed by asking the patient to move one segment in isolation and keep other, adjacent segments still.
2 secondary outcomes
Change in Modified Ashworth Scale
Time frame: Baseline and immediately post-stimulation
Change in Arm Research Action Test
Time frame: Baseline and immediately post-stimulation
Results and safety
The study was stopped early (reason given: COVID19 Pandemic). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2026.
- Individual participant dataSharing planned: No
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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.
Karunesh Ganguly, MD, PhD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Somatosensory Electrical Stimulation in people with Upper Extremity Paresis and Disability Physical, run by University of California, San Francisco at 1 site in United States.
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 1 inclusion and 1 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: stopped early, as of the sponsor's last update on 20 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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. 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?
The study was stopped early (reason given: COVID19 Pandemic). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Finger Fractionation (time frame: Baseline and immediately post-stimulation). 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 20 Aug 2026.