StrokeNCT03176550
Peripheral Stimulation Neural Response
A study testing Transcutaneous electrical nerve stimulation in people with Stroke, run by University of California, San Francisco.
Trial summary
Few patients recover full hand dexterity after an acquired brain injury such as stroke. Repetitive somatosensory electrical stimulation (SES) is a promising method to promote recovery of hand function. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Stroke
- What is being tested?
- Transcutaneous electrical nerve stimulation
- Type of treatment
- Medical device
- How many people
- 8 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2014to 30 Apr 2015
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- between 18-80 years old, with a history of an acquired brain injury resulting in residual hemiparesis or other motor deficits of the arm/hand equal to or more than 6 months prior to enrollment; and capacity to adhere with the schedule of interventions and evaluations determined in the protocol.
Who cannot join
- Subjects are excluded if they met any of the following criteria: currently pregnant; uncontrolled medical conditions; significant cognitive impairment on the Montreal Cognitive Assessment (MoCA ≤ 23); ≤ 10 degrees of active index finger range of motion; significant hand joint deformity; severe active alcohol or drug abuse; significant depression (PHQ-9 ≥15); baseline spasticity score (MAS) >3 for any joint tested (wrist and metacarpophalangeal joint flexion and extension); apraxia screen of Tulia (AST) <5; absent light touch, proprioception, pinprick and vibration sensation on the modified Nottingham Sensory Assessment; no upper limb strength against gravity; severe aphasia; or had an implanted pacemaker.
About this study
Official title: Effects of Somatosensory Electrical Simulation On Motor Function and Cortical Oscillations
Few patients recover full hand dexterity after an acquired brain injury such as stroke. Repetitive somatosensory electrical stimulation (SES) is a promising method to promote recovery of hand function. However, studies using SES have largely focused on gross motor function; it remains unclear if it can modulate distal hand functions such as finger individuation. The specific goal of this study was to monitor the effects of SES on individuation as well as on cortical oscillations measured using EEG, with the additional goal of identifying neurophysiological biomarkers.
Read the detailed description
Participants with a history of acquired brain injury and distal upper limb motor impairments will receive a single two-hour session of SES using transcutaneous electrical nerve stimulation. Pre- and post-intervention assessments consist of the Action Research Arm Test (ARAT), finger fractionation, pinch force, and the modified Ashworth scale (MAS), along with resting-state EEG monitoring. We will assess for any association between SES and changes in motor outcome as measured using the ARAT, MAS and finger fractionation. In addition, EEG power analyses will be performed to determine if there are any differences between SES responders vs. non-responders.
- Conditions
- Stroke
- Being tested
- Transcutaneous electrical nerve stimulation
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous electrical nerve stimulationDevice
TENS is performed using a commercially available device (ProStim, Alimed Inc, Dedham, Massachusetts, USA). One pair of 2 x 3.5 inches rectangular electrodes (Vermed ChroniCare TENS Electrodes, Vermed, Buffalo, NY, USA) are placed to simultaneously stimulate both median and ulnar nerves at the wrist, while a second pair of round 2 inch diameter electrodes are used to stimulate the radial nerve on the forearm. Bursts of electrical stimulation at 10 Hz (100 microsecond pulse width duration) are delivered to all nerves simultaneously for 2 hours.
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Action Research Arm Test (ARAT)
Measured: pre- and immediately post-stimulation
Change in Finger Fractionation
Measured: pre- and immediately post-stimulation
Secondary outcomes (2)
Change in Modified Ashworth Scale (MAS)
Measured: pre- and immediately post-stimulation
Resting State EEG
Measured: pre- 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 posted5 Jun 2017
- Study start1 Aug 2014
- Primary completion30 Apr 2015
- Study completion30 Apr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03176550
- Sponsor's protocol ID
- 13-123462
- Status last verified
- Mar 2020
- First submitted
- 24 May 2017
- Last updated
- 24 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tu-Chan AP, Natraj N, Godlove J, Abrams G, Ganguly K. Effects of somatosensory electrical stimulation on motor function and cortical oscillations. J Neuroeng Rehabil. 2017 Nov 13;14(1):113. doi: 10.1186/s12984-017-0323-1.
PubMed 29132379
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Somatosensory Electrical Simulation On Motor Function and Cortical Oscillations
- ClinicalTrials.gov ID
- NCT03176550
- Acronym / sponsor ID
- 13-123462
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- 1 Aug 2014 (actual)
- Primary completion
- 30 Apr 2015 (actual)
- Study completion
- 30 Apr 2015 (actual)
- First posted
- 5 Jun 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.
Few patients recover full hand dexterity after an acquired brain injury such as stroke. Repetitive somatosensory electrical stimulation (SES) is a promising method to promote recovery of hand function. However, studies using SES have largely focused on gross motor function; it remains unclear if it can modulate distal hand functions such as finger individuation. The specific goal of this study was to monitor the effects of SES on individuation as well as on cortical oscillations measured using EEG, with the additional goal of identifying neurophysiological biomarkers.
Detailed description
Participants with a history of acquired brain injury and distal upper limb motor impairments will receive a single two-hour session of SES using transcutaneous electrical nerve stimulation. Pre- and post-intervention assessments consist of the Action Research Arm Test (ARAT), finger fractionation, pinch force, and the modified Ashworth scale (MAS), along with resting-state EEG monitoring. We will assess for any association between SES and changes in motor outcome as measured using the ARAT, MAS and finger fractionation. In addition, EEG power analyses will be performed to determine if there are any differences between SES responders vs. non-responders.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- between 18-80 years old, with a history of an acquired brain injury resulting in residual hemiparesis or other motor deficits of the arm/hand equal to or more than 6 months prior to enrollment; and capacity to adhere with the schedule of interventions and evaluations determined in the protocol.
Key exclusion criteria (1 listed)
- Subjects are excluded if they met any of the following criteria: currently pregnant; uncontrolled medical conditions; significant cognitive impairment on the Montreal Cognitive Assessment (MoCA ≤ 23); ≤ 10 degrees of active index finger range of motion; significant hand joint deformity; severe active alcohol or drug abuse; significant depression (PHQ-9 ≥15); baseline spasticity score (MAS) >3 for any joint tested (wrist and metacarpophalangeal joint flexion and extension); apraxia screen of Tulia (AST) <5; absent light touch, proprioception, pinprick and vibration sensation on the modified Nottingham Sensory Assessment; no upper limb strength against gravity; severe aphasia; or had an implanted 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 |
|---|---|---|
| Transcutaneous electrical nerve stimulationTENS is performed using a commercially available device (ProStim, Alimed Inc, Dedham, Massachusetts, USA). One pair of 2 x 3.5 inches rectangular electrodes (Vermed ChroniCare TENS Electrodes, Vermed, Buffalo, NY, USA) are placed to simultaneously stimulate both median and ulnar nerves at the wrist, while a second pair of round 2 inch diameter electrodes are used to stimulate the radial nerve on the forearm. Bursts of electrical stimulation at 10 Hz (100 microsecond pulse width duration) are delivered to all nerves simultaneously for 2 hours. | Device | – |
Primary outcome
Change in Action Research Arm Test (ARAT)
Time frame: pre- and immediately post-stimulation
Change in Finger Fractionation
Time frame: pre- and immediately post-stimulation
2 secondary outcomes
Change in Modified Ashworth Scale (MAS)
Time frame: pre- and immediately post-stimulation
Resting State EEG
Time frame: pre- and immediately post-stimulation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2023.
- Derived from this study: PubMed 29132379Tu-Chan AP, Natraj N, Godlove J, Abrams G, Ganguly K. Effects of somatosensory electrical stimulation on motor function and cortical oscillations. J Neuroeng Rehabil. 2017 Nov 13;14(1):113. doi: 10.1186/s12984-017-0323-1.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Transcutaneous electrical nerve stimulation in people with Stroke, run by University of California, San Francisco.
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: finished, as of the sponsor's last update on 24 May 2023. Status can change between updates, so confirm with the study contact before making plans.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 Action Research Arm Test (ARAT) (time frame: pre- and immediately post-stimulation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03176550, which also lists 1 linked publication.
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 24 May 2023.