StrokeNCT05174949
Targeted High-definition Transcranial Direct Current Stimulation (HD-tDCS) for Reducing Post-stroke Movement Impairments
A study testing Transcranial direct current stimulation (high-definition) in people with Stroke, run by University of Oklahoma at 1 site in United States.
Trial summary
Stroke is the leading cause of serious, long-term disability. The emergence of abnormal muscle synergies following a stroke presents a major limitation to the recovery of independent function. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Stroke
- What is being tested?
- Transcranial direct current stimulation (high-definition)
- 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
- 18 Jan 2022to 12 May 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ischemic unilateral stroke lesion (confirmed by the most recent clinical or radiological reports) at least 3 months prior to participation in this project.
- Paresis confined to one side, with moderate to severe motor impairment of the upper limb (Fugl-Meyer upper extremity scores of 10-40)
- Capacity to provide informed consent
Who cannot join
- Muscle tone abnormalities and motor or sensory impairment in the unimpaired limb
- Severe wasting or contracture or significant sensory deficits in the paretic upper limb
- Severe cognitive or affective dysfunction that prevents normal communication and understanding of consent or instruction
- Severe concurrent medical problems (e.g. cardiorespiratory impairment)
- Using a pacemaker
- Metal implants in the head
- Known adverse reaction to TMS and tDCS
- Pregnant
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104-5036
About this study
Official title: Targeted HD-tDCS for Reducing Post-stroke Movement Impairments
Stroke is the leading cause of serious, long-term disability. The emergence of abnormal muscle synergies following a stroke presents a major limitation to the recovery of independent function. Despite the development of many interventions for movement recovery post-stroke, rehabilitation treatments are minimally effective to the muscle synergy impairment. Previous studies have found that muscle synergy impairment is associated with the damage to the corticospinal tract and the maladaptive recruitment of the contralesional cortico-reticulospinal tract. The investigators hypothesize that facilitating the damaged cortico-spinal tract (via primary motor cortex) and/or inhibiting the contralesional cortico-reticulospinal tract (via dorsal premotor cortex) will reduce muscle synergy impairment. In this pilot project, the investigators propose to run a proof-of-concept pilot trial to evaluate the effect of the targeted high-definition transcranial direct current stimulation (HD-tDCS) on mitigating muscle synergy impairment.
Read the detailed description
This randomized, double-blinded, sham-controlled cross-over study will include three stimulation conditions: 1) anodal stimulation over the ipsilesional primary motor cortex, 2) cathodal one over the contralesional premotor cortex, 3) sham stimulation in chronic hemiparetic stroke patients.
Stroke participants (> 3 months after stroke) with moderate to severe motor impairments (Fugl-Meyer Motor Assessment - Upper Extremity score between 10-40, in absence of clinically defined sensory deficits) and an ischemic unilateral subcortical lesion will receive each type of stimulation for 20 minutes.
Their brain activity and behavior data will be collected for the outcome measures.
The patient time commitment in this study is approximately 7 weeks where subjects have 3 x 1-day intervention and measurements, with 2 weeks washout period in between.
The total number of potential enrolled subjects in this pilot study is 12.
- Conditions
- Stroke
- Being tested
- Transcranial direct current stimulation (high-definition)
- Keywords
- Stroke, upper limb impairment, HD-tDCS
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial direct current stimulation (high-definition)Device
Three conditions (2 mA, 20 mins):
- anodal stimulation over the ipsilesional primary motor cortex
- cathodal one over the contralesional premotor cortex
- Sham
| Study group | Role | What they receive |
|---|---|---|
| Sham, Anodal, Cathodal | Experimental | Treatment order 1: Sham, Anodal, Cathodal Receives: Device: Transcranial direct current stimulation (high-definition) |
| Anodal, Cathodal, Sham | Experimental | Treatment order 2: Anodal, Cathodal, Sham Receives: Device: Transcranial direct current stimulation (high-definition) |
| Cathodal, Sham, Anodal | Experimental | Treatment order 3: Cathodal, Sham, Anodal Receives: Device: Transcranial direct current stimulation (high-definition) |
| Sham, Cathodal, Anodal | Experimental | Treatment order 4: Sham, Cathodal, Anodal Receives: Device: Transcranial direct current stimulation (high-definition) |
| Cathodal, Anodal, Sham | Experimental | Treatment order 5: Cathodal, Anodal, Sham Receives: Device: Transcranial direct current stimulation (high-definition) |
| Anodal, Sham, Cathodal | Experimental | Treatment order 6: Anodal, Sham, Cathodal Receives: Device: Transcranial direct current stimulation (high-definition) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fugl-Meyer Upper Extremity Assessment Part A
The Fugl-Meyer Upper Extremity (FM-UE) subset is a component of the Fugl-Meyer Assessment (FM) assessing motor impairment in individuals with stroke or other arm impairments. The (FM-UE) subset focuses on evaluating motor impairment and recovery using movements assessing strength, coordination, sensation, and range of motion of the upper extremity.
Each item in the FM-UE subset is scored on a scale from 0-2. These are added together, with higher scores indicating better motor function. The FM-UE subset has 33 items for a maximum possible (highest functioning) score of 66.
Measured: The FM-UE assessment is completed before and immediately after (within 30 min range) the intervention. The mean difference is then calculated (Post-Pre intenvention) and recorded for each treatment group (anodal, cathodal, and sham). .
Secondary outcomes (1)
Change in Onset Latency of Transcranial Magnetic Stimulation (TMS)-Evoke Motor-evoked Potentials (MEP)
This is a neurophysiological measure that determines the use of ipsilesional corticospinal tract. The paired-pulse TMS was applied at the respective hotspot for the elbow flexor muscle at the paretic arm over the ipsilesional primary motor cortex. The center of the coil was positioned tangentially to the skull. The patient was considered MEP+ if MEPs of any amplitude are observed at a consistent latency on at least 5 out 10 trials. After determining the status of MEP, at least eight more pulses were applied. We calculated average latency across all positive trials to determine the latency of MEP.
Measured: The latency of TMS-evoke MEP assessment is completed before and immediately after (within 30 min range) the intervention. The mean difference is then calculated (Post-Pre intevention) and recorded for each treatment group (anodal, cathodal, and sham).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2022
- Study start18 Jan 2022
- Primary completion12 May 2023
- Study completion12 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This sham-controlled cross-over study design will include three visits: 1) anodal stimulation targeting ipsilesional primary motor cortex, 2) cathodal one at the contralesional premotor cortex, 3) a sham stimulation visit. The sequence of the stimulations will be randomized and double-blinded. After each intervention, there will be at least 2 weeks wash-out period before participants receive the next intervention and assessments.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oklahoma
- Sponsor type
- University, hospital or other
- Collaborators
- Oklahoma Shared Clinical and Translational Resources
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05174949
- Sponsor's protocol ID
- 14011
- Status last verified
- Feb 2024
- First submitted
- 9 Nov 2021
- Last updated
- 29 Jul 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We are committed to enhancing the value of research and furthering the advancement of public knowledge. We recognize that the public dissemination of our scientific results can facilitate the creation of collaborative efforts with domestic and international collaborators. Furthermore, we recognize that the proposed project may result in novel ideas for new methods, technologies, and data that could benefit the entire research community. Therefore, final research data will be shared openly and timely in accordance with the most recent NIH guidelines (http://grants.nih.gov/grants/policy/data\_sharing/) while being mindful that the confidentiality and privacy of participants in research must be protected at all times.
Publications
Williamson J, James SA, Apple B, Sharps J, Sidorov E.V., Yang Y, (2022), High Definition Transcranial Direct Current Stimulation for Improving Upper Extremity Motor Function post Stroke. June 8-10, the 3rd International Workshop on Non-Invasive Brain Stimulation (NIBS) 2022.
Lepak L.V., Cheema C.F, James S.A., Yang Y (2023), Computer-Guided Non-Invasive High-Definition Transcranial Direct Current Brain Stimulation as a Targeted Intervention after a Stroke, American Physical Therapy Association (APTA) Combined Sections Meeting (CSM), San Diego, CA, Feb 23-25, 2023
Williamson JN, James SA, He D, Li S, Sidorov EV, Yang Y. High-definition transcranial direct current stimulation for upper extremity rehabilitation in moderate-to-severe ischemic stroke: a pilot study. Front Hum Neurosci. 2023 Oct 12;17:1286238. doi: 10.3389/fnhum.2023.1286238. eCollection 2023.
PubMed 37900725
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Targeted HD-tDCS for Reducing Post-stroke Movement Impairments
- ClinicalTrials.gov ID
- NCT05174949
- Acronym / sponsor ID
- 14011
- Conditions
- Stroke
- Keywords
- Stroke, upper limb impairment, HD-tDCS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- University of OklahomaUniversity, hospital or other
- Collaborators
- Oklahoma Shared Clinical and Translational Resources
- Study start
- 18 Jan 2022 (actual)
- Primary completion
- 12 May 2023 (actual)
- Study completion
- 12 May 2023 (actual)
- First posted
- 3 Jan 2022 (actual)
- Results
- Posted 29 Jul 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Stroke is the leading cause of serious, long-term disability. The emergence of abnormal muscle synergies following a stroke presents a major limitation to the recovery of independent function. Despite the development of many interventions for movement recovery post-stroke, rehabilitation treatments are minimally effective to the muscle synergy impairment. Previous studies have found that muscle synergy impairment is associated with the damage to the corticospinal tract and the maladaptive recruitment of the contralesional cortico-reticulospinal tract. The investigators hypothesize that facilitating the damaged cortico-spinal tract (via primary motor cortex) and/or inhibiting the contralesional cortico-reticulospinal tract (via dorsal premotor cortex) will reduce muscle synergy impairment. In this pilot project, the investigators propose to run a proof-of-concept pilot trial to evaluate the effect of the targeted high-definition transcranial direct current stimulation (HD-tDCS) on mitigating muscle synergy impairment.
Detailed description
This randomized, double-blinded, sham-controlled cross-over study will include three stimulation conditions: 1) anodal stimulation over the ipsilesional primary motor cortex, 2) cathodal one over the contralesional premotor cortex, 3) sham stimulation in chronic hemiparetic stroke patients.
Stroke participants (> 3 months after stroke) with moderate to severe motor impairments (Fugl-Meyer Motor Assessment - Upper Extremity score between 10-40, in absence of clinically defined sensory deficits) and an ischemic unilateral subcortical lesion will receive each type of stimulation for 20 minutes.
Their brain activity and behavior data will be collected for the outcome measures.
The patient time commitment in this study is approximately 7 weeks where subjects have 3 x 1-day intervention and measurements, with 2 weeks washout period in between.
The total number of potential enrolled subjects in this pilot study is 12.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 6
- Model description
- This sham-controlled cross-over study design will include three visits: 1) anodal stimulation targeting ipsilesional primary motor cortex, 2) cathodal one at the contralesional premotor cortex, 3) a sham stimulation visit. The sequence of the stimulations will be randomized and double-blinded. After each intervention, there will be at least 2 weeks wash-out period before participants receive the next intervention and assessments.
| Arm | Type | Receives |
|---|---|---|
| Sham, Anodal, Cathodal | Experimental | Device: Transcranial direct current stimulation (high-definition)Treatment order 1: Sham, Anodal, Cathodal |
| Anodal, Cathodal, Sham | Experimental | Device: Transcranial direct current stimulation (high-definition)Treatment order 2: Anodal, Cathodal, Sham |
| Cathodal, Sham, Anodal | Experimental | Device: Transcranial direct current stimulation (high-definition)Treatment order 3: Cathodal, Sham, Anodal |
| Sham, Cathodal, Anodal | Experimental | Device: Transcranial direct current stimulation (high-definition)Treatment order 4: Sham, Cathodal, Anodal |
| Cathodal, Anodal, Sham | Experimental | Device: Transcranial direct current stimulation (high-definition)Treatment order 5: Cathodal, Anodal, Sham |
| Anodal, Sham, Cathodal | Experimental | Device: Transcranial direct current stimulation (high-definition)Treatment order 6: Anodal, Sham, Cathodal |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Ischemic unilateral stroke lesion (confirmed by the most recent clinical or radiological reports) at least 3 months prior to participation in this project.
- Paresis confined to one side, with moderate to severe motor impairment of the upper limb (Fugl-Meyer upper extremity scores of 10-40)
- Capacity to provide informed consent
Key exclusion criteria (8 listed)
- Muscle tone abnormalities and motor or sensory impairment in the unimpaired limb
- Severe wasting or contracture or significant sensory deficits in the paretic upper limb
- Severe cognitive or affective dysfunction that prevents normal communication and understanding of consent or instruction
- Severe concurrent medical problems (e.g. cardiorespiratory impairment)
- Using 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 |
|---|---|---|
| Transcranial direct current stimulation (high-definition)Three conditions (2 mA, 20 mins): 1. anodal stimulation over the ipsilesional primary motor cortex 2. cathodal one over the contralesional premotor cortex 3. Sham | Device | Anodal, Cathodal, Sham, Anodal, Sham, Cathodal, Cathodal, Anodal, Sham, Cathodal, Sham, Anodal, Sham, Anodal, Cathodal, Sham, Cathodal, Anodal |
Primary outcome
Fugl-Meyer Upper Extremity Assessment Part A
Time frame: The FM-UE assessment is completed before and immediately after (within 30 min range) the intervention. The mean difference is then calculated (Post-Pre intenvention) and recorded for each treatment group (anodal, cathodal, and sham). .
The Fugl-Meyer Upper Extremity (FM-UE) subset is a component of the Fugl-Meyer Assessment (FM) assessing motor impairment in individuals with stroke or other arm impairments. The (FM-UE) subset focuses on evaluating motor impairment and recovery using movements assessing strength, coordination, sensation, and range of motion of the upper extremity. Each item in the FM-UE subset is scored on a scale from 0-2. These are added together, with higher scores indicating better motor function. The FM-UE subset has 33 items for a maximum possible (highest functioning) score of 66.
1 secondary outcome
Change in Onset Latency of Transcranial Magnetic Stimulation (TMS)-Evoke Motor-evoked Potentials (MEP)
Time frame: The latency of TMS-evoke MEP assessment is completed before and immediately after (within 30 min range) the intervention. The mean difference is then calculated (Post-Pre intevention) and recorded for each treatment group (anodal, cathodal, and sham).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publicationWilliamson J, James SA, Apple B, Sharps J, Sidorov E.V., Yang Y, (2022), High Definition Transcranial Direct Current Stimulation for Improving Upper Extremity Motor Function post Stroke. June 8-10, the 3rd International Workshop on Non-Invasive Brain Stimulation (NIBS) 2022.
- Results publicationLepak L.V., Cheema C.F, James S.A., Yang Y (2023), Computer-Guided Non-Invasive High-Definition Transcranial Direct Current Brain Stimulation as a Targeted Intervention after a Stroke, American Physical Therapy Association (APTA) Combined Sections Meeting (CSM), San Diego, CA, Feb 23-25, 2023
- Derived from this study: PubMed 37900725Williamson JN, James SA, He D, Li S, Sidorov EV, Yang Y. High-definition transcranial direct current stimulation for upper extremity rehabilitation in moderate-to-severe ischemic stroke: a pilot study. Front Hum Neurosci. 2023 Oct 12;17:1286238. doi: 10.3389/fnhum.2023.1286238. eCollection 2023.
- Individual participant dataSharing planned: No. We are committed to enhancing the value of research and furthering the advancement of public knowledge. We recognize that the public dissemination of our scientific results can facilitate the creation of collaborative efforts with domestic and international collaborators. Furthermore, we recognize that the proposed project may result in novel ideas for new methods, technologies, and data that could benefit the entire research community. Therefore, final research data will be shared openly and timely in accordance with the most recent NIH guidelines (http://grants.nih.gov/grants/policy/data_sharing/) while being mindful that the confidentiality and privacy of participants in research must be protected at all times.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial direct current stimulation (high-definition) in people with Stroke, run by University of Oklahoma 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 3 inclusion and 8 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 29 Jul 2024. 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?
Yes. Results are posted in the registry (first posted 29 Jul 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Fugl-Meyer Upper Extremity Assessment Part A (time frame: The FM-UE assessment is completed before and immediately after (within 30 min range) the intervention. The mean difference is then calculated (Post-Pre intenvention) and recorded for each treatment group (anodal, cathodal, and sham). .). 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 NCT05174949, which also lists 3 linked publications.
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 29 Jul 2024.