Upper Extremity DysfunctionNCT04057105
Targeted Noninvasive Brain Stimulation (T-NIBS) to Improve Hand Motor Functions in Acquired Brain Injury
A study testing Active High-definition Transcranial Direct Current Stimulation (HD-tDCS) and MusicGlove in people with Upper Extremity Dysfunction and Traumatic Brain Injury, run by Kessler Foundation at 1 site in United States.
Trial summary
Acquired Brain Injury (TBI) is a serious medical and health problem in the US. Individuals with an acquired brain injury due to stroke and Traumatic Brain Injury (TBI) commonly suffer from upper extremity physical impairments that persist even after years of injury; these deficits are attributed to the damage to brain… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Upper Extremity Dysfunction, Traumatic Brain Injury
- What is being tested?
- Active High-definition Transcranial Direct Current Stimulation (HD-tDCS) and MusicGlove
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2020to 30 Dec 2024
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Confirmed diagnosis of Acquired brain injury (individuals with stroke or Traumatic Brain Injury)
- At least 6 months post-injury
- Complaints of weak movement of hands and fingers
- Ability to understand the instructions that are part of the tDCS-MusicGlove testing and intervention
- Willingness and ability to participate in and travel to Kessler Foundation for the baseline assessment visits, 10 training visits, and post-training follow-up visits
- Ability to sit and be active for 2 hours on a chair (or wheelchair) without cardiac, respiratory and/or pain disturbances as assessed during the screening visit.
- Willingness to give written informed consent.
- Medically stable and not planning for a major change in medications for at least 4 months
Who cannot join
- Unable to move the hand because of muscle stiffness (scoring 3 or more on the Ashworth scale)
- Have lost the sensation of hand movement
- Have a history of alcohol abuse and/or illicit drug use
- Have a problem with the eyesight that would make it difficult to notice the changing instructions on a computer screen
- Currently enrolled in another research study that might affect this research study
- A history of epilepsy (including family members who are diagnosed with epilepsy)
Show all 15Show fewer
- An active history of migraine or chronic headache
- A history of mental illness (e.g. schizophrenia, anxiety, depression, and PTSD)
- Past or current history of treated ringing in the ears known as tinnitus or severe hearing problems
- Have a tattoo with metal-based ink in the head or neck.
- Have severe skin damage on the scalp
- Afraid of confined spaces (claustrophobic)
- Have metallic implants, including intracranial electrodes, surgical clips, shrapnel or a pacemaker.
- Currently taking medications that increase the risk of seizures
- Pregnant
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Targeted Noninvasive Brain Stimulation (T-NIBS) for Upper Extremity Motor Rehabilitation in Acquired Brain Injury (ABI) Patients
Acquired Brain Injury (TBI) is a serious medical and health problem in the US. Individuals with an acquired brain injury due to stroke and Traumatic Brain Injury (TBI) commonly suffer from upper extremity physical impairments that persist even after years of injury; these deficits are attributed to the damage to brain structure and changes in structural and functional connectivity. Although the conventional rehabilitation approaches are helpful in assisting motor recovery often there is a complaint of fatigue due to the repetitive tasks and also, nearly half of the ABI survivors do not regain their ability to use their arms for daily activities.
To address this issue, Dr. Shenoy's proposed study will investigate the combined use of individually targeted non-invasive brain stimulation and music-assisted video game-based hand exercises to achieve functional recovery. Further, the project will also investigate how the intervention modulates brain activity (recorded using EEG) in terms of brain connectivity before- and after the -intervention. In the end, this study will allow us to understand the cortical dynamics of ABI rehabilitation upon brain stimulation. Extending further, this could pave the way to advance the knowledge of behavioral and neural aspects of motor control in patients with different types of neuromuscular disorders.
Read the detailed description
Persistent physical deficits associated with upper extremities including motor weakness, spasticity, and the lack of bimanual coordination of fingers, hands, and arms are particularly problematic as it results in serious disruption of many instrumental activities of daily living. Conventional physical and occupational therapy help improve motor recovery in ABI but nearly 50% of the patients still suffer from a significant level of upper limb motor impairment following rehabilitation, undermining the need for novel therapeutic approaches to improve recovery. Non-invasive brain stimulation (NIBS) techniques such as Transcranial Direct Current Stimulation (tDCS) have shown great promises as adjuvant means to improve the efficacy of neurorehabilitation in Stroke. However, the benefit of combining NIBS with regular motor training has not been extensively studied in the TBI population.
One of the inherent challenges with the approach in dealing with the heterogeneity of the TBI population in terms of the type of injury and the location of the affected cortical region which warrants personalized intervention than a one-size-fits-all approach. Therefore, we propose to develop an individually targeted high-definition tDCS (HD-tDCS) protocol to optimize its effect and achieve maximal upper limb motor recovery in each patient by stimulating the hand knob region which is close to precentral gyrus. HD-tDCS will be combined with MusicGlove exercises (music-assisted repetitive finger movements) to improve the neuroplasticity (adaptation and reorganization to compensate for the initial insult and to attempt to restore function) and fine motor learning while keeping patients engaged. Using a double-blind design, 24 individuals with an acquired brain injury will be randomized to either receive real or sham HD-tDCS during MusicGlove therapy to assess the added benefit of HD-tDCS. In addition, we aim to investigate the underlying neural mechanism of HD-tDCS on motor recovery by studying change in EEG based brain connectivity because of the intervention.
The short-term significance of this project will be to validate the effectiveness of HD-tDCS in ABI neurorehabilitation and help better understand the underlying cortical mechanism of the improvement. In the long-term, the findings of this pilot study will contribute toward the development of an optimal patient-specific rehabilitation therapy to maximize motor recovery in individuals with neuromuscular disorders.
- Being tested
- Active High-definition Transcranial Direct Current Stimulation (HD-tDCS), MusicGlove
- Keywords
- HD-tDCS, TBI, Upper limb rehab, hand dexterity, MusicGlove, Noninvasive Brain Stimulation
- Medical subject headings
- Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active High-definition Transcranial Direct Current Stimulation (HD-tDCS)Device
Stimulation sessions will be conducted once a day on 10 weekdays over a period of 2-3 weeks. Anodal HD-tDCS will be delivered either in Active or Sham mode (as per the randomized order) in a 4x1 ring configuration (center electrode being Anode and the surrounding 4 electrodes being cathodes) over the affected motor area.
MusicGloveDevice
Both groups will undergo MusicGlove video-game based hand exercises.
| Study group | Role | What they receive |
|---|---|---|
| MusicGlove and Active HD-tDCS | Active comparator | During Active HD-tDCS, current up to 2mA will be delivered transiently for only 30 seconds and it will be turned ON for the remainder of 20 minutes. Receives: Device: Active High-definition Transcranial Direct Current Stimulation (HD-tDCS); Device: MusicGlove |
| MusicGlove and Sham HD-tDCS | Sham comparator | During Sham HD-tDCS, current up to 2mA will be delivered transiently for only 30 seconds to simulate the real-tDCS based skin sensation. Receives: Device: MusicGlove |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change scores of Box and Block test (BBT)
BBT is an easy-to-evaluate inexpensive test which mainly evaluates the unilateral gross dexterity. The MusicGlove exercise that is proposed in this study recruits the finger muscles which are for fine motor coordination. During this test, the participant will be asked to move one-by-one, the maximum number of blocks from one compartment of a box to another of equal size, within 60 seconds.
Measured: baseline (before intervention), Post-training (immediately after the end of 2-week intervention), Followup (2 months after the end of intervention)
Change scores of Upper-extremity Fugl-Myer Assessment (UEFMA)
Upper extremity Fugl-Meyer Assessment Score (UEFMA) primarily evaluates the functions of Shoulder/Elbow and Forearm, Wrist, Hand and Coordination and Speed in a series of performed tasks. The maximum score associated with the UE-FMA is 66 points. Each of the 33 specific tasks is scored as either 0 or an absence of function to a maximum score of 2 for the tasks being fully completed. The partial function can be scored as 1 for selected tasks. The change in scores from baseline-to-post-intervention and post-intervention-to-2-month-followup will be assessed.
Measured: baseline (before intervention), Post-training (immediately after the end of 2-week intervention), Followup (2 months after the end of intervention)
Secondary outcomes (6)
Change scores of Action Research Arm Test (ARAT)
ARAT assesses the subject's ability to handle objects differing in size, weight and shape and therefore can be considered to be an arm-specific measure of activity limitation. ARAT is well-suited as a functional outcome measure in this study considering the type of hand exercise intervention.
Measured: baseline (before intervention), Post-training (immediately after the end of 2-week intervention), Followup (2 months after the end of intervention)
Change scores of Nine Hole Peg Test (NHPT)
NHPT is a secondary outcome measure of finger dexterity that can be used in TBI with upper extremity motor deficits. It is considered to be a reliable measure of hand dexterity and recommended for inclusion in NIH toolbox Assessment of Neurological and Behavioral Function. NHPT requires participants to repeatedly place nine pegs into nine holes, one at a time, as quickly as possible and then remove them from the holes. The total time needed to complete the task is then recorded.
Measured: baseline (before intervention), Post-training (immediately after the end of 2-week intervention), Followup (2 months after the end of intervention)
Change scores of Dexterity and Speed Test (DAST)
DAST is exclusively developed for MusicGlove performance assessment, and it was designed to evaluate how well subjects could respond to the sequence of music notes that continuously sped up. This measure is shown to be well correlated with the Box and Block test.
Measured: baseline (before intervention), Post-training (immediately after the end of 2-week intervention), Followup (2 months after the end of intervention)
Changes in the Cortical Excitability using Motor Evoked Potentials (MEP)
MEP outcome measures have become the norm in brain stimulation studies. We hypothesize that the MEP amplitude and latency before- and after-intervention would reveal more information about the neuroplasticity changes during motor recovery. The motor evoked potential (MEP) will be provided by twenty unconditioned stimuli (120% RMT).
Measured: baseline (before intervention), Post-training (immediately after the end of 2-week intervention), Followup (2 months after the end of intervention)
Quality of Life After Brain Injury (QOLIBRI)
Quality of Life After Brain Injury is a self-reported assessment that describes the health-related quality of life after Traumatic Brain Injury. QOLIBRI is specifically tailored for TBI-related dysfunctions.
Measured: baseline (before intervention), Post-training (immediately after the end of 2-week intervention), Followup (2 months after the end of intervention)
Changes in the Functional Connectivity of the brain
Weighted Node degree (as an EEG functional connectivity measure) will reveal the overall importance of an area in the brain network. With the use of EEG-based graph-theoretic measure, we can assess the importance of which particular motor networks are involved in the motor recovery upon intervention.
Measured: baseline (before intervention), Post-training (immediately after the end of 2-week intervention), Followup (2 months after the end of intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2019
- Study start1 Oct 2020
- Primary completion30 Dec 2023
- Study completion30 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Upper Extremity DysfunctionStudies of the same condition, open and under way.
- More trials run by Kessler FoundationThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kessler Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vikram Shenoy Handiru, Kessler Foundation
- Investigators
- Guang Yue, PhD, Study director, Kessler Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04057105
- Sponsor's protocol ID
- R-1067-19
- Status last verified
- Oct 2026
- First submitted
- 29 Jul 2019
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Beaulieu LD, Milot MH. Changes in transcranial magnetic stimulation outcome measures in response to upper-limb physical training in stroke: A systematic review of randomized controlled trials. Ann Phys Rehabil Med. 2018 Jul;61(4):224-234. doi: 10.1016/j.rehab.2017.04.003. Epub 2017 Jun 7.
PubMed 28579362De Vico Fallani F, Richiardi J, Chavez M, Achard S. Graph analysis of functional brain networks: practical issues in translational neuroscience. Philos Trans R Soc Lond B Biol Sci. 2014 Oct 5;369(1653):20130521. doi: 10.1098/rstb.2013.0521.
PubMed 25180301Friedman N, Chan V, Reinkensmeyer AN, Beroukhim A, Zambrano GJ, Bachman M, Reinkensmeyer DJ. Retraining and assessing hand movement after stroke using the MusicGlove: comparison with conventional hand therapy and isometric grip training. J Neuroeng Rehabil. 2014 Apr 30;11:76. doi: 10.1186/1743-0003-11-76.
PubMed 24885076
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Targeted Noninvasive Brain Stimulation (T-NIBS) for Upper Extremity Motor Rehabilitation in Acquired Brain Injury (ABI) Patients
- ClinicalTrials.gov ID
- NCT04057105
- Acronym / sponsor ID
- R-1067-19
- Keywords
- HD-tDCS, TBI, Upper limb rehab, hand dexterity, MusicGlove, Noninvasive Brain Stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Kessler FoundationUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 30 Dec 2023 (actual)
- Study completion
- 30 Dec 2024 (actual)
- First posted
- 15 Aug 2019 (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.
Acquired Brain Injury (TBI) is a serious medical and health problem in the US. Individuals with an acquired brain injury due to stroke and Traumatic Brain Injury (TBI) commonly suffer from upper extremity physical impairments that persist even after years of injury; these deficits are attributed to the damage to brain structure and changes in structural and functional connectivity. Although the conventional rehabilitation approaches are helpful in assisting motor recovery often there is a complaint of fatigue due to the repetitive tasks and also, nearly half of the ABI survivors do not regain their ability to use their arms for daily activities.
To address this issue, Dr. Shenoy's proposed study will investigate the combined use of individually targeted non-invasive brain stimulation and music-assisted video game-based hand exercises to achieve functional recovery. Further, the project will also investigate how the intervention modulates brain activity (recorded using EEG) in terms of brain connectivity before- and after the -intervention. In the end, this study will allow us to understand the cortical dynamics of ABI rehabilitation upon brain stimulation. Extending further, this could pave the way to advance the knowledge of behavioral and neural aspects of motor control in patients with different types of neuromuscular disorders.
Detailed description
Persistent physical deficits associated with upper extremities including motor weakness, spasticity, and the lack of bimanual coordination of fingers, hands, and arms are particularly problematic as it results in serious disruption of many instrumental activities of daily living. Conventional physical and occupational therapy help improve motor recovery in ABI but nearly 50% of the patients still suffer from a significant level of upper limb motor impairment following rehabilitation, undermining the need for novel therapeutic approaches to improve recovery. Non-invasive brain stimulation (NIBS) techniques such as Transcranial Direct Current Stimulation (tDCS) have shown great promises as adjuvant means to improve the efficacy of neurorehabilitation in Stroke. However, the benefit of combining NIBS with regular motor training has not been extensively studied in the TBI population.
One of the inherent challenges with the approach in dealing with the heterogeneity of the TBI population in terms of the type of injury and the location of the affected cortical region which warrants personalized intervention than a one-size-fits-all approach. Therefore, we propose to develop an individually targeted high-definition tDCS (HD-tDCS) protocol to optimize its effect and achieve maximal upper limb motor recovery in each patient by stimulating the hand knob region which is close to precentral gyrus. HD-tDCS will be combined with MusicGlove exercises (music-assisted repetitive finger movements) to improve the neuroplasticity (adaptation and reorganization to compensate for the initial insult and to attempt to restore function) and fine motor learning while keeping patients engaged. Using a double-blind design, 24 individuals with an acquired brain injury will be randomized to either receive real or sham HD-tDCS during MusicGlove therapy to assess the added benefit of HD-tDCS. In addition, we aim to investigate the underlying neural mechanism of HD-tDCS on motor recovery by studying change in EEG based brain connectivity because of the intervention.
The short-term significance of this project will be to validate the effectiveness of HD-tDCS in ABI neurorehabilitation and help better understand the underlying cortical mechanism of the improvement. In the long-term, the findings of this pilot study will contribute toward the development of an optimal patient-specific rehabilitation therapy to maximize motor recovery in individuals with neuromuscular disorders.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MusicGlove and Active HD-tDCS | Active comparator | Device: Active High-definition Transcranial Direct Current Stimulation (HD-tDCS), Device: MusicGloveDuring Active HD-tDCS, current up to 2mA will be delivered transiently for only 30 seconds and it will be turned ON for the remainder of 20 minutes. |
| MusicGlove and Sham HD-tDCS | Sham comparator | Device: MusicGloveDuring Sham HD-tDCS, current up to 2mA will be delivered transiently for only 30 seconds to simulate the real-tDCS based skin sensation. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Confirmed diagnosis of Acquired brain injury (individuals with stroke or Traumatic Brain Injury)
- At least 6 months post-injury
- Complaints of weak movement of hands and fingers
- Ability to understand the instructions that are part of the tDCS-MusicGlove testing and intervention
- Willingness and ability to participate in and travel to Kessler Foundation for the baseline assessment visits, 10 training visits, and post-training follow-up visits
Key exclusion criteria (15 listed)
- Unable to move the hand because of muscle stiffness (scoring 3 or more on the Ashworth scale)
- Have lost the sensation of hand movement
- Have a history of alcohol abuse and/or illicit drug use
- Have a problem with the eyesight that would make it difficult to notice the changing instructions on a computer screen
- Currently enrolled in another research study that might affect this research study
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 |
|---|---|---|
| Active High-definition Transcranial Direct Current Stimulation (HD-tDCS)Stimulation sessions will be conducted once a day on 10 weekdays over a period of 2-3 weeks. Anodal HD-tDCS will be delivered either in Active or Sham mode (as per the randomized order) in a 4x1 ring configuration (center electrode being Anode and the surrounding 4 electrodes being cathodes) over the affected motor area. | Device | MusicGlove and Active HD-tDCS |
| MusicGloveBoth groups will undergo MusicGlove video-game based hand exercises. | Device | MusicGlove and Active HD-tDCS, MusicGlove and Sham HD-tDCS |
Primary outcome
Change scores of Box and Block test (BBT)
Time frame: baseline (before intervention), Post-training (immediately after the end of 2-week intervention), Followup (2 months after the end of intervention)
BBT is an easy-to-evaluate inexpensive test which mainly evaluates the unilateral gross dexterity. The MusicGlove exercise that is proposed in this study recruits the finger muscles which are for fine motor coordination. During this test, the participant will be asked to move one-by-one, the maximum number of blocks from one compartment of a box to another of equal size, within 60 seconds.
Change scores of Upper-extremity Fugl-Myer Assessment (UEFMA)
Time frame: baseline (before intervention), Post-training (immediately after the end of 2-week intervention), Followup (2 months after the end of intervention)
Upper extremity Fugl-Meyer Assessment Score (UEFMA) primarily evaluates the functions of Shoulder/Elbow and Forearm, Wrist, Hand and Coordination and Speed in a series of performed tasks. The maximum score associated with the UE-FMA is 66 points. Each of the 33 specific tasks is scored as either 0 or an absence of function to a maximum score of 2 for the tasks being fully completed. The partial function can be scored as 1 for selected tasks. The change in scores from baseline-to-post-intervention and post-intervention-to-2-month-followup will be assessed.
6 secondary outcomes
Change scores of Action Research Arm Test (ARAT)
Time frame: baseline (before intervention), Post-training (immediately after the end of 2-week intervention), Followup (2 months after the end of intervention)
Change scores of Nine Hole Peg Test (NHPT)
Time frame: baseline (before intervention), Post-training (immediately after the end of 2-week intervention), Followup (2 months after the end of intervention)
Change scores of Dexterity and Speed Test (DAST)
Time frame: baseline (before intervention), Post-training (immediately after the end of 2-week intervention), Followup (2 months after the end of intervention)
Changes in the Cortical Excitability using Motor Evoked Potentials (MEP)
Time frame: baseline (before intervention), Post-training (immediately after the end of 2-week intervention), Followup (2 months after the end of intervention)
Quality of Life After Brain Injury (QOLIBRI)
Time frame: baseline (before intervention), Post-training (immediately after the end of 2-week intervention), Followup (2 months after the end of intervention)
Changes in the Functional Connectivity of the brain
Time frame: baseline (before intervention), Post-training (immediately after the end of 2-week intervention), Followup (2 months after the end of intervention)
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 21 Oct 2026.
- Background: PubMed 28579362Beaulieu LD, Milot MH. Changes in transcranial magnetic stimulation outcome measures in response to upper-limb physical training in stroke: A systematic review of randomized controlled trials. Ann Phys Rehabil Med. 2018 Jul;61(4):224-234. doi: 10.1016/j.rehab.2017.04.003. Epub 2017 Jun 7.
- Background: PubMed 25180301De Vico Fallani F, Richiardi J, Chavez M, Achard S. Graph analysis of functional brain networks: practical issues in translational neuroscience. Philos Trans R Soc Lond B Biol Sci. 2014 Oct 5;369(1653):20130521. doi: 10.1098/rstb.2013.0521.
- Background: PubMed 24885076Friedman N, Chan V, Reinkensmeyer AN, Beroukhim A, Zambrano GJ, Bachman M, Reinkensmeyer DJ. Retraining and assessing hand movement after stroke using the MusicGlove: comparison with conventional hand therapy and isometric grip training. J Neuroeng Rehabil. 2014 Apr 30;11:76. doi: 10.1186/1743-0003-11-76.
- 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.
Guang Yue, PhD study director
Kessler Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active High-definition Transcranial Direct Current Stimulation (HD-tDCS) and MusicGlove in people with Upper Extremity Dysfunction and Traumatic Brain Injury, run by Kessler Foundation 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 8 inclusion and 15 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 21 Oct 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. Some participants in this study may receive a placebo. 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 scores of Box and Block test (BBT) (time frame: baseline (before intervention), Post-training (immediately after the end of 2-week intervention), Followup (2 months after the end of intervention)). 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 NCT04057105, 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 21 Oct 2026.