Targeted Noninvasive Brain Stimulation to Improve Hand Dexterity in Stroke Patients (T-NIBS)

June 8, 2023 updated by: Vikram Shenoy Handiru, Kessler Foundation

Targeted Noninvasive Brain Stimulation (T-NIBS) for Improving Hand Dexterity in Stroke Patients

This study will investigate the use of High-definition Transcranial Direct Current Stimulation (HD-tDCS) in the functional improvement of hand dexterity while performing music-assisted hand exercises.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Stroke is a serious medical and health problem in the US, and most of the stroke patients suffer from upper-limb motor deficits including weakened hand dexterity. As upper-limb motor functions are crucial for most of the daily living activities, there is a need for effective intervention. The current therapeutic approaches involve intensive physical therapy training involving repetitive tasks which causes fatigue and lack of engagement in the patients. To address this issue, the investigators will investigate the combined use of individually targeted noninvasive brain stimulation (T-NIBS) using High-definition Transcranial Direct Current Stimulation (HD-tDCS) and music-assisted hand exercises using MusicGlove to modulate the neuroplasticity in the desired manner to observe functional changes in hand dexterity.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
7

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • West Orange, New Jersey, United States, 07052-1424
        • Kessler Foundation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Primarily, the stroke survivors from the New Jersey/New York City area. Although not restricted to any primary care clinic, we encourage participants from the Kessler Institute for Rehabilitation.

Description

Inclusion Criteria:

  • Aged between 18-75 years
  • Clinically diagnosed with hemiparetic stroke (weakness on one side - either left or right side of the body)
  • Have had a stroke for more than 6 months
  • Have weakness in moving the fingers of the affected hand
  • Able to understand and perform the instructions that are part of the tDCS-MusicGlove testing and intervention.
  • Willing and able to participate in and travel to Kessler Foundation for the screening session, MRI session, and tDCS-MusicGlove sessions.
  • Able to sit and be active for 1.5 hours during the session without cardiac, respiratory and/or pain disturbances as assessed during the screening visit.
  • Able to provide informed consent.
  • Medically stable and not planning for a major change in medications for at least 4 weeks

Exclusion Criteria:

  • 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 history of smoking within the past 5 years
  • 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)
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Stroke
People suffering from upper-limb motor dysfunction due to stroke
Device: High-definition Transcranial Direct Current Stimulation
Stimulation sessions will be conducted on 2 different visits separated by 2-week gap. In a crossover design, Anodal HD-tDCS will be delivered either in Active/Sham mode (during the first visit) and Sham/Active during the second visit in a 4x1 ring configuration (center electrode being Anode and the surrounding 4 electrodes being cathodes) over the affected motor area.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Changes in the Nine-Hole Peg Test (NHPT) scores
Time Frame: baseline (at day 1), during testing visits (day 2 and day 3)- all within 2 weeks from the screening and consenting
NHPT is a secondary outcome measure of finger dexterity that can be used in stroke patients 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.
baseline (at day 1), during testing visits (day 2 and day 3)- all within 2 weeks from the screening and consenting
Changes in the Dexterity and Speed Test (DAST) scores
Time Frame: baseline (at day 1), during testing visits (day 2 and day 3)- all within 2 weeks from the screening and consenting
DAST is exclusively developed for MusicGlove performance assessment and it is designed to evaluate how fast and accurately do the subjects respond to the sequence of music notes that continuously sped up.
baseline (at day 1), during testing visits (day 2 and day 3)- all within 2 weeks from the screening and consenting

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Changes in the Cortical Excitability using Motor Evoked Potentials (MEP)
Time Frame: baseline (at day 1), during testing visits (day 2 and day 3) - all within 2 weeks from the screening and consenting
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).
baseline (at day 1), during testing visits (day 2 and day 3) - all within 2 weeks from the screening and consenting

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Kessler Foundation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Guang Yue, PhD, Kessler Foundation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 28, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 14, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 31, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 29, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 14, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 15, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 12, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 8, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • R-1056-19

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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