Effects of Combined Spinal Direct Current Stimulation on Upper Limb Recovery in Acquired Brain Injury

May 2, 2023 updated by: Gerard Francisco, The University of Texas Health Science Center, Houston

Effects of Combined Spinal Direct Current Stimulation on Upper Limb Recovery in Acquired Brain Injury (ABI)

This study will compare different polarities of transcutaneous spinal direct current stimulation combined with robotic-assisted arm training (RAT) in adults with acquired brain injury (ABI). Participants will receive 20 minutes of 2.5 milliamps (mA) anodal, cathodal, and sham transpinal direct current stimulation (tsDCS) over cervical spine combined with high intensity robotic-assisted arm training, five days a week, for 2 consecutive weeks.

Study Overview

Status

Status

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

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

Acquired brain injury (ABI) is the leading cause of neurological disability in the United States and accounts for the poor physical health and the social dysfunction evident in survivors. Hemiparesis due to acquired brain injury is the primary cause of disability and arm paresis is perceived as the primary cause of disability by individuals who have suffered ABI because of the limitations it creates in performing activities of daily living (ADL). Rehabilitation of the impaired limb is essential for improving motor function after ABI, yet only 31% of ABI survivors receive outpatient rehabilitation. Therefore, effective therapy for upper-limb paresis must be addressed. Approximately 80% of all ABI survivors suffer from upper limb paresis and only 18% of these individuals gain full motor recovery with conventional treatments in the year following ABI.

The study will use cross-over, randomized, sham controlled, double-blinded design. Participants with subacute or chronic ABI will each be assigned to receive active anodal spinal stimulation, active cathodal spinal stimulation, and sham spinal stimulation for the same duration, and the order that each participant will receive anodal, cathodal, and sham stimulation will be randomized. In all the experiments participants will receive robotic assisted training for duration of 1.5 hours. The first 20 minutes of training will be coupled with spinal stimulation. Treatment will be administered at an intensity of 5 sessions per week for 2 weeks.

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.
Interventional

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.
9

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

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

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • The Institute for Rehabilitation and Research (TIRR) at Memorial Hermann

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Providing written informed consent prior to any study related procedures;
  2. Age above 18;
  3. Diagnosis of acquired brain injury at least for 6 month
  4. No neuropsychiatric comorbidities
  5. Not being involved in any specific exercise program (e.g., neuromuscular electrical stimulation (NMES), functional electrical stimulation (FES)) within the previous 3 months;
  6. No planned alteration in upper-extremity therapy or medication for muscle tone during the course of the study;
  7. Eligibility for standard upper-extremity rehabilitation at the time of enrollment (i.e., absence medical comorbidities that would prevent standard rehabilitation);
  8. No condition (e.g., severe arthritis, extreme shoulder pain) that would interfere with valid administration of the measures or with interpreting motor testing;

  9. No contraindications to tsDCS:

    • metal in the head between stimulation area
    • metal in the spine between stimulation area
    • implanted brain medical devices
  10. No pregnancy;
  11. No contraindications for Transcranial Magnetic Stimulation (TMS) and magnetic resonance imaging (MRI) based on TMS and MRI screening forms

Exclusion Criteria:

  1. Uncontrolled epilepsy;
  2. Any joint contracture or severe spasticity in the affected upper extremity, as measured by a Modified Ashworth Score > than 3 out of 4;
  3. History of substance abuse;
  4. Subject who cannot provide self-transportation to the study location

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
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.
Experimental: tsDCS-Anodal & robotic arm training (RAT), then tsDCS-Cathodal & RAT, then tsDCS-Sham & RAT
anodal tsDCS over cervical spine, 2.5mA for 20 minutes
Device: tsDCS-Anodal Stimulation
2.5mA anodal tsDCS over cervical spine for 20 minutes, five days a week, for two weeks. tsDCS electrodes will be placed over cervical spine and shoulder.
Other Names:
  • Transcutaneous Spinal Direct Current Stimulation
Device: tsDCS-Cathodal Stimulation
2.5mA cathodal tsDCS over cervical spine for 20 minutes, five days a week, for two weeks. tsDCS electrodes will be placed over cervical spine and shoulder.
Other Names:
  • Transcutaneous Spinal Direct Current Stimulation
Device: tsDCS-Sham Stimulation
2.5mA sham tsDCS over cervical spine for 20 minutes, five days a week, for two weeks. tsDCS electrodes will be placed over cervical spine and shoulder.
Other Names:
  • Transcutaneous Spinal Direct Current Stimulation
Device: Robotic-assisted training of arm and hand functions
70 minutes of robotic-assisted training (RAT) of arm and hand functions will follow each of the tsDCS sessions, five days a week, for two weeks. Robotic-assisted training will be provided by using the MAHI Exo-II device.
Experimental: tsDCS-Anodal & robotic arm training (RAT), then tsDCS-Sham & RAT, then tsDCS-Cathodal & RAT
cathodal tsDCS over cervical spine, 2.5mA for 20 minutes
Device: tsDCS-Anodal Stimulation
2.5mA anodal tsDCS over cervical spine for 20 minutes, five days a week, for two weeks. tsDCS electrodes will be placed over cervical spine and shoulder.
Other Names:
  • Transcutaneous Spinal Direct Current Stimulation
Device: tsDCS-Cathodal Stimulation
2.5mA cathodal tsDCS over cervical spine for 20 minutes, five days a week, for two weeks. tsDCS electrodes will be placed over cervical spine and shoulder.
Other Names:
  • Transcutaneous Spinal Direct Current Stimulation
Device: tsDCS-Sham Stimulation
2.5mA sham tsDCS over cervical spine for 20 minutes, five days a week, for two weeks. tsDCS electrodes will be placed over cervical spine and shoulder.
Other Names:
  • Transcutaneous Spinal Direct Current Stimulation
Device: Robotic-assisted training of arm and hand functions
70 minutes of robotic-assisted training (RAT) of arm and hand functions will follow each of the tsDCS sessions, five days a week, for two weeks. Robotic-assisted training will be provided by using the MAHI Exo-II device.
Experimental: tsDCS-Cathodal & robotic arm training (RAT), then tsDCS-Anodal & RAT, then tsDCS-Sham & RAT
sham tsDCS over cervical spine, 2.5mA for 20 minutes
Device: tsDCS-Anodal Stimulation
2.5mA anodal tsDCS over cervical spine for 20 minutes, five days a week, for two weeks. tsDCS electrodes will be placed over cervical spine and shoulder.
Other Names:
  • Transcutaneous Spinal Direct Current Stimulation
Device: tsDCS-Cathodal Stimulation
2.5mA cathodal tsDCS over cervical spine for 20 minutes, five days a week, for two weeks. tsDCS electrodes will be placed over cervical spine and shoulder.
Other Names:
  • Transcutaneous Spinal Direct Current Stimulation
Device: tsDCS-Sham Stimulation
2.5mA sham tsDCS over cervical spine for 20 minutes, five days a week, for two weeks. tsDCS electrodes will be placed over cervical spine and shoulder.
Other Names:
  • Transcutaneous Spinal Direct Current Stimulation
Device: Robotic-assisted training of arm and hand functions
70 minutes of robotic-assisted training (RAT) of arm and hand functions will follow each of the tsDCS sessions, five days a week, for two weeks. Robotic-assisted training will be provided by using the MAHI Exo-II device.
Experimental: tsDCS-Cathodal & robotic arm training (RAT), then tsDCS-Sham & RAT, then tsDCS-Anodal & RAT
Device: tsDCS-Anodal Stimulation
2.5mA anodal tsDCS over cervical spine for 20 minutes, five days a week, for two weeks. tsDCS electrodes will be placed over cervical spine and shoulder.
Other Names:
  • Transcutaneous Spinal Direct Current Stimulation
Device: tsDCS-Cathodal Stimulation
2.5mA cathodal tsDCS over cervical spine for 20 minutes, five days a week, for two weeks. tsDCS electrodes will be placed over cervical spine and shoulder.
Other Names:
  • Transcutaneous Spinal Direct Current Stimulation
Device: tsDCS-Sham Stimulation
2.5mA sham tsDCS over cervical spine for 20 minutes, five days a week, for two weeks. tsDCS electrodes will be placed over cervical spine and shoulder.
Other Names:
  • Transcutaneous Spinal Direct Current Stimulation
Device: Robotic-assisted training of arm and hand functions
70 minutes of robotic-assisted training (RAT) of arm and hand functions will follow each of the tsDCS sessions, five days a week, for two weeks. Robotic-assisted training will be provided by using the MAHI Exo-II device.
Experimental: tsDCS-Sham & robotic arm training (RAT), then tsDCS-Anodal & RAT, then tsDCS- Cathodal & RAT
Device: tsDCS-Anodal Stimulation
2.5mA anodal tsDCS over cervical spine for 20 minutes, five days a week, for two weeks. tsDCS electrodes will be placed over cervical spine and shoulder.
Other Names:
  • Transcutaneous Spinal Direct Current Stimulation
Device: tsDCS-Cathodal Stimulation
2.5mA cathodal tsDCS over cervical spine for 20 minutes, five days a week, for two weeks. tsDCS electrodes will be placed over cervical spine and shoulder.
Other Names:
  • Transcutaneous Spinal Direct Current Stimulation
Device: tsDCS-Sham Stimulation
2.5mA sham tsDCS over cervical spine for 20 minutes, five days a week, for two weeks. tsDCS electrodes will be placed over cervical spine and shoulder.
Other Names:
  • Transcutaneous Spinal Direct Current Stimulation
Device: Robotic-assisted training of arm and hand functions
70 minutes of robotic-assisted training (RAT) of arm and hand functions will follow each of the tsDCS sessions, five days a week, for two weeks. Robotic-assisted training will be provided by using the MAHI Exo-II device.
Experimental: tsDCS-Sham & robotic arm training (RAT), then tsDCS-Cathodal & RAT, then tsDCS-Anodal & RAT
Device: tsDCS-Anodal Stimulation
2.5mA anodal tsDCS over cervical spine for 20 minutes, five days a week, for two weeks. tsDCS electrodes will be placed over cervical spine and shoulder.
Other Names:
  • Transcutaneous Spinal Direct Current Stimulation
Device: tsDCS-Cathodal Stimulation
2.5mA cathodal tsDCS over cervical spine for 20 minutes, five days a week, for two weeks. tsDCS electrodes will be placed over cervical spine and shoulder.
Other Names:
  • Transcutaneous Spinal Direct Current Stimulation
Device: tsDCS-Sham Stimulation
2.5mA sham tsDCS over cervical spine for 20 minutes, five days a week, for two weeks. tsDCS electrodes will be placed over cervical spine and shoulder.
Other Names:
  • Transcutaneous Spinal Direct Current Stimulation
Device: Robotic-assisted training of arm and hand functions
70 minutes of robotic-assisted training (RAT) of arm and hand functions will follow each of the tsDCS sessions, five days a week, for two weeks. Robotic-assisted training will be provided by using the MAHI Exo-II device.

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
Fugl-Meyer Arm (FMA) Motor Score
Time Frame: baseline
FMA is a stroke-specific, performance based impairment index. It quantitatively measures impairment based on Twitchell and Brunnstrom's concept of sequential stages of motor return in hemiplegic stroke patients. It uses an ordinal scale for scoring of 33 items for the upper limb component of the F-M scale (0:can not perform; 1:can perform partially; 2:can perform fully). Total range is 0-66, 0 being poor and 66 normal.
baseline
Fugl-Meyer Arm (FMA) Motor Score
Time Frame: 2 weeks
FMA is a stroke-specific, performance based impairment index. It quantitatively measures impairment based on Twitchell and Brunnstrom's concept of sequential stages of motor return in hemiplegic stroke patients. It uses an ordinal scale for scoring of 33 items for the upper limb component of the F-M scale (0:can not perform; 1:can perform partially; 2:can perform fully). Total range is 0-66, 0 being poor and 66 normal.
2 weeks
Fugl-Meyer Arm (FMA) Motor Score
Time Frame: 1 month
FMA is a stroke-specific, performance based impairment index. It quantitatively measures impairment based on Twitchell and Brunnstrom's concept of sequential stages of motor return in hemiplegic stroke patients. It uses an ordinal scale for scoring of 33 items for the upper limb component of the F-M scale (0:can not perform; 1:can perform partially; 2:can perform fully). Total range is 0-66, 0 being poor and 66 normal.
1 month

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
Jebsen Taylor Hand Function Test (JTHFT)
Time Frame: Baseline
The JTHFT is a motor performance test and assesses the time needed to perform 7 everyday activities (for example, flipping cards and feeding). Score is reported as items completed per second.
Baseline
Action Research Arm Test (ARAT)
Time Frame: Baseline
The ARAT is used to assess subject's ability to manipulate-lift-release objects horizontally and vertically, which differs in size, weight and shape. The test consists of 19 items divided into 4 sub-tests (grasp, grip, pinch, gross arm movement) and each item is rated on a 4-point scale. The possible total score ranges between 0-57. Higher scores indicate better performance.
Baseline
Motor Activity Log (MAL)
Time Frame: Baseline
The MAL ranges from 0 to 5, with a higher score indicating greater ability to use the affected arm.
Baseline
Pinch Strength
Time Frame: Baseline
A pinch gauge will be used to measure maximum pinch force.
Baseline
Quantitative Movement Measurement
Time Frame: Change from baseline at 2 weeks and at 1 month
Robotic movement data will be used to quantitatively measure changes in movement smoothness
Change from baseline at 2 weeks and at 1 month
Number of Participants With Adverse Effects Related to tsDCS
Time Frame: Baseline
Safety will be measured by questioning and observing participants at each treatment session. Adverse effects, such as skin redness etc. will be recorded.
Baseline
Jebsen Taylor Hand Function Test (JTHFT)
Time Frame: 2 weeks
The JTHFT is a motor performance test and assesses the time needed to perform 7 everyday activities (for example, flipping cards and feeding). Score is reported as items completed per second.
2 weeks
Jebsen Taylor Hand Function Test (JTHFT)
Time Frame: 1 month
The JTHFT is a motor performance test and assesses the time needed to perform 7 everyday activities (for example, flipping cards and feeding). Score is reported as items completed per second.
1 month
Action Research Arm Test (ARAT)
Time Frame: 2 weeks
The ARAT is used to assess subject's ability to manipulate-lift-release objects horizontally and vertically, which differs in size, weight and shape. The test consists of 19 items divided into 4 sub-tests (grasp, grip, pinch, gross arm movement) and each item is rated on a 4-point scale. The possible total score ranges between 0-57. Higher scores indicate better performance.
2 weeks
Action Research Arm Test (ARAT)
Time Frame: 1 month
The ARAT is used to assess subject's ability to manipulate-lift-release objects horizontally and vertically, which differs in size, weight and shape. The test consists of 19 items divided into 4 sub-tests (grasp, grip, pinch, gross arm movement) and each item is rated on a 4-point scale. The possible total score ranges between 0-57. Higher scores indicate better performance.
1 month
Motor Activity Log (MAL)
Time Frame: 2 weeks
The MAL ranges from 0 to 5, with a higher score indicating greater ability to use the affected arm.
2 weeks
Motor Activity Log (MAL)
Time Frame: 1 month
The MAL ranges from 0 to 5, with a higher score indicating greater ability to use the affected arm.
1 month
Number of Participants With Adverse Effects Related to tsDCS
Time Frame: 2 weeks
Safety will be measured by questioning and observing participants at each treatment session. Adverse effects, such as skin redness etc. will be recorded.
2 weeks
Number of Participants With Adverse Effects Related to tsDCS
Time Frame: 1 month
Safety will be measured by questioning and observing participants at each treatment session. Adverse effects, such as skin redness etc. will be recorded.
1 month
Pinch Strength
Time Frame: 2 weeks
A pinch gauge will be used to measure maximum pinch force.
2 weeks
Pinch Strength
Time Frame: 1 month
A pinch gauge will be used to measure maximum pinch force.
1 month
Grip Strength
Time Frame: baseline
A grip dynamometer will be used to measure maximum gross grasp force.
baseline
Grip Strength
Time Frame: 2 weeks
A grip dynamometer will be used to measure maximum gross grasp force.
2 weeks
Grip Strength
Time Frame: 1 month
A grip dynamometer will be used to measure maximum gross grasp force.
1 month
Spasticity as Assessed by the Modified Ashworth Scale (MAS)
Time Frame: baseline
This test measures spasticity in patients with lesions of the Central Nervous System by testing resistance to passive movement about a joint with varying degrees of velocity. Scores range from 0-4, with 0 indicating normal muscle tone and 4 indicating very high spasticity. The investigators will measure spasticity in the trained upper limb.
baseline
Spasticity as Assessed by the Modified Ashworth Scale (MAS)
Time Frame: 2 weeks
This test measures spasticity in patients with lesions of the Central Nervous System by testing resistance to passive movement about a joint with varying degrees of velocity. Scores range from 0-4, with 0 indicating normal muscle tone and 4 indicating very high spasticity. The investigators will measure spasticity in the trained upper limb.
2 weeks
Spasticity as Assessed by the Modified Ashworth Scale (MAS)
Time Frame: 1 month
This test measures spasticity in patients with lesions of the Central Nervous System by testing resistance to passive movement about a joint with varying degrees of velocity. Scores range from 0-4, with 0 indicating normal muscle tone and 4 indicating very high spasticity. The investigators will measure spasticity in the trained upper limb.
1 month
Spinal Reflexes
Time Frame: Change from baseline at 2 weeks and at 1 month
Change from baseline at 2 weeks and at 1 month
Change in Strength of Selective Muscle Groups
Time Frame: Change from baseline at 2 weeks and at 1 month
Change from baseline at 2 weeks and at 1 month
Neurophysiologic Testing for Spinal Conductivity (SSEP)
Time Frame: Change from baseline at 2 weeks and at 1 month
Change from baseline at 2 weeks and at 1 month

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.
The University of Texas Health Science Center, Houston

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.
  • Principal Investigator: Gerard Francisco, MD, The University of Texas Health Science Center, Houston

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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.
May 1, 2016

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.
December 17, 2019

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.
December 17, 2019

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).
November 23, 2016

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.
March 28, 2017

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.
April 4, 2017

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.
May 25, 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.
May 2, 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.
May 1, 2023

More Information

Terms related to this study

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.
  • HSC-MS-16-0237

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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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