Spinal Cord InjuriesIGNITENCT03954496

Improving Hand Recovery With Neuromodulation in Tetraplegia

A study testing transcranial direct current stimulation and Intensive upper extremity motor training in people with Spinal Cord Injuries and Tetraplegia, Unspecified, Incomplete, Chronic, run by Sara Shahid Salles at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

This study will examine a form of non-invasive brain stimulation applied with intensive therapy of the arm and hand. The goal of the study is to determine if arm and hand function can be improved in people with incomplete cervical spinal cord injury (neck spinal cord injury, tetraplegia). Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Spinal Cord Injuries, Tetraplegia, Unspecified, Incomplete, Chronic
What is being tested?: transcranial direct current stimulation and Intensive upper extremity motor training
Type of treatment: Medical device, Lifestyle or therapy programme
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 6 participants
Where: 1 siteUnited States
Study dates: 1 Jul 2019to 24 Mar 2020
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 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

traumatic, incomplete cervical SCI sustained at neurological level C4-C7 and classified as B, C or D by the American Spinal Injury Association Impairment Scale (AIS);
sustained injury at least 1 year prior to enrollment (i.e., chronic); and
Men and women between the ages of 18-65.

Who cannot join

history of head injury, seizures, severe alcohol or drug abuse, or psychiatric illness;
cognitive deficits severe enough to preclude informed consent;
positive pregnancy test or being of childbearing age and not using appropriate contraception;
presence of ferromagnetic material in the cranium except in the mouth, including metal fragments from occupational exposure and surgical clips in or near the brain;
decubitus ulcers that might interfere with intervention;
cardiac or neural pacemakers;

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fixed UE contractures;
untreated depression;
concurrent participation in occupational therapy;
within 3 months of recruitment, an addition or change in the dosage of drugs known to exert detrimental effects on motor recovery.

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Kentucky at Cardinal Hill Rehabilitation Hospital
Lexington, Kentucky, 40504

Other trials in United States

About this study

Read the detailed description

This study will look at the effects of a painless, non-invasive form of brain stimulation, called transcranial direct current stimulation, or tDCS. tDCS is thought to increase the brain's ability to change. Participants will be assigned to one of two groups by chance. One group will receive tDCS at a level expected to increase the brain's ability to change, while the other group will receive tDCS at a level not thought to affect the brain's ability to change. All participants will receive intensive therapy of their more impaired arm and hand, focusing on exercises that are meaningful to him/her.

Conditions: Spinal Cord Injuries, Tetraplegia, Unspecified, Incomplete, Chronic
Being tested: transcranial direct current stimulation, Intensive upper extremity motor training
Keywords: neuroplasticity, rehabilitation, transcranial direct current stimulation, transcranial magnetic stimulation, activities of daily living, motor training
Medical subject headings: Spinal Cord Injuries, Quadriplegia, Bronchiolitis Obliterans Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

transcranial direct current stimulationDevice
This is a non-invasive form of stimulation which delivers safe, low levels of electrical current to the brain through the scalp.
Intensive upper extremity motor trainingBehavioural
This training is administered one-on-one with an occupational therapist. Activities will be focused on skills the participant wants to regain.

Study groups in NCT03954496
Study group	Role	What they receive
Active tDCS	Experimental	Subjects will receive 20 minutes of active transcranial direct current stimulation at 2.5mA, followed by 2 hours of intensive motor therapy of the more affected upper extremity. Receives: Device: transcranial direct current stimulation; Behavioral: Intensive upper extremity motor training
Sham tDCS	Sham comparator	Subjects will receive 20 minutes of sham transcranial direct current stimulation, followed by 2 hours of intensive motor therapy of the more affected upper extremity. Receives: Device: transcranial direct current stimulation; Behavioral: Intensive upper extremity motor training

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Spinal Cord Independence Measure
This evaluates self-care, respiration and sphincter management, and mobility.
Measured: Change from baseline at immediately post-intervention, 1-month follow-up, 4-month follow-up

Secondary outcomes (7)

Change in Medical Research Council Scale Upper Extremity Manual Muscle Test
This evaluates the strength of various muscles in the upper extremity. Each muscle that is tested can be scored from a minimum of 0, indicating no strength, up to a maximum of 5, indicating normal strength. Scores are assigned to each side by summing the scores from each of the 41 individual muscles, with a minimum possible total score of 0 and a maximum possible total score of 205. Higher values indicate greater strength.
Measured: Change from baseline at immediately post-intervention, 1-month follow-up, 4-month follow-up
Change in Canadian Occupational Performance Measure
The participant selects 5 tasks they would like to be able to perform, and score their performance as well as satisfaction with their performance of the tasks.
Measured: Change from baseline at immediately post-intervention, 1-month follow-up, 4-month follow-up
Change in Graded and Redefined Assessment of Strength, Sensibility, and Prehension
This measures strength, sensibility, and prehension to obtain information about motor and sensory function.
Measured: Change from baseline at immediately post-intervention, 1-month follow-up, 4-month follow-up
Change in Van Lieshout Test
This test evaluates upper extremity motor performance in cervical spinal cord injury.
Measured: Change from baseline at immediately post-intervention, 1-month follow-up, 4-month follow-up
Change in cortical motor map volume
This is performed using non-invasive transcranial magnetic stimulation to determine which parts of the brain control a muscle in the arm or hand.
Measured: Change from baseline at immediately post-intervention, 1-month follow-up, 4-month follow-up
Semi-structured interview about study
Participants will be asked about motivations and goals for the study.
Measured: Baseline
Semi-structured interview about study
Participants will be asked about their experience in the study, whether they experienced any changes in function during the study, and whether they have recommendations for change.
Measured: Immediately post-intervention, 4-month follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jul 201924 Mar 2020

First posted17 May 2019
Study start1 Jul 2019
Primary completion24 Mar 2020
Study completion24 Mar 2020

Why it stopped: Insufficient study staff

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Spinal Cord InjuriesStudies 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: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Outcomes assessor
Enrolment: 6 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03954496
Sponsor's protocol ID: 201810171642
Acronym: IGNITE
Status last verified: Jun 2021
First submitted: 14 May 2019
Last updated: 24 Jun 2021
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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MyHand-SCI: An Active Hand Orthosis for Spinal Cord Injury
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Clinical Outcome Assessment for AT & BCI
Spinal Cord Injury, ALS (Amyotrophic Lateral Sclerosis)
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Transcutaneous Spinal Cord Stimulation Combined With 4-Aminopyridine and Intensive Rehabilitation in SCI
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Evaluating the Effect of the Zeen Mobility Device on Clinical Practicality, Safety, and Impact (Via Assessments of Walking, Standing Tolerance, Balance, Endurance, Effort, and Participation in Daily Tasks) in an Outpatient Rehabilitation Setting for Individuals With Mobility Impairments.
Stroke, Parkinson's Disease (PD)
RecruitingPhase 3
A Trial Investigating the Efficacy and Safety of NVG-291 in Subjects With Chronic Spinal Cord Injury
Chronic Spinal Cord Injury

All Spinal Cord Injuries trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Improving Hand Recovery With Neuromodulation in Tetraplegia
ClinicalTrials.gov ID: NCT03954496
Acronym / sponsor ID: IGNITE / 201810171642
Conditions: Spinal Cord Injuries, Tetraplegia, Unspecified, Incomplete, Chronic
Keywords: neuroplasticity, rehabilitation, transcranial direct current stimulation, transcranial magnetic stimulation, activities of daily living, motor training
Study type: Interventional
Recruitment status: TerminatedReason stopped: Insufficient study staff
Enrolment: 6 participants (actual)
Lead sponsor: Sara Shahid SallesUniversity, hospital or other
Collaborators: Wings for Life
Study start: 1 Jul 2019 (actual)
Primary completion: 24 Mar 2020 (actual)
Study completion: 24 Mar 2020 (actual)
First posted: 17 May 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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Active tDCS	Experimental	Device: transcranial direct current stimulation, Behavioral: Intensive upper extremity motor trainingSubjects will receive 20 minutes of active transcranial direct current stimulation at 2.5mA, followed by 2 hours of intensive motor therapy of the more affected upper extremity.
Sham tDCS	Sham comparator	Device: transcranial direct current stimulation, Behavioral: Intensive upper extremity motor trainingSubjects will receive 20 minutes of sham transcranial direct current stimulation, followed by 2 hours of intensive motor therapy of the more affected upper extremity.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

traumatic, incomplete cervical SCI sustained at neurological level C4-C7 and classified as B, C or D by the American Spinal Injury Association Impairment Scale (AIS);
sustained injury at least 1 year prior to enrollment (i.e., chronic); and
Men and women between the ages of 18-65.

Key exclusion criteria (10 listed)

history of head injury, seizures, severe alcohol or drug abuse, or psychiatric illness;
cognitive deficits severe enough to preclude informed consent;
positive pregnancy test or being of childbearing age and not using appropriate contraception;
presence of ferromagnetic material in the cranium except in the mouth, including metal fragments from occupational exposure and surgical clips in or near the brain;
decubitus ulcers that might interfere with intervention;

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 stimulationThis is a non-invasive form of stimulation which delivers safe, low levels of electrical current to the brain through the scalp.	Device	Active tDCS, Sham tDCS
Intensive upper extremity motor trainingThis training is administered one-on-one with an occupational therapist. Activities will be focused on skills the participant wants to regain.	Behavioural	Active tDCS, Sham tDCS

Primary outcome

Change in Spinal Cord Independence Measure
Time frame: Change from baseline at immediately post-intervention, 1-month follow-up, 4-month follow-up
This evaluates self-care, respiration and sphincter management, and mobility.

7 secondary outcomes

Change in Medical Research Council Scale Upper Extremity Manual Muscle Test
Time frame: Change from baseline at immediately post-intervention, 1-month follow-up, 4-month follow-up
Change in Canadian Occupational Performance Measure
Time frame: Change from baseline at immediately post-intervention, 1-month follow-up, 4-month follow-up
Change in Graded and Redefined Assessment of Strength, Sensibility, and Prehension
Time frame: Change from baseline at immediately post-intervention, 1-month follow-up, 4-month follow-up
Change in Van Lieshout Test
Time frame: Change from baseline at immediately post-intervention, 1-month follow-up, 4-month follow-up
Change in cortical motor map volume
Time frame: Change from baseline at immediately post-intervention, 1-month follow-up, 4-month follow-up
Semi-structured interview about study
Time frame: Baseline
Semi-structured interview about study
Time frame: Immediately post-intervention, 4-month follow-up

Results and safety

The study was stopped early (reason given: Insufficient study staff). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2021.
Individual participant dataSharing planned: No

Related trials for Spinal Cord Injuries

Recruiting
MyHand-SCI: An Active Hand Orthosis for Spinal Cord Injury
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Recruiting
Clinical Outcome Assessment for AT & BCI
Spinal Cord Injury, ALS (Amyotrophic Lateral Sclerosis)
Recruiting
Transcutaneous Spinal Cord Stimulation Combined With 4-Aminopyridine and Intensive Rehabilitation in SCI
Spinal Cord Injuries
Not yet recruiting
Evaluating the Effect of the Zeen Mobility Device on Clinical Practicality, Safety, and Impact (Via Assessments of Walking, Standing Tolerance, Balance, Endurance, Effort, and Participation in Daily Tasks) in an Outpatient Rehabilitation Setting for Individuals With Mobility Impairments.
Stroke, Parkinson's Disease (PD)
RecruitingPhase 3
A Trial Investigating the Efficacy and Safety of NVG-291 in Subjects With Chronic Spinal Cord Injury
Chronic Spinal Cord Injury

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.

Sara Salles, MD principal investigator

University of Kentucky

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 10 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: stopped early, as of the sponsor's last update on 24 Jun 2021. 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 was stopped early (reason given: Insufficient study staff). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Spinal Cord Independence Measure (time frame: Change from baseline at immediately post-intervention, 1-month follow-up, 4-month follow-up). 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 NCT03954496.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2021.