Spinal Cord InjuriesNCT04777149
Random Noise Stimulation to Enhance Cortical Drive & Improve Hand Function
A study testing transcranial Random Noise Stimulation (tRNS) and transcranial Direct Current Stimulation (tDCS) in people with Spinal Cord Injuries and Tetraplegia, run by Shepherd Center, Atlanta GA at 1 site in United States.
Trial summary
Cervical spinal cord injury (SCI) results in hand and arm function impairments and decreased independence in performance of daily activities such as bathing, eating, dressing, writing, or typing. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Spinal Cord Injuries, Tetraplegia, Cervical Spinal Cord Injury
- What is being tested?
- transcranial Random Noise Stimulation (tRNS) and transcranial Direct Current Stimulation (tDCS)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Apr 2021to 10 Aug 2022
- 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
- Spinal Cord Injury level above C8
- ASIA Impairment Scale (AIS) classification level: C, D
- Time since injury: ≥ 1 year
- Active intrinsic hand muscles in at least one UE
- Active extrinsic hand muscles in both UE
- Ability to follow multiple step commands
Show all 9Show fewer
- Ability to communicate pain or discomfort
- Willingness to participate in testing
- Ability to obtain informed consent
Who cannot join
- Implanted metallic device in the head and/ or pacemaker
- History of seizures
- History of severe headaches
- Severe contractures of UE that would limit participation in FTP
- Prior tendon or nerve transfer surgery
- Received Botulinum toxin injection in the tested UE in the last 3 months
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Random Noise Stimulation to Enhance Corticomotor Drive for Improved Hand Function
Cervical spinal cord injury (SCI) results in hand and arm function impairments and decreased independence in performance of daily activities such as bathing, eating, dressing, writing, or typing. Recent approaches that involve the application of non-invasive brain stimulation have the potential to strengthen the remaining connections between the brain and the spinal cord for improved hand function. Combining brain stimulation with performing upper limb functional tasks may further increase the ability of individuals with tetraplegia to use their hands. The purpose of this study is to investigate if "random noise", a special type of brain stimulation that most people cannot feel, can be used to enhance upper limb function in individuals with spinal cord injury. Specifically, the investigators will examine if a combined treatment protocol of random noise and fine motor training results in greater improvements in motor and sensory hand function compared to fine motor training alone.
Read the detailed description
Cervical spinal cord injury (SCI) results in upper extremity (UE) functional impairments that can restrict independence, social participation, and overall quality of life. Evidence shows that short duration of non-invasive brain stimulation (NIBS) can strengthen the transmission of information through the spared corticospinal pathways and improve UE functional recovery in individuals with tetraplegia. Transcranial direct current stimulation (tDCS), which is a clinically accessible NIBS approach, has been used to modulate cortical plasticity and improve hand function. However, the high variability in the reported effects of tDCS raises questions about its clinical value and highlights the need to investigate more robust NIBS protocols. Transcranial random noise stimulation (tRNS) is a novel NIBS approach that produces more consistent facilitatory effects compared to tDCS. TRNS delivers a low alternating current with a continuously changing intensity over a wide frequency range. Further, tRNS has excellent tolerability and no risk of skin burns since it is a polarity independent stimulation approach. When tRNS is applied over the motor cortex, it increases cortical excitability in the hand representation area and enhances motor learning in healthy adults. Despite the potential promise of tRNS in increasing corticomotor drive for improved motor performance, its application in persons with SCI is novel. Therefore, in this study, the investigators propose to use tRNS to augment the therapeutic effects of functional task practice (FTP). Our aim is to compare the efficacy of a 3-day tRNS+FTP protocol on cortical excitability, UE motor, and sensory function to tDCS+FTP and to sham-stimulation+FTP in individuals with tetraplegia.
- Being tested
- transcranial Random Noise Stimulation (tRNS), transcranial Direct Current Stimulation (tDCS), sham-stimulation
- Keywords
- Non-invasive brain stimulation, Hand function, Random noise
- Medical subject headings
- Spinal Cord Injuries, Quadriplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcranial Random Noise Stimulation (tRNS)Other
Two electrodes will be placed over the targeted areas on participant's head. A current of random frequency and intensity will be delivered. TRNS will be applied during the first 20 min of functional task practice.
transcranial Direct Current Stimulation (tDCS)Other
Two electrodes will be placed over the targeted areas on participant's head. A continuous low intensity current will be delivered. TDCS will be applied during the first 20 min of functional task practice.
sham-stimulationOther
Two electrodes will be placed over the targeted areas on participant's head. A continuous low intensity current will be delivered for 1- 2 min.
| Study group | Role | What they receive |
|---|---|---|
| transcranial Random Noise Stimulation (tRNS) | Experimental | Participants in this group will receive a combined intervention (3 days of tRNS during functional task practice and 3 days of sham-stimulation during functional task practice). Receives: Other: transcranial Random Noise Stimulation (tRNS); Other: sham-stimulation |
| transcranial Direct Current Stimulation (tDCS) | Active comparator | Participants in this group will receive a combined intervention (3 days of tDCS during functional task practice and 3 days of sham-stimulation during functional task practice). Receives: Other: transcranial Direct Current Stimulation (tDCS); Other: sham-stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Cortical excitability
The communication between brain and spinal cord will be evaluated. Sensors that detect muscle activity will be placed over hand muscles. Pulses of stimulation will be applied to the head using a type of non-invasive brain stimulation called transcranial magnetic stimulation (TMS). The size of the muscle response will be recorded.
Measured: Baseline; Post Testing Week 1; Post Testing Week 2
Change in Strength (key pinch and grasp strength)
Key pinch and grasp strength will be assessed using a dynamometer.
Measured: Baseline; Post Testing Week 1; Post Testing Week 2
Change in Sensory function (sensation subtest of the Graded Redefined Assessment of Strength Sensibility and Prehension)
Semmes and Weinstein Monofilaments will be applied on 3 dorsal and palmar sensory test locations in each hand. Each location is scored from 0 to 4.
Measured: Baseline; Post Testing Week 1; Post Testing Week 2
Secondary outcomes (3)
Change in Unimanual function (Grasp and Release Test)
Participants will be required to grasp, move, and release six objects of different size and weight. For each task, the number of successful and unsuccessful attempts is 30s will be recorded.
Measured: Baseline; Post Testing Week 1; Post Testing Week 2
Change in Bimanual function (Chedoke Arm and Hand Activity Inventory)
This test consists of 9 functional tasks that require bimanual coordination. Each item is graded on a 7-point activity scale with higher scores suggesting better bimanual function.
Measured: Baseline; Post Testing Week 1; Post Testing Week 2
Change in Sensory Function (revised Nottingham Sensory Assessment)
Tactile sensation, proprioception, stereognosis, and two-point discrimination will be tested. Higher scores indicate better sensory function.
Measured: Baseline; Post Testing Week 1; Post Testing Week 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2021
- Study start12 Apr 2021
- Primary completion10 Aug 2022
- Study completion10 Aug 2022
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
- Crossover
- Model description
- Wash-in control design
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shepherd Center, Atlanta GA
- Sponsor type
- University, hospital or other
- Collaborators
- The Craig H. Neilsen Foundation
- Responsible party
- Sponsor
- Investigators
- Anastasia Zarkou, PT,MS,PhD, Principal investigator, Shepherd Center, Atlanta GA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04777149
- Sponsor's protocol ID
- 762
- Status last verified
- Oct 2022
- First submitted
- 25 Feb 2021
- Last updated
- 26 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Random Noise Stimulation to Enhance Corticomotor Drive for Improved Hand Function
- ClinicalTrials.gov ID
- NCT04777149
- Acronym / sponsor ID
- 762
- Keywords
- Non-invasive brain stimulation, Hand function, Random noise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Shepherd Center, Atlanta GAUniversity, hospital or other
- Collaborators
- The Craig H. Neilsen Foundation
- Study start
- 12 Apr 2021 (actual)
- Primary completion
- 10 Aug 2022 (actual)
- Study completion
- 10 Aug 2022 (actual)
- First posted
- 2 Mar 2021 (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.
Cervical spinal cord injury (SCI) results in hand and arm function impairments and decreased independence in performance of daily activities such as bathing, eating, dressing, writing, or typing. Recent approaches that involve the application of non-invasive brain stimulation have the potential to strengthen the remaining connections between the brain and the spinal cord for improved hand function. Combining brain stimulation with performing upper limb functional tasks may further increase the ability of individuals with tetraplegia to use their hands. The purpose of this study is to investigate if "random noise", a special type of brain stimulation that most people cannot feel, can be used to enhance upper limb function in individuals with spinal cord injury. Specifically, the investigators will examine if a combined treatment protocol of random noise and fine motor training results in greater improvements in motor and sensory hand function compared to fine motor training alone.
Detailed description
Cervical spinal cord injury (SCI) results in upper extremity (UE) functional impairments that can restrict independence, social participation, and overall quality of life. Evidence shows that short duration of non-invasive brain stimulation (NIBS) can strengthen the transmission of information through the spared corticospinal pathways and improve UE functional recovery in individuals with tetraplegia. Transcranial direct current stimulation (tDCS), which is a clinically accessible NIBS approach, has been used to modulate cortical plasticity and improve hand function. However, the high variability in the reported effects of tDCS raises questions about its clinical value and highlights the need to investigate more robust NIBS protocols. Transcranial random noise stimulation (tRNS) is a novel NIBS approach that produces more consistent facilitatory effects compared to tDCS. TRNS delivers a low alternating current with a continuously changing intensity over a wide frequency range. Further, tRNS has excellent tolerability and no risk of skin burns since it is a polarity independent stimulation approach. When tRNS is applied over the motor cortex, it increases cortical excitability in the hand representation area and enhances motor learning in healthy adults. Despite the potential promise of tRNS in increasing corticomotor drive for improved motor performance, its application in persons with SCI is novel. Therefore, in this study, the investigators propose to use tRNS to augment the therapeutic effects of functional task practice (FTP). Our aim is to compare the efficacy of a 3-day tRNS+FTP protocol on cortical excitability, UE motor, and sensory function to tDCS+FTP and to sham-stimulation+FTP in individuals with tetraplegia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Wash-in control design
| Arm | Type | Receives |
|---|---|---|
| transcranial Random Noise Stimulation (tRNS) | Experimental | Other: transcranial Random Noise Stimulation (tRNS), Other: sham-stimulationParticipants in this group will receive a combined intervention (3 days of tRNS during functional task practice and 3 days of sham-stimulation during functional task practice). |
| transcranial Direct Current Stimulation (tDCS) | Active comparator | Other: transcranial Direct Current Stimulation (tDCS), Other: sham-stimulationParticipants in this group will receive a combined intervention (3 days of tDCS during functional task practice and 3 days of sham-stimulation during functional task practice). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Spinal Cord Injury level above C8
- ASIA Impairment Scale (AIS) classification level: C, D
- Time since injury: ≥ 1 year
- Active intrinsic hand muscles in at least one UE
- Active extrinsic hand muscles in both UE
Key exclusion criteria (7 listed)
- Implanted metallic device in the head and/ or pacemaker
- History of seizures
- History of severe headaches
- Severe contractures of UE that would limit participation in FTP
- Prior tendon or nerve transfer surgery
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 Random Noise Stimulation (tRNS)Two electrodes will be placed over the targeted areas on participant's head. A current of random frequency and intensity will be delivered. TRNS will be applied during the first 20 min of functional task practice. | Other | transcranial Random Noise Stimulation (tRNS) |
| transcranial Direct Current Stimulation (tDCS)Two electrodes will be placed over the targeted areas on participant's head. A continuous low intensity current will be delivered. TDCS will be applied during the first 20 min of functional task practice. | Other | transcranial Direct Current Stimulation (tDCS) |
| sham-stimulationTwo electrodes will be placed over the targeted areas on participant's head. A continuous low intensity current will be delivered for 1- 2 min. | Other | transcranial Direct Current Stimulation (tDCS), transcranial Random Noise Stimulation (tRNS) |
Primary outcome
Change in Cortical excitability
Time frame: Baseline; Post Testing Week 1; Post Testing Week 2
The communication between brain and spinal cord will be evaluated. Sensors that detect muscle activity will be placed over hand muscles. Pulses of stimulation will be applied to the head using a type of non-invasive brain stimulation called transcranial magnetic stimulation (TMS). The size of the muscle response will be recorded.
Change in Strength (key pinch and grasp strength)
Time frame: Baseline; Post Testing Week 1; Post Testing Week 2
Key pinch and grasp strength will be assessed using a dynamometer.
Change in Sensory function (sensation subtest of the Graded Redefined Assessment of Strength Sensibility and Prehension)
Time frame: Baseline; Post Testing Week 1; Post Testing Week 2
Semmes and Weinstein Monofilaments will be applied on 3 dorsal and palmar sensory test locations in each hand. Each location is scored from 0 to 4.
3 secondary outcomes
Change in Unimanual function (Grasp and Release Test)
Time frame: Baseline; Post Testing Week 1; Post Testing Week 2
Change in Bimanual function (Chedoke Arm and Hand Activity Inventory)
Time frame: Baseline; Post Testing Week 1; Post Testing Week 2
Change in Sensory Function (revised Nottingham Sensory Assessment)
Time frame: Baseline; Post Testing Week 1; Post Testing Week 2
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 26 Oct 2022.
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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.
Anastasia Zarkou, PT,MS,PhD principal investigator
Shepherd Center, Atlanta GA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing transcranial Random Noise Stimulation (tRNS) and transcranial Direct Current Stimulation (tDCS) in people with Spinal Cord Injuries and Tetraplegia, run by Shepherd Center, Atlanta GA 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 9 inclusion and 7 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 26 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
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 in Cortical excitability (time frame: Baseline; Post Testing Week 1; Post Testing Week 2). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Oct 2022.