Enhancing Corticospinal Excitability to Improve Functional Recovery
1 other identifier
interventional
19
1 country
1
Brief Summary
Research indicates that increasing brain excitability might help improve hand function in people with spinal cord injury. Brain stimulation that uses electrodes placed on the surface of the scalp (also called "non-invasive brain stimulation") increases brain excitability and has the potential to make it easier for the brain and nervous system to respond to arm and hand training. The purpose of this study is to compare four different types of stimulation for increasing brain excitability to determine which types are best for helping people with tetraplegia improve their ability to use their arms and hands. To fully evaluate the value of brain stimulation on arm and hand function, the investigators will also evaluate the effect of sham (fake) stimulation. Each participant will receive a single session of each of the five types of stimulation being tested.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started May 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 24, 2017
CompletedFirst Posted
Study publicly available on registry
August 2, 2017
CompletedStudy Start
First participant enrolled
May 3, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 27, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
September 27, 2019
CompletedOctober 8, 2019
October 1, 2019
1.4 years
July 24, 2017
October 7, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Change from Baseline Motor Control & Strength
The motor control outcome measure evaluates how quickly the participant can move their fingers. Participants will tap their thumb or index finger as fast as possible for 10 seconds at a time while a sensor counts the number of taps. The strength outcome measure evaluates the participant's hand strength. Participants will use their thumb and index finger to pinch a hand-held device that measures their strength.
Through study completion, up to 5 weeks
Change from Baseline Corticospinal Excitability
This outcome measure evaluates communication between the participant's brain and spinal cord. The skin over the muscles of both arms and hands will be cleaned with an alcohol swab and a mildly abrasive paste (similar to the feel of toothpaste). Sensors that detect muscle activity will be placed over these sites. Pulses of stimulation will be applied to the participant's head using a type of non-invasive brain stimulation called transcranial magnetic stimulation (TMS). This stimulation will activate the brain regions that control arm and hand movement. The strength of the stimulation will be increased until it causes the muscles of the arm and hand to twitch, and the size of the muscle response will be recorded with the sensors placed over the muscles.
Through study completion, up to 5 weeks
Secondary Outcomes (1)
Stimulation Questionnaire
Through study completion, up to 5 weeks
Study Arms (5)
bihemispheric transcranial pulsed current stimulation (tPCS)
EXPERIMENTALunihemispheric transcranial pulsed current stimulation (tPCS)
EXPERIMENTALbihemispheric transcranial direct current stimulation (tDCS)
EXPERIMENTALunihemispheric transcranial direct current stimulation (tDCS)
EXPERIMENTALsham-control
ACTIVE COMPARATORInterventions
Two sets of sponge electrodes (one set placed on each side of the head) will be placed on the participant's head. The transcranial electrical stimulator will apply unidirectional, positive pulses of current separated by brief interpulse intervals to the scalp via the sponges for 30 minutes.
One set of sponge electrodes will be placed on the participant's head. The transcranial electrical stimulator will apply unidirectional, positive pulses of current separated by brief interpulse intervals to the scalp via the sponges for 30 minutes.
Two sets of sponge electrodes (one set placed on each side of the head) will be placed on the participant's head. The transcranial electrical stimulator will apply continuous, direct current to the scalp via the sponges for 30 minutes.
One set of sponge electrodes will be placed on the participant's head. The transcranial electrical stimulator will apply continuous, direct current to the scalp via the sponges for 30 minutes.
Sponge electrodes will be placed on the participant's head. The transcranial electrical stimulator will apply stimulation to the scalp via the sponges for 1-2 minutes. The stimulator will then be turned off.
Eligibility Criteria
You may qualify if:
- Cervical (neurological level C1-C8) SCI occurring more than 6 months ago
- Any severity classification (ASIA/ISNCSCI A, B, C, D)
- Self-reported functional limitation in at least one upper limb
- Ability to voluntarily move thumb or index finger (visible twitch) of both upper limbs
- Ability and willingness to consent to participate in the study and authorize use of protected health information
You may not qualify if:
- Pacemaker or metal implant in the head
- History of seizure
- History of frequent or severe headaches
- Damage to the nerves of the arms/hands (lower motor neuron damage) as documented in medical record, per participant report, or during in-person screening
- Prior tendon or nerve transfer surgery
- Severe pain or hypersensitivity of the arm/hand that would limit participation in arm and hand training
- Severe contractures of the arm/hand that would limit participation in arm and hand training
- Current pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Shepherd Center, Atlanta GAlead
- The Craig H. Neilsen Foundationcollaborator
Study Sites (1)
Shepherd Center
Atlanta, Georgia, 30309, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 24, 2017
First Posted
August 2, 2017
Study Start
May 3, 2018
Primary Completion
September 27, 2019
Study Completion
September 27, 2019
Last Updated
October 8, 2019
Record last verified: 2019-10