Double Dose 4-AP on Functional Recovery After Spinal Cord Injury

ConditionSCI - Spinal Cord Injury

Trial statusRecruiting

Trial phasePhase 1, Phase 2

Trial typeInterventional

Biological sexAll

Age18-85

SponsorShirley Ryan AbilityLab

About this trial

The purpose of this study is to test a strategy to potentiate functional recovery of lower limb motor function in individuals with spinal cord injury (SCI). The FDA approved drug, Dalfampridine (4-AP). 4-AP will be used twice-daily in combination of Spike-timing-dependent plasticity (STDP) stimulation and STDP stimulation with limb training.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Male and females between ages 18-85 years

SCI 6 months post injury

Spinal Cord injury at or above L2

ASIA A, B, C, or D, complete or incomplete

Disqualifiers

Uncontrolled medical problems including pulmonary, cardiovascular or orthopedic disease

Any history of renal impairment

Any debilitating disease prior to the SCI that caused exercise intolerance

Premorbid, ongoing major depression or psychosis, altered cognitive status

Trial design

Design model

Parallel

Treatments tested in this trial

Dalfampridine
Drug
The study drug (4-AP) will be administered as a 10 mg dose twice a day.
Placebo
Drug
The placebo provided by the SRAL pharmacy that looks identical to the 4-AP, will be administered twice a day.
STDP stimulation
Other intervention
Paired stimulation will be given to the spinal cord and to peripheral nerves so that the signals are received at the spinal cord at a specific interval.
Exercise training
Behavioral
Lower-limb exercises will involve over-ground walking, treadmill, walking and stair climbing training.

Treatment groups

27 Participants

are divided into 2 treatment groups

Group A: 4-AP(AM) + STDP stimulation + training + 4-AP(PM)Experimental treatment 3 interventions

Group B: Placebo(AM) + STDP stimulation + training + Placebo(PM)Placebo comparator 3 interventions

Trial outcomes

Primary outcomes

Change in TMEPs

Electrical stimulation will be performed placing the cathode on the upper thoracic between the spinal processes between T3 and T4 vertebrae and the anode at \~10 cm above

Time frame

TMEPs measured at baseline, at 6 weeks (post 20 sessions), and at 12 weeks (post 40 sessions).

Change in MVC

Individuals will perform a maximum voluntary contraction (MVC) of each targeted muscle (quadriceps femoris, tibialis anterior or soleus) through surface electrodes secured to the skin over the belly of each muscle. Ankle flexion torque will be measured by measured by force sensors.

Time frame

MVC measured at baseline, at 6 weeks (post 20 sessions), and at 12 weeks (post 40 sessions).

Secondary outcomes

Change in 10-meter walk test

We will use the 10-meter walk test to quantify walking speed in meters per second. The same percentage of body-weight support will be used during pre- and post-assessments. Less time to walk 10-meter indicates better outcome.

Time frame

10-m walk measured at baseline, at 6 weeks (post 20 sessions), and at 12 weeks (post 40 sessions).

Change in 6-minute walk test

We will measure the distance walked over 6 minutes. The same percentage of body-weight support will be used as in 10-meter walk test. The longer distance walked during 6 minutes indicates better outcome.

Time frame

6-min walk measured at baseline, at 6 weeks (post 20 sessions), and at 12 weeks (post 40 sessions).

Change in International Standards for Neurological Classification of Spinal Cord Injury exam

Motor part of the exam is completed through the testing of key muscle functions corresponding to 10 myotomes (C5-T1 and L2-S1) for right and left side separately. The strength of each muscle function is graded on a six-point scale ranging from 0 meaning complete paralysis to 5 meaning full strength. The total motor score is sum of all motor scores range from 0-100. Sensory part of the exam is completed through the testing of a key point in each of the 28 dermatomes (from C2 to S4-5) on the right and left sides of the body. At each of these key points, two aspects of sensation are examined: light touch and pin prick. Appreciation of light touch and pin prick sensation at each of the key points is separately scored on a three-point scale; 0-absent, 1-altered, and 2-normal or intact. 56 is the maximum score for both light touch and pin prick and the total sensory score ranges from 0 to 112. Higher scores represent better outcome for motor and sensory scores.

Time frame

Scores measured at baseline, at 6 weeks (post 20 sessions), and at 12 weeks (post 40 sessions).

Change in EPT

We use electrical perceptual threshold (EPT) to measures the minimum amount of electrical current that the participant can perceive when applied to the lower limb dermatomes (L2-S2).

Time frame

EPT will be measured at baseline, at 6 weeks (post 20 sessions), and at 12 weeks (post 40 sessions).

Other outcomes

Changes in spinal excitability

We will measure spinal excitability by measuring F-wave and H-reflex in soleus and TA muscles. Post-Activation Depression (PAD) of the H-reflex will also be quantified in soleus muscle

Time frame

Changes in spinal excitability will be measured at baseline, at 6 weeks (post 20 sessions), and at 12 weeks (post 40 sessions).

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shirley Ryan AbilityLab

Lead sponsor

Source ClinicalTrials.gov

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