IR and Microvascular Blood Flow in SCI

NACompletedINTERVENTIONAL
Enrollment

68

Participants

Timeline

Start Date

December 31, 2012

Primary Completion Date

December 31, 2015

Study Completion Date

December 31, 2016

Conditions
Spinal Cord InjuryInsulin Resistance
Interventions
DRUG

Insulin iontophoresis

For insulin iontophoresis, the cathode electrode will contain 0.2 ml of liquid insulin. For preparation and instrumentation, the arms will be uncovered below the elbow; the participant's lower extremities will be uncovered below knee for leg evaluations. The laser Doppler flowmetry (LDF) lead will be placed bilaterally, 2 inches proximal to the lateral malleolus over the peroneus longus muscle. For arm evaluations, a lead will be placed (and secured with dual-sided transparent tape) bilaterally, 2 inches distal to the lateral epicondyle over the flexor carpi ulnaris muscle along the midline with the ulnar process. Baseline and peak cutaneous blood flow responses to application of insulin iontophoresis will be determined for each LDF lead during the evaluation.

DRUG

Placebo Iontophoresis

For placebo iontophoresis, the cathode electrode will contain 0.2 ml of preservative-free normal saline; the anode electrode will contain a medical grade adhesive for skin placement and last 20 minutes. Preparation, instrumentation and data collection for this intervention are the same as the insulin iontophoresis.

DRUG

Acetylcholine Iontophoresis

For acetylcholine iontophoresis, the anode electrode will contain 0.2 ml of 1% acetylcholine chloride; the cathode electrode will contain a medical grade adhesive for skin placement and last 20 minutes. Preparation, instrumentation and data collection for this intervention are the same as the insulin iontophoresis.

OTHER

Heat application

For the provocation with heat, an insulated thermal heat pack (\~106°F) will be applied to the exposed arm or leg for 18 minutes. The thermal heat pack is comparable to what is routinely used as a heat therapy in conventional rehabilitation settings. LDF leads and temperature sensors will be placed in the previously specified locations to evaluate the changes.

Trial Locations (1)

10468

James J. Peters VA Medical Center, The Bronx

All Listed Sponsors
lead

James J. Peters Veterans Affairs Medical Center

FED

NCT02034331 - IR and Microvascular Blood Flow in SCI | Biotech Hunter | Biotech Hunter