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PI left UofL and intends to reopen study at University of Alberta
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This study will examine whether supplementation with the serotonin and dopamine precursors, 5HTP and L-DOPA can alter central nervous system excitability and improve motor function after incomplete and complete spinal cord injuries.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Effects of single-dose of carbidopa (50mg) on CNS excitability | Sham Comparator | Participants will visit the lab and on one of four different occasions they will receive carbidopa only (50 mg). Neurophysiology outcome measures will be obtained at 30, 60, 90, 120 and 150 min post drug-intake. |
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| Effects of single-dose placebo on CNS Excitability | Placebo Comparator | Participants will visit the lab and on one of four different occasions and will receive a placebo. Neurophysiology outcome measures will be obtained at 30, 60, 90, 120 and 150 min post drug-intake. |
|
| Effects of single-dose 5HTP/carbidopa on CNS Excitability | Active Comparator | During one of the four occasions participants visit the lab they will receive 5HTP combined with carbidopa (50-200mg HTP/50mg carbidopa). Neurophysiology outcome measures will be obtained at 30, 60, 90, 120 and 150 min post drug-intake. |
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| Effects of single-dose L-DOPA/carbidopa on CNS Excitability | Active Comparator | During one of the four occasions participants visit the lab they will receive L-DOPA combined with carbidopa (50-200mg L-DOPA/50mg carbidopa). Neurophysiology outcome measures will be obtained at 30, 60, 90, 120 and 150 min post drug-intake. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 5HTP | Drug | 5HTP/carbidopa (50-200 mg 5-HTP/50 mg carbidopa) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in corticospinal excitability | Transcranial magnetic stimulation motor-evoked potentials | Pre drug-intake, 30minutes, 60minutes, 90minutes, 120minutes post drug-intake |
| Change in motoneuron excitability | F waves | Pre drug-intake, 30minutes, 60minutes, 90minutes, 120minutes post drug-intake |
| Change in spinal excitability | H reflex | Pre drug-intake, 30minutes, 60minutes, 90minutes, 120minutes post drug-intake |
| Change in spasticity | Cutaneomuscular reflex | Pre drug-intake, 30minutes, 60minutes, 90minutes, 120minutes post drug-intake |
| Change in movement performance | Leg cycling | Pre drug-intake, 120-150minutes post drug-intake |
| Measure | Description | Time Frame |
|---|---|---|
| Serum Analysis 5-HIAA | 5-HIAA (serum) | 90-120minutes post drug-intake |
| Serum Analysis 5-HT | 5-HT (serum) | 90-120minutes post drug-intake |
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Inclusion Criteria:
Exclusion Criteria:
Patients taking:
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| Name | Affiliation | Role |
|---|---|---|
| Jessica D'Amico, PhD | University of Louisville | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Louisville, Kentucky Spinal Cord Injury Research Centre | Louisville | Kentucky | 40202 | United States |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Feb 18, 2025 | Mar 10, 2025 | 5 |
| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
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| ID | Term |
|---|---|
| D002230 | Carbidopa |
| D007980 | Levodopa |
| C009265 | carbidopa, levodopa drug combination |
| ID | Term |
|---|---|
| D008750 | Methyldopa |
| D004295 | Dihydroxyphenylalanine |
| D002395 | Catecholamines |
| D000588 | Amines |
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Both the participant and assessors are blinded to which drug/placebo the participant reviews because all drugs are housed in similar capsules. Only the PI and caregiver will be aware of which drug will be administered for safety purposes.
| L-DOPA | Drug | L-DOPA/carbidopa (50-200 mg L-DOPA/50 mg carbidopa) |
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| Placebo oral tablet | Drug | Placebo |
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| Carbidopa | Drug | Carbidopa (50mg) |
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| Whole blood analysis 5-HT | 5-HT (whole blood) | 90-120minutes post drug-intake |
| Serum analysis Cortisol | Cortisol level | 90-120minutes post drug-intake |
| Serum and Urine Analysis of dopamine | catecholamines and homovanillic acid (urine) | 90-120min post drug-intake |
| Serum Catechloamines | catecholamines and homovanillic acid (urine) | 90-120minutes post drug-intake |
| Urine Homovanillic acid | homovanillic acid (urine) | 90-120minutes post drug-intake |
| D014947 | Wounds and Injuries |
| D009930 |
| Organic Chemicals |
| D006834 | Hydrazines |
| D002396 | Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D010649 | Phenylalanine |
| D024322 | Amino Acids, Aromatic |
| D000598 | Amino Acids, Cyclic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D014443 | Tyrosine |