Trial Outcomes & Findings for CNS Growth Factors Release and Changes in the Inflammatory Environment in Response to Electrical Stimulation in Subjects With Inflammatory Myelopathies (NCT NCT01440452)

Results Overview

We will measure cerebrospinal fluid (CSF) concentrations of BDNF in response to FES ergometry. We will investigate whether there is a correlation between plasma and CSF BDNF concentrations.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

25 participants

Primary outcome timeframe

Baseline

Results posted on

2020-07-17

Participant Flow

Participant milestones

Participant milestones
Measure	Group A For 3 weeks, you will need to come to the International Center for Spinal Cord Injury at Kennedy Krieger Institute (ICSCI) one (1) time per week during which you will perform functional electrical stimulation (FES) cycling for 1 hour each. FES Cycling: You will be seated in your own wheelchair in front of the cycle. We will place your legs onto the cycle and secure them with straps. Electrodes (pads that stick to the skin) will be placed on your skin on your legs and buttock. The pads will be connected to a stimulator box through a wire. We will then start the cycle motor and stimulate your leg and buttock muscles with electric current. This will cause your legs to cycle. You will do this for 1 hour. Lumbar puncture: The study includes 2 lumbar punctures: one at the beginning of the study and one at the end. During a lumbar puncture a small needle will be inserted into the lower back and a small amount of spinal fluid will be drained (about 1 tablespoon).	Group B For 3 weeks, you will need to come to the ICSCI three (3) times per week during which you will perform FES cycling for 1 hour each. FES Cycling: You will be seated in your own wheelchair in front of the cycle. We will place your legs onto the cycle and secure them with straps. Electrodes (pads that stick to the skin) will be placed on your skin on your legs and buttock. The pads will be connected to a stimulator box through a wire. We will then start the cycle motor and stimulate your leg and buttock muscles with electric current. This will cause your legs to cycle. You will do this for 1 hour. Lumbar puncture: The study includes 2 lumbar punctures: one at the beginning of the study and one at the end. During a lumbar puncture a small needle will be inserted into the lower back and a small amount of spinal fluid will be drained (about 1 tablespoon).	Group C For 3 weeks, you will need to come to the ICSCI five (5) times per week during which you will perform FES cycling for 1 hour each. FES Cycling: You will be seated in your own wheelchair in front of the cycle. We will place your legs onto the cycle and secure them with straps. Electrodes (pads that stick to the skin) will be placed on your skin on your legs and buttock. The pads will be connected to a stimulator box through a wire. We will then start the cycle motor and stimulate your leg and buttock muscles with electric current. This will cause your legs to cycle. You will do this for 1 hour. Lumbar puncture: The study includes 2 lumbar punctures: one at the beginning of the study and one at the end. During a lumbar puncture a small needle will be inserted into the lower back and a small amount of spinal fluid will be drained (about 1 tablespoon).	Group D For 3 weeks, you will need to come to the ICSCI three (3) times per week during which you will perform cycling without FES for 1 hour each. Cycling without FES: You will be seated in your own wheelchair in front of the cycle. We will place your legs onto the cycle and secure them with straps. The cycle is configured to work without FES. We will then start the cycle motor. This will cause your legs to cycle. You will do this for 1 hour. Lumbar puncture: The study includes 2 lumbar punctures: one at the beginning of the study and one at the end. During a lumbar puncture a small needle will be inserted into the lower back and a small amount of spinal fluid will be drained (about 1 tablespoon).
Overall Study STARTED	6	7	8	4
Overall Study COMPLETED	6	7	8	4
Overall Study NOT COMPLETED	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Group A n=6 Participants For 3 weeks, you will need to come to the International Center for Spinal Cord Injury at Kennedy Krieger Institute (ICSCI) one (1) time per week during which you will perform FES cycling for 1 hour each. FES Cycling: You will be seated in your own wheelchair in front of the cycle. We will place your legs onto the cycle and secure them with straps. Electrodes (pads that stick to the skin) will be placed on your skin on your legs and buttock. The pads will be connected to a stimulator box through a wire. We will then start the cycle motor and stimulate your leg and buttock muscles with electric current. This will cause your legs to cycle. You will do this for 1 hour. Lumbar puncture: The study includes 2 lumbar punctures: one at the beginning of the study and one at the end. During a lumbar puncture a small needle will be inserted into the lower back and a small amount of spinal fluid will be drained (about 1 tablespoon).	Group B n=7 Participants For 3 weeks, you will need to come to the ICSCI three (3) times per week during which you will perform FES cycling for 1 hour each. FES Cycling: You will be seated in your own wheelchair in front of the cycle. We will place your legs onto the cycle and secure them with straps. Electrodes (pads that stick to the skin) will be placed on your skin on your legs and buttock. The pads will be connected to a stimulator box through a wire. We will then start the cycle motor and stimulate your leg and buttock muscles with electric current. This will cause your legs to cycle. You will do this for 1 hour. Lumbar puncture: The study includes 2 lumbar punctures: one at the beginning of the study and one at the end. During a lumbar puncture a small needle will be inserted into the lower back and a small amount of spinal fluid will be drained (about 1 tablespoon).	Group C n=8 Participants For 3 weeks, you will need to come to the ICSCI five (5) times per week during which you will perform FES cycling for 1 hour each. FES Cycling: You will be seated in your own wheelchair in front of the cycle. We will place your legs onto the cycle and secure them with straps. Electrodes (pads that stick to the skin) will be placed on your skin on your legs and buttock. The pads will be connected to a stimulator box through a wire. We will then start the cycle motor and stimulate your leg and buttock muscles with electric current. This will cause your legs to cycle. You will do this for 1 hour. Lumbar puncture: The study includes 2 lumbar punctures: one at the beginning of the study and one at the end. During a lumbar puncture a small needle will be inserted into the lower back and a small amount of spinal fluid will be drained (about 1 tablespoon).	Group D n=4 Participants For 3 weeks, you will need to come to the ICSCI three (3) times per week during which you will perform cycling without FES for 1 hour each. Cycling without FES: You will be seated in your own wheelchair in front of the cycle. We will place your legs onto the cycle and secure them with straps. The cycle is configured to work without FES. We will then start the cycle motor. This will cause your legs to cycle. You will do this for 1 hour. Lumbar puncture: The study includes 2 lumbar punctures: one at the beginning of the study and one at the end. During a lumbar puncture a small needle will be inserted into the lower back and a small amount of spinal fluid will be drained (about 1 tablespoon).	Total n=25 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=6 Participants	0 Participants n=7 Participants	0 Participants n=8 Participants	0 Participants n=4 Participants	0 Participants n=25 Participants
Age, Categorical Between 18 and 65 years	6 Participants n=6 Participants	7 Participants n=7 Participants	8 Participants n=8 Participants	4 Participants n=4 Participants	25 Participants n=25 Participants
Age, Categorical >=65 years	0 Participants n=6 Participants	0 Participants n=7 Participants	0 Participants n=8 Participants	0 Participants n=4 Participants	0 Participants n=25 Participants
Sex: Female, Male Female	5 Participants n=6 Participants	5 Participants n=7 Participants	4 Participants n=8 Participants	0 Participants n=4 Participants	14 Participants n=25 Participants
Sex: Female, Male Male	1 Participants n=6 Participants	2 Participants n=7 Participants	4 Participants n=8 Participants	4 Participants n=4 Participants	11 Participants n=25 Participants
Race and Ethnicity Not Collected	—	—	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	6 Participants n=6 Participants	7 Participants n=7 Participants	8 Participants n=8 Participants	4 Participants n=4 Participants	25 Participants n=25 Participants

PRIMARY outcome

Timeframe: Baseline

Population: CSF samples were collected, but never run for analysis due to termination of funding. Therefore, no data was collected for this Outcome Measure.

We will measure cerebrospinal fluid (CSF) concentrations of BDNF in response to FES ergometry. We will investigate whether there is a correlation between plasma and CSF BDNF concentrations.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 3 weeks

Population: No data was collected for this assessment.

We will assess mood daily on a Likert scale from 1 (low) to 10 (high) using "Mood24/7".

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline

Population: No data was collected for this assessment.

The MAS is a widely used neurological rating scale, ranging from 0 (normal) to 5. It measures neurological impairment and disability based on the ratings of an observer or neurologist through structured definitions.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline

Population: CSF samples were collected, but never run for analysis due to termination of funding. Therefore, no data was collected for this Outcome Measure.

We will measure CSF concentrations of interleukin (IL)-6, IL-17, tumor necrosis factor (TNF)-α, IL-1ß, IL-23, and IL-12 in response to FES ergometry.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline

Population: Blood samples were collected, but never run for analysis due to termination of funding. Therefore, no data was collected for this Outcome Measure.

We will quantify levels of BDNF in the serum/blood using immunohistochemical quantification methods

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 3 weeks

Population: No data was collected for this assessment.

The MAS is a widely used neurological rating scale, ranging from 0 (normal) to 5. It measures neurological impairment and disability based on the ratings of an observer or neurologist through structured definitions

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 3 weeks

Population: CSF samples were collected, but never run for analysis due to termination of funding. Therefore, no data was collected for this Outcome Measure.

We will measure CSF concentrations of IL-6, IL-17, TNF-α, IL-1ß, IL-23, and IL-12 in response to FES ergometry.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 3 weeks

Population: Blood samples were collected, but never run for analysis due to termination of funding. Therefore, no data was collected for this Outcome Measure.

We will quantify levels of BDNF in the serum/blood using immunohistochemical quantification methods.

Outcome measures

Outcome data not reported

Adverse Events

Group A

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Group B

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Group C

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Group D

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Daniel Becker

Johns Hopkins Hospital

Phone: 4108284629

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place