Trial Outcomes & Findings for Repetitive Transcranial Magnetic Stimulation as Therapy in Hereditary Spastic Paraplegia and Adrenomyeloneuropathy (NCT NCT03627416)
NCT ID: NCT03627416
Last Updated: 2021-09-27
Results Overview
Change in time of walking barefoot the distance of 10 meters with maximal speed, but safely, between baseline and directly after rTMS.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
15 participants
Primary outcome timeframe
Before rTMS, directly (on the same day) after rTMS
Results posted on
2021-09-27
Participant Flow
We recruited 15 patients meeting inclusion criteria. One patient dropped out due to seizure, when he was in active treatment.
Participant milestones
| Measure |
Active rTMS First, Then Sham rTMS
First intervention: 10 hertz (Hz) rTMS will be administered over bilateral primary motor areas for the muscles of lower extremities. Therapy will include five daily sessions (on consecutive week days). In every sessions 3000 magnetic pulses of 90% of the resting motor threshold intensity will be elicited.
The washout will last at least one month.
Second intervention:
Sham stimulation will mimic the active one except that the stimulating coil will be held perpendicularly to the scalp, which assures similar impression as the active stimulation but prevents that significant magnetic field will reach brain tissue.
rTMS: high frequency rTMS to induce the long term potentiation of primary motor areas for the muscles of lower extremities
|
Sham rTMS, Then Active rTMS
First intervention: Sham stimulation will mimic the active one except that the stimulating coil will be held perpendicularly to the scalp, which assures similar impression as the active stimulation but prevents that significant magnetic field will reach brain tissue.
The washout will last at least one month.
Second intervention: 10 hertz (Hz) rTMS will be administered over bilateral primary motor areas for the muscles of lower extremities. Therapy will include five daily sessions (on consecutive week days). In every sessions 3000 magnetic pulses of 90% of the resting motor threshold intensity will be elicited.
rTMS: high frequency rTMS to induce the long term potentiation of primary motor areas for the muscles of lower extremities
|
|---|---|---|
|
Overall Study
STARTED
|
8
|
7
|
|
Overall Study
COMPLETED
|
8
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
Active rTMS First, Then Sham rTMS
First intervention: 10 hertz (Hz) rTMS will be administered over bilateral primary motor areas for the muscles of lower extremities. Therapy will include five daily sessions (on consecutive week days). In every sessions 3000 magnetic pulses of 90% of the resting motor threshold intensity will be elicited.
The washout will last at least one month.
Second intervention:
Sham stimulation will mimic the active one except that the stimulating coil will be held perpendicularly to the scalp, which assures similar impression as the active stimulation but prevents that significant magnetic field will reach brain tissue.
rTMS: high frequency rTMS to induce the long term potentiation of primary motor areas for the muscles of lower extremities
|
Sham rTMS, Then Active rTMS
First intervention: Sham stimulation will mimic the active one except that the stimulating coil will be held perpendicularly to the scalp, which assures similar impression as the active stimulation but prevents that significant magnetic field will reach brain tissue.
The washout will last at least one month.
Second intervention: 10 hertz (Hz) rTMS will be administered over bilateral primary motor areas for the muscles of lower extremities. Therapy will include five daily sessions (on consecutive week days). In every sessions 3000 magnetic pulses of 90% of the resting motor threshold intensity will be elicited.
rTMS: high frequency rTMS to induce the long term potentiation of primary motor areas for the muscles of lower extremities
|
|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Active rTMS, Then Sham rTMS
n=8 Participants
First intervention:
10 hertz (Hz) rTMS will be administered over bilateral primary motor areas for the muscles of lower extremities. Therapy will include five daily sessions (on consecutive week days). In every sessions 3000 magnetic pulses of 90% of the resting motor threshold intensity will be elicited.
The washout period will last at least one month.
Second intervention:
Sham stimulation will mimic the active one except that the stimulating coil will be held perpendicularly to the scalp, which assures similar impression as the active stimulation but prevents that significant magnetic field will reach brain tissue.
rTMS: high frequency rTMS to induce the long term potentiation of primary motor areas for the muscles of lower extremities
|
Sham rTMS, Then Active rTMS
n=7 Participants
First intervention:
Sham stimulation will mimic the active one except that the stimulating coil will be held perpendicularly to the scalp, which assures similar impression as the active stimulation but prevents that significant magnetic field will reach brain tissue.
The washout period will last at least one month.
Second intervention:
10 hertz (Hz) rTMS will be administered over bilateral primary motor areas for the muscles of lower extremities. Therapy will include five daily sessions (on consecutive week days). In every sessions 3000 magnetic pulses of 90% of the resting motor threshold intensity will be elicited.
rTMS: high frequency rTMS to induce the long term potentiation of primary motor areas for the muscles of lower extremities
|
Total
n=15 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=8 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=15 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
8 Participants
n=8 Participants
|
7 Participants
n=7 Participants
|
15 Participants
n=15 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=8 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=15 Participants
|
|
Age, Continuous
|
45.5 years
STANDARD_DEVIATION 11.9 • n=8 Participants
|
41.7 years
STANDARD_DEVIATION 7.5 • n=7 Participants
|
44.8 years
STANDARD_DEVIATION 10.1 • n=15 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=8 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=15 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=8 Participants
|
4 Participants
n=7 Participants
|
10 Participants
n=15 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Poland
|
8 participants
n=8 Participants
|
7 participants
n=7 Participants
|
15 participants
n=15 Participants
|
|
Central motor conduction time
|
18.2 milliseconds
STANDARD_DEVIATION 3.4 • n=8 Participants
|
20.3 milliseconds
STANDARD_DEVIATION 6.6 • n=7 Participants
|
19.1 milliseconds
STANDARD_DEVIATION 5.2 • n=15 Participants
|
|
Amplitude of motor evoked potentials
|
1.1 millivolts
STANDARD_DEVIATION 0.6 • n=8 Participants
|
0.7 millivolts
STANDARD_DEVIATION 0.5 • n=7 Participants
|
0.9 millivolts
STANDARD_DEVIATION 0.5 • n=15 Participants
|
|
Motor threshold for left abductor hallucis
|
64.1 percentage of the maximal stimulator out
STANDARD_DEVIATION 7.5 • n=8 Participants
|
63.5 percentage of the maximal stimulator out
STANDARD_DEVIATION 8.0 • n=7 Participants
|
63.9 percentage of the maximal stimulator out
STANDARD_DEVIATION 7.7 • n=15 Participants
|
|
Motor threshold for the right abductor hallucis
|
61.4 Percentage of the max stimulator output
STANDARD_DEVIATION 12.1 • n=8 Participants
|
62.8 Percentage of the max stimulator output
STANDARD_DEVIATION 8.3 • n=7 Participants
|
62.0 Percentage of the max stimulator output
STANDARD_DEVIATION 10.6 • n=15 Participants
|
PRIMARY outcome
Timeframe: Before rTMS, directly (on the same day) after rTMSChange in time of walking barefoot the distance of 10 meters with maximal speed, but safely, between baseline and directly after rTMS.
Outcome measures
| Measure |
Active rTMS
n=14 Participants
10 hertz (Hz) rTMS will be administered over bilateral primary motor areas for the muscles of lower extremities. Therapy will include five daily sessions (on consecutive week days). In every sessions 3000 magnetic pulses of 90% of the resting motor threshold intensity will be elicited.
rTMS: high frequency rTMS to induce the long term potentiation of primary motor areas for the muscles of lower extremities
|
Sham rTMS
n=14 Participants
Sham stimulation will mimic the active one except that the stimulating coil will be held perpendicularly to the scalp, which assures similar impression as the active stimulation but prevents that significant magnetic field will reach brain tissue.
rTMS: high frequency rTMS to induce the long term potentiation of primary motor areas for the muscles of lower extremities
|
|---|---|---|
|
Change From Baseline Walking Time in 10 Meter Walk Test to the Measurement Taken Directly After rTMS
|
-5.41 seconds
Standard Deviation 16.42
|
1.70 seconds
Standard Deviation 8.52
|
SECONDARY outcome
Timeframe: Baseline, directly (on the same day) after rTMS and 14 days laterTime of standing up from a chair, walking three metres to cross a line drawn 3 meters ahead and going back to sit down on the chair.
Outcome measures
| Measure |
Active rTMS
n=14 Participants
10 hertz (Hz) rTMS will be administered over bilateral primary motor areas for the muscles of lower extremities. Therapy will include five daily sessions (on consecutive week days). In every sessions 3000 magnetic pulses of 90% of the resting motor threshold intensity will be elicited.
rTMS: high frequency rTMS to induce the long term potentiation of primary motor areas for the muscles of lower extremities
|
Sham rTMS
n=14 Participants
Sham stimulation will mimic the active one except that the stimulating coil will be held perpendicularly to the scalp, which assures similar impression as the active stimulation but prevents that significant magnetic field will reach brain tissue.
rTMS: high frequency rTMS to induce the long term potentiation of primary motor areas for the muscles of lower extremities
|
|---|---|---|
|
Change in Timed up and go Test
Baseline vs. 14 days later
|
-2.92 seconds
Standard Deviation 7.29
|
0.78 seconds
Standard Deviation 7.24
|
|
Change in Timed up and go Test
Baseline vs. after rTMS
|
-4.72 seconds
Standard Deviation 13.90
|
0.18 seconds
Standard Deviation 4.83
|
SECONDARY outcome
Timeframe: Baseline, directly (on the same day) after rTMS and 14 days laterChange in bilateral assessment of the strength of following movements: hip flexion, knee flexion and extension, ankle flexion and extension. Assessment will be made according to six degrees (0 to 5) MRC scale, with higher values representing stronger movements, which is better outcome. Values are averaged from all movements tested.
Outcome measures
| Measure |
Active rTMS
n=14 Participants
10 hertz (Hz) rTMS will be administered over bilateral primary motor areas for the muscles of lower extremities. Therapy will include five daily sessions (on consecutive week days). In every sessions 3000 magnetic pulses of 90% of the resting motor threshold intensity will be elicited.
rTMS: high frequency rTMS to induce the long term potentiation of primary motor areas for the muscles of lower extremities
|
Sham rTMS
n=14 Participants
Sham stimulation will mimic the active one except that the stimulating coil will be held perpendicularly to the scalp, which assures similar impression as the active stimulation but prevents that significant magnetic field will reach brain tissue.
rTMS: high frequency rTMS to induce the long term potentiation of primary motor areas for the muscles of lower extremities
|
|---|---|---|
|
Change in Medical Research Council Scale (MRC)
Baseline vs. directly after rTMS
|
0 score on a scale
Standard Deviation 0
|
0.06 score on a scale
Standard Deviation 0.22
|
|
Change in Medical Research Council Scale (MRC)
Baseline vs. 14 days later
|
0.09 score on a scale
Standard Deviation 0.27
|
0 score on a scale
Standard Deviation 0.32
|
SECONDARY outcome
Timeframe: Baseline, directly (on the same day) after rTMS and 14 days laterBilateral assessment of spasticity in following movements: hip flexion, knee flexion and extension, ankle flexion and extension. Assessment will be made according to six degrees (0 to 5) Modified Ashworth Scale, with higher values representing more severe spasticity, which is worse outcome. Values are averaged from all movements tested.
Outcome measures
| Measure |
Active rTMS
n=14 Participants
10 hertz (Hz) rTMS will be administered over bilateral primary motor areas for the muscles of lower extremities. Therapy will include five daily sessions (on consecutive week days). In every sessions 3000 magnetic pulses of 90% of the resting motor threshold intensity will be elicited.
rTMS: high frequency rTMS to induce the long term potentiation of primary motor areas for the muscles of lower extremities
|
Sham rTMS
n=14 Participants
Sham stimulation will mimic the active one except that the stimulating coil will be held perpendicularly to the scalp, which assures similar impression as the active stimulation but prevents that significant magnetic field will reach brain tissue.
rTMS: high frequency rTMS to induce the long term potentiation of primary motor areas for the muscles of lower extremities
|
|---|---|---|
|
Modified Ashworth Scale
Baseline vs. after rTMS
|
-0.36 score on a scale
Standard Deviation 0.50
|
0 score on a scale
Standard Deviation 0.46
|
|
Modified Ashworth Scale
Baseline vs. 14 days later
|
-0.27 score on a scale
Standard Deviation 0.46
|
-0.11 score on a scale
Standard Deviation 0.53
|
SECONDARY outcome
Timeframe: Baseline, 14 days after rTMSChange in time of walking barefoot the distance of 10 meters with maximal speed, but safely, between baseline and 14 days after finishing rTMS therapy.
Outcome measures
| Measure |
Active rTMS
n=14 Participants
10 hertz (Hz) rTMS will be administered over bilateral primary motor areas for the muscles of lower extremities. Therapy will include five daily sessions (on consecutive week days). In every sessions 3000 magnetic pulses of 90% of the resting motor threshold intensity will be elicited.
rTMS: high frequency rTMS to induce the long term potentiation of primary motor areas for the muscles of lower extremities
|
Sham rTMS
n=14 Participants
Sham stimulation will mimic the active one except that the stimulating coil will be held perpendicularly to the scalp, which assures similar impression as the active stimulation but prevents that significant magnetic field will reach brain tissue.
rTMS: high frequency rTMS to induce the long term potentiation of primary motor areas for the muscles of lower extremities
|
|---|---|---|
|
Change From Baseline Walking Time in 10 Meter Walk Test to the Measurement Taken Two Weeks After rTMS
|
-5.84 seconds
Standard Deviation 17.52
|
0.93 seconds
Standard Deviation 6.54
|
Adverse Events
Active rTMS
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Sham rTMS
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Active rTMS
n=15 participants at risk
10 hertz (Hz) rTMS will be administered over bilateral primary motor areas for the muscles of lower extremities. Therapy will include five daily sessions (on consecutive week days). In every sessions 3000 magnetic pulses of 90% of the resting motor threshold intensity will be elicited.
rTMS: high frequency rTMS to induce the long term potentiation of primary motor areas for the muscles of lower extremities
|
Sham rTMS
n=15 participants at risk
Sham stimulation will mimic the active one except that the stimulating coil will be held perpendicularly to the scalp, which assures similar impression as the active stimulation but prevents that significant magnetic field will reach brain tissue.
rTMS: high frequency rTMS to induce the long term potentiation of primary motor areas for the muscles of lower extremities
|
|---|---|---|
|
Nervous system disorders
Seizure
|
6.7%
1/15 • Number of events 1 • 2 years.
|
0.00%
0/15 • 2 years.
|
Other adverse events
| Measure |
Active rTMS
n=15 participants at risk
10 hertz (Hz) rTMS will be administered over bilateral primary motor areas for the muscles of lower extremities. Therapy will include five daily sessions (on consecutive week days). In every sessions 3000 magnetic pulses of 90% of the resting motor threshold intensity will be elicited.
rTMS: high frequency rTMS to induce the long term potentiation of primary motor areas for the muscles of lower extremities
|
Sham rTMS
n=15 participants at risk
Sham stimulation will mimic the active one except that the stimulating coil will be held perpendicularly to the scalp, which assures similar impression as the active stimulation but prevents that significant magnetic field will reach brain tissue.
rTMS: high frequency rTMS to induce the long term potentiation of primary motor areas for the muscles of lower extremities
|
|---|---|---|
|
Nervous system disorders
Sleplessness
|
6.7%
1/15 • Number of events 1 • 2 years.
|
0.00%
0/15 • 2 years.
|
|
Nervous system disorders
Head ache
|
20.0%
3/15 • Number of events 3 • 2 years.
|
0.00%
0/15 • 2 years.
|
Additional Information
Dr. Jakub Antczak
Jagiellonian University Medical College
Phone: +48 795 421 153
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place