An interventional study of rTMS in Hereditary Spastic Paraplegia and Adrenomyeloneuropathy, sponsored by Jakub Antczak. Completed at 1 site in Poland. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2021-09-27.
Sponsored by Jakub Antczak · Not applicable, Interventional, and Treatment
Hereditary spastic paraplegia (HSP) is the group of inherited disorders, characterized by progressive gait disturbance. There is no established therapy. Adrenoleukodystrophy (AMN) is an x-linked hereditary disease. One of its form, the adrenomyeloneuropathy has the same symptoms as HSP. Current therapeutic options for AMN are very limited. Repetitive Transcranial Magnetic Stimulation (rTMS) is a noninvasive method of modulation of brain plasticity. The purpose of this study is to compare the effectiveness of rTMS in improving the HSP- and AMN-related gait disturbance and other symptoms with sham stimulation.
Intervention will include five daily sessions. In each session 1500 magnetic pulses will be administered to each of both primary motor areas for lower extremities. Assessment of gait and of strength and spasticity of lower extremities will be made before and after therapy, as well as two weeks later.
Hereditary spastic paraplegia (HSP) is a group of inherited disorders, characterized by progressive gait disturbance with weakness and spasticity, which predominate in lower extremities. There is no established therapy. Adrenoleukodystrophy (AMN) is an x-linked hereditary disease. One of its form, the adrenomyeloneuropathy has the same symptoms as HSP. Current therapeutic options for AMN are very limited. Repetitive Transcranial Magnetic Stimulation (rTMS), a noninvasive method of modulation of brain plasticity proved to be effective in improving the gait performance in several conditions such as Parkinson Disease, vascular Parkinsonism, partial spinal cord injury and in post-stroke paresis. Previous studies documented also altered cortical excitability in HSP patients.
The purpose of this study is to compare the effectiveness of 10 hertz (Hz) rTMS over the primary motor cortices in improving the gait and strength and spasticity of lower extremities with sham stimulation in HSP and AMN patients.
Intervention will include five daily sessions. In each session 1500 magnetic pulses will be administered to each of both primary motor areas for lower extremities. Assessment of gait and of strength and spasticity of lower extremities will be made before and after therapy, as well as two weeks later.
50 studies on the registry are indexed under Spastic Paraplegia, Hereditary; 19 are open to participants now.
This study's enrollment of 15 is below the median of 25 across 24 interventional studies indexed under Spastic Paraplegia, Hereditary.
Browse Spastic Paraplegia, Hereditary studies →Jakub Antczak is the lead sponsor of 8 studies on the registry; 5 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
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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.
Device: rTMS
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.
Device: 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
Change in time of walking barefoot the distance of 10 meters with maximal speed, but safely, between baseline and directly after rTMS.
Time frame: Before rTMS, directly (on the same day) after rTMS
Change in Timed up and go Test
Time 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.
Time frame: Baseline, directly (on the same day) after rTMS and 14 days later
Change in Medical Research Council Scale (MRC)
Change 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.
Time frame: Baseline, directly (on the same day) after rTMS and 14 days later
Modified Ashworth Scale
Bilateral 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.
Time frame: Baseline, directly (on the same day) after rTMS and 14 days later
Change From Baseline Walking Time in 10 Meter Walk Test to the Measurement Taken Two Weeks After rTMS
Change in time of walking barefoot the distance of 10 meters with maximal speed, but safely, between baseline and 14 days after finishing rTMS therapy.
Time frame: Baseline, 14 days after rTMS
We recruited 15 patients meeting inclusion criteria. One patient dropped out due to seizure, when he was in active treatment.
| Milestone | Active rTMS First, Then Sham rTMS | Sham rTMS, Then Active rTMS |
|---|---|---|
| Started | 8 | 7 |
| Completed | 8 | 6 |
| Not completed | 0 | 1 |
| Withdrew: Adverse event | 0 | 1 |
Change in time of walking barefoot the distance of 10 meters with maximal speed, but safely, between baseline and directly after rTMS.
| seconds | Active rTMS | Sham rTMS |
|---|---|---|
| Change From Baseline Walking Time in 10 Meter Walk Test to the Measurement Taken Directly After rTMS | -5.41 ± 16.42 | 1.70 ± 8.52 |
Time 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.
| seconds | Active rTMS | Sham rTMS |
|---|---|---|
| Baseline vs. after rTMS | -4.72 ± 13.90 | 0.18 ± 4.83 |
| Baseline vs. 14 days later | -2.92 ± 7.29 | 0.78 ± 7.24 |
Change 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.
| score on a scale | Active rTMS | Sham rTMS |
|---|---|---|
| Baseline vs. directly after rTMS | 0 ± 0 | 0.06 ± 0.22 |
| Baseline vs. 14 days later | 0.09 ± 0.27 | 0 ± 0.32 |
Bilateral 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.
| score on a scale | Active rTMS | Sham rTMS |
|---|---|---|
| Baseline vs. after rTMS | -0.36 ± 0.50 | 0 ± 0.46 |
| Baseline vs. 14 days later | -0.27 ± 0.46 | -0.11 ± 0.53 |
Change in time of walking barefoot the distance of 10 meters with maximal speed, but safely, between baseline and 14 days after finishing rTMS therapy.
| seconds | Active rTMS | Sham rTMS |
|---|---|---|
| Change From Baseline Walking Time in 10 Meter Walk Test to the Measurement Taken Two Weeks After rTMS | -5.84 ± 17.52 | 0.93 ± 6.54 |
Collected over 2 years.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Active rTMS | 0/15 (0%) | 1/15 (6.7%) | 4/15 (26.7%) |
| Sham rTMS | 0/15 (0%) | 0/15 (0%) | 0/15 (0%) |
| Event | Active rTMS | Sham rTMS |
|---|---|---|
| SeizureNervous system disorders | 1/15 | 0/15 |
| Event | Active rTMS | Sham rTMS |
|---|---|---|
| Head acheNervous system disorders | 3/15 | 0/15 |
| SleplessnessNervous system disorders | 1/15 | 0/15 |
| Age, Categorical(Participants) | Active rTMS, Then Sham rTMS | Sham rTMS, Then Active rTMS | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 8 | 7 | 15 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | Active rTMS, Then Sham rTMS | Sham rTMS, Then Active rTMS | Total |
|---|---|---|---|
| Mean | 45.5 ± 11.9 | 41.7 ± 7.5 | 44.8 ± 10.1 |
| Sex: Female, Male(Participants) | Active rTMS, Then Sham rTMS | Sham rTMS, Then Active rTMS | Total |
|---|---|---|---|
| Female | 2 | 3 | 5 |
| Male | 6 | 4 | 10 |
| Race and Ethnicity Not Collected(Participants) | Active rTMS, Then Sham rTMS | Sham rTMS, Then Active rTMS | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Region of Enrollment(participants) | Active rTMS, Then Sham rTMS | Sham rTMS, Then Active rTMS | Total |
|---|---|---|---|
| Poland | 8 | 7 | 15 |
| Central motor conduction time(milliseconds) | Active rTMS, Then Sham rTMS | Sham rTMS, Then Active rTMS | Total |
|---|---|---|---|
| Mean | 18.2 ± 3.4 | 20.3 ± 6.6 | 19.1 ± 5.2 |
| Amplitude of motor evoked potentials(millivolts) | Active rTMS, Then Sham rTMS | Sham rTMS, Then Active rTMS | Total |
|---|---|---|---|
| Mean | 1.1 ± 0.6 | 0.7 ± 0.5 | 0.9 ± 0.5 |
| Motor threshold for left abductor hallucis(percentage of the maximal stimulator out) | Active rTMS, Then Sham rTMS | Sham rTMS, Then Active rTMS | Total |
|---|---|---|---|
| Mean | 64.1 ± 7.5 | 63.5 ± 8.0 | 63.9 ± 7.7 |
1 further baseline measures are reported on the registry.
PDFs hosted by the registry, ClinicalTrials.gov.
This study is completed, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.
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Spastic Paraplegia, Hereditary →
Jakub Antczak