Spastic ParaparesesNCT04287244
Transcutaneous Direct Current Stimulation of the Spinal Cord for Treatment of Spasticity in Multiple Sclerosis
A study testing Transcutaneous Spinal Direct Current Stimulation in people with Spastic Parapareses, run by Lebanese American University.
Trial summary
The current research is aimed at using Transcutaneous Spinal Direct Current Stimulation (tSDCS) as complementary therapeutic tool in the treatment of spasticity in multiple sclerosis. Patients will be randomized into two groups (tSDCS-anode vs. tSDCS-sham) according to the detailed protocol. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spastic Parapareses
- What is being tested?
- Transcutaneous Spinal Direct Current Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Mar 2020to May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- -Patients diagnosed with Multiple Sclerosis according to the 2010 Mc Donald criteria with spasticity in the lower extremities
Who cannot join
- Cardiac pacemakers
- Patients with prior exposure to tDCS
- Metallic hardware in the spine
- Eczema or skin abrasion at the intended site of stimulation
- Currently pregnant or plan for pregnancy in the next 6 months
- Heart or respiratory failure resulting in activity impairment
- Walking impairment due to orthopaedics condition such as deformity or recent fracture.
About this study
The current research is aimed at using Transcutaneous Spinal Direct Current Stimulation (tSDCS) as complementary therapeutic tool in the treatment of spasticity in multiple sclerosis. Patients will be randomized into two groups (tSDCS-anode vs. tSDCS-sham) according to the detailed protocol. Main outcome will be measured by the change in walking speed using the Timed 25-Foot Walk (T25FW).
A total of 40 patients ought to be enrolled as specified in methodology. Secondary outcomes will assess functional improvement through Multiple Sclerosis Walking Scale (MSWS) Short Form - 36 (SF-36), Expanded Disability Status Scale (EDSS) and Ashworth scale.
Read the detailed description
Spasticity is experienced in around 80 % of patients with multiple sclerosis resulting in quality of life impairment. Transcranial direct current stimulation has been proven effective for the treatment of spasticity in patients with chronic stroke or cerebral palsy. The effect of transcutaneous spinal direct current stimulation (tSDCS) has been applied in spasticity but not in patients with spasticity due to multiple sclerosis. The study aims to assess the efficacy of anodal tSDCS on spasticity in multiple sclerosis patients through several assessment tools. The investigators hypothesize that anodal tSDCS will reduce spasticity in multiple sclerosis patients.
The study will be double blind sham-controlled crossover. The patients will be examined by the described assessment tools (T25FW, MSWS, SF-36, Ashworth, EDSS) before receiving tSDCS. The sessions of tSDCS will be applied 1 session per day in 5 consecutive days. Assessment using the scales and questionnaires will be performed at the end of the 5 days of stimulation, 1 week after the last day of first block of sessions and 2 weeks later. The group will be crossed and another block of 5 consecutive days of stimulation will follow. Assessment will take place again on first day and last day of the stimulations followed as well by assessment 1 week after the last day of second block of stimulation and 2 weeks after.
- Conditions
- Spastic Parapareses
- Being tested
- Transcutaneous Spinal Direct Current Stimulation
- Medical subject headings
- Paraparesis, Spastic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous Spinal Direct Current StimulationDevice
tSDCS will be administered through a pair of conductive rubber electrodes covered by saline soaked sponges (35 cm2). The current will be delivered continuously at 2 mA for 30 min through a battery-driven constant-current stimulator (Sooma Oy, Helsinki, Finland).
| Study group | Role | What they receive |
|---|---|---|
| Active tSDCS | Experimental | Anodal tSDCS will be administered through a pair of conductive rubber electrodes covered by saline soaked sponges (35 cm2). The current will be delivered continuously at 2 mA for 30 min through a battery-driven constant-current stimulator (designed by Sooma). The anode will be positioned over the spinal cord area at the level of the spinous processes of 10th-11th thoracic vertebra. Receives: Device: Transcutaneous Spinal Direct Current Stimulation |
| Sham tSDCS | Sham comparator | Sham stimulation will be delivered to the same spinal cord area using a sham tSDCS device that delivers a direct current for 10 seconds at the beginning and end of tSDCS to provide sensory experiences similar to active stimulation. Receives: Device: Transcutaneous Spinal Direct Current Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gait improvement
The primary objective of the study is to achieve 20% gait speed improvement on 25 feet walking test (T25WT) after spasticity reduction by cathodal tSDCS.
Measured: 5 days
Secondary outcomes (4)
Spasticity Assessment
Assessment by Ashworth scale (0-4)
Measured: 19 days
Multiple Sclerosis Walking Assessment
Using Multiple Sclerosis Walking Scale (0-12)
Measured: 19 days
Quality of Life Measures
Assessed through Short Form - 36 (0-100)
Measured: 19 days
Disability Measure
Through Extended Disability Status Scale (0-10)
Measured: 19 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2020
- Study startMar 2020 (estimated)
- Primary completionFeb 2022 (estimated)
- Study completionMay 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spastic ParaparesesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lebanese American University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rechdi Ahdab, Lebanese American University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04287244
- Sponsor's protocol ID
- LAUMCRH.RA4.11/apr/2019
- Status last verified
- Mar 2020
- First submitted
- 19 Feb 2020
- Last updated
- 4 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcutaneous Direct Current Stimulation of the Spinal Cord for Treatment of Spasticity in Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT04287244
- Acronym / sponsor ID
- LAUMCRH.RA4.11/apr/2019
- Conditions
- Spastic Parapareses
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Lebanese American UniversityUniversity, hospital or other
- Study start
- Mar 2020 (estimated)
- Primary completion
- Feb 2022 (estimated)
- Study completion
- May 2022 (estimated)
- First posted
- 27 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The current research is aimed at using Transcutaneous Spinal Direct Current Stimulation (tSDCS) as complementary therapeutic tool in the treatment of spasticity in multiple sclerosis. Patients will be randomized into two groups (tSDCS-anode vs. tSDCS-sham) according to the detailed protocol. Main outcome will be measured by the change in walking speed using the Timed 25-Foot Walk (T25FW).
A total of 40 patients ought to be enrolled as specified in methodology. Secondary outcomes will assess functional improvement through Multiple Sclerosis Walking Scale (MSWS) Short Form - 36 (SF-36), Expanded Disability Status Scale (EDSS) and Ashworth scale.
Detailed description
Spasticity is experienced in around 80 % of patients with multiple sclerosis resulting in quality of life impairment. Transcranial direct current stimulation has been proven effective for the treatment of spasticity in patients with chronic stroke or cerebral palsy. The effect of transcutaneous spinal direct current stimulation (tSDCS) has been applied in spasticity but not in patients with spasticity due to multiple sclerosis. The study aims to assess the efficacy of anodal tSDCS on spasticity in multiple sclerosis patients through several assessment tools. The investigators hypothesize that anodal tSDCS will reduce spasticity in multiple sclerosis patients.
The study will be double blind sham-controlled crossover. The patients will be examined by the described assessment tools (T25FW, MSWS, SF-36, Ashworth, EDSS) before receiving tSDCS. The sessions of tSDCS will be applied 1 session per day in 5 consecutive days. Assessment using the scales and questionnaires will be performed at the end of the 5 days of stimulation, 1 week after the last day of first block of sessions and 2 weeks later. The group will be crossed and another block of 5 consecutive days of stimulation will follow. Assessment will take place again on first day and last day of the stimulations followed as well by assessment 1 week after the last day of second block of stimulation and 2 weeks after.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active tSDCS | Experimental | Device: Transcutaneous Spinal Direct Current StimulationAnodal tSDCS will be administered through a pair of conductive rubber electrodes covered by saline soaked sponges (35 cm2). The current will be delivered continuously at 2 mA for 30 min through a battery-driven constant-current stimulator (designed by Sooma). The anode will be positioned over the spinal cord area at the level of the spinous processes of 10th-11th thoracic vertebra. |
| Sham tSDCS | Sham comparator | Device: Transcutaneous Spinal Direct Current StimulationSham stimulation will be delivered to the same spinal cord area using a sham tSDCS device that delivers a direct current for 10 seconds at the beginning and end of tSDCS to provide sensory experiences similar to active stimulation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- -Patients diagnosed with Multiple Sclerosis according to the 2010 Mc Donald criteria with spasticity in the lower extremities
Key exclusion criteria (7 listed)
- Cardiac pacemakers
- Patients with prior exposure to tDCS
- Metallic hardware in the spine
- Eczema or skin abrasion at the intended site of stimulation
- Currently pregnant or plan for pregnancy in the next 6 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcutaneous Spinal Direct Current StimulationtSDCS will be administered through a pair of conductive rubber electrodes covered by saline soaked sponges (35 cm2). The current will be delivered continuously at 2 mA for 30 min through a battery-driven constant-current stimulator (Sooma Oy, Helsinki, Finland). | Device | Active tSDCS, Sham tSDCS |
Primary outcome
Gait improvement
Time frame: 5 days
The primary objective of the study is to achieve 20% gait speed improvement on 25 feet walking test (T25WT) after spasticity reduction by cathodal tSDCS.
4 secondary outcomes
Spasticity Assessment
Time frame: 19 days
Multiple Sclerosis Walking Assessment
Time frame: 19 days
Quality of Life Measures
Time frame: 19 days
Disability Measure
Time frame: 19 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2020.
Related trials for Spastic Parapareses
RecruitingObservational study
Evaluation of Patients With HAM/TSP
HTLV-I Infection, Tropical Spastic Paraparesis
RecruitingPhase 1/2
Teriflunomide in HTLV-1 Associated Myelopathy/Tropical Spastic Paraparesis
HAM/TSP
Recruiting
Repetitive Transcranial Magnetic Stimulation (rTMS) in MS Induced Spastic Paraparesis
Multiple Sclerosis
Active, not recruiting
Enhancement of Quality of Work And Life
Parkinson Disease, Hereditary Spastic Paraparesis
RecruitingPhase 2
Dolutegravir Versus Dolutegravir in Combination With Tenofovir for the Treatment of HTLV-1 Infection
HTLV-1 Infection, HTLV I Associated Myelopathies
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Transcutaneous Spinal Direct Current Stimulation in people with Spastic Parapareses, run by Lebanese American University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gait improvement (time frame: 5 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2020.