Multiple SclerosisNCT05560139
The Effect of Transcranial Direct Current Stimulation on Fatigue Among Multiple Sclerosis Patients.Patients
A study testing a-tDCS in people with Multiple Sclerosis, run by Assiut University.
Trial summary
This work is aimed to assess the long term effect of TDCS in fatigue management among MS patients Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- a-tDCS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2022to 1 Sep 2023
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Any adult patient will be fulfilling diagnostic criteria of Multiple sclerosis and could be providing consent for participation in the study, will be included in the study.
Who cannot join
- any patient showed this following condition will be excluded from the study;
- Any MS patient had any contraindication condition to use TMS or TCDS (such as epilepsy, head trauma, metallic procedure, cerebral insult)
- Any patient had infection or febrile condition.
- Any patient had other co morbid neurological or psychiatric disorders or systemic disease.
- Any patient refuses participation in study.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Effect of Transcranial Direct Current Stimulation on Fatigue Among Multiple Sclerosis Patients
This work is aimed to assess the long term effect of TDCS in fatigue management among MS patients
Read the detailed description
Multiple sclerosis (MS) is an inflammatory demyelinating disease of the central nervous system that is considered one of the most frequent causes of disability in the young adult.
Fatigue in MS may affect up to 80 % of the people with MS. It tends to persist over time once it appears. However, despite high frequency, fatigue remains poorly understood. Fatigue in MS is neither consistently linked to disease severity nor disease duration, although it is found to be worse in individuals with the secondary progressive subtype.
Fatigue is distinct from sleepiness, and fails to improve with adequate sleep. Multiple factors are thought to contribute to fatigue[7 , 8] with no specific biomarker or etiology yet confirmed.
A wide variety of therapies have been tested to reduce fatigue in MS, but unfortunately, none have been consistently effective. Transcranial direct current stimulation (tDCS) is a relatively recent therapeutic development that utilizes low-amplitude direct currents to induce changes in cortical excitability. Although various non-invasive neuromodulation technologies are available , tDCS has unique advantages compared to other stimulation methods such as its ease of use, lower cost, and greater safety and tolerability.
Small preliminary studies have observed that tDCS may be a promising treatment for MS fatigue, using sham-controlled crossover designs, with five tDCS sessions, using either a motor, sensory, or dorsolateral prefrontal cortex (DLPFC). Recently Chalah et al.[12] study demonstrated that DLPFC (left anodal) when compared the posterior parietal cortex led to the most fatigue specific improvements.
Thus, tDCS can reduce fatigue burden for people with MS, it may be possible to implement a tDCS therapy for symptomatic management of fatigue.
- Conditions
- Multiple Sclerosis
- Being tested
- a-tDCS
- Keywords
- Multiple sclerosis, Transcranial direct current stimulation, fatigue
- Medical subject headings
- Multiple Sclerosis, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
a-tDCSDevice
Transcranial direct current stimulation
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | Participants in the experimental groups received ten -sessions a-tDCS (1.5mA, 20minutes) anodal stimulation of left DLPC over two weeks duration (five sessions per week). Receives: Device: a-tDCS |
| sham group | Sham comparator | The sham group received ten sessions of sham stimulation for 20-minutes in each session. Receives: Device: a-tDCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
fatigue assessment scale
it is a acale filed by the patient and it consists of scale from 1 to 10
Measured: at post sessions, 1 month and 2 month post sessions
visual analogue scale
it is a scale from 0 to 10 to assess major fatigue
Measured: at post sessions, 1 month and 2 month post sessions
Secondary outcomes (1)
changes in cortical excitability parameters at post 10th session compared to baseline measurements of cortical excitability parameters
Detection of the relationship between cortical excitability changes{after 10th session) and changes in fatigue and HDS and QLoL changes..
Measured: at post sessions, 1 month and 2 month post sessions
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2022
- Study start1 Dec 2022 (estimated)
- Primary completion1 May 2023 (estimated)
- Study completion1 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Parallel groups
- Model description
- A randomized clinical trial-controlled study to assess the ability of tDCS; anodal stimulation of left DLPC versus sham stimulation in improving fatigue in MS patients
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Entsar Karem Abd Elazeem, Assiut University
- Investigators
- Noha M Abo-Elfetoh, PHD, Study chair, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05560139
- Sponsor's protocol ID
- TCDCS in MS
- Status last verified
- Sep 2022
- First submitted
- 18 May 2022
- Last updated
- 29 Sep 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Transcranial Direct Current Stimulation on Fatigue Among Multiple Sclerosis Patients
- ClinicalTrials.gov ID
- NCT05560139
- Acronym / sponsor ID
- TCDCS in MS
- Conditions
- Multiple Sclerosis
- Keywords
- Multiple sclerosis, Transcranial direct current stimulation, fatigue
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Dec 2022 (estimated)
- Primary completion
- 1 May 2023 (estimated)
- Study completion
- 1 Sep 2023 (estimated)
- First posted
- 29 Sep 2022 (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.
This work is aimed to assess the long term effect of TDCS in fatigue management among MS patients
Detailed description
Multiple sclerosis (MS) is an inflammatory demyelinating disease of the central nervous system that is considered one of the most frequent causes of disability in the young adult.
Fatigue in MS may affect up to 80 % of the people with MS. It tends to persist over time once it appears. However, despite high frequency, fatigue remains poorly understood. Fatigue in MS is neither consistently linked to disease severity nor disease duration, although it is found to be worse in individuals with the secondary progressive subtype.
Fatigue is distinct from sleepiness, and fails to improve with adequate sleep. Multiple factors are thought to contribute to fatigue[7 , 8] with no specific biomarker or etiology yet confirmed.
A wide variety of therapies have been tested to reduce fatigue in MS, but unfortunately, none have been consistently effective. Transcranial direct current stimulation (tDCS) is a relatively recent therapeutic development that utilizes low-amplitude direct currents to induce changes in cortical excitability. Although various non-invasive neuromodulation technologies are available , tDCS has unique advantages compared to other stimulation methods such as its ease of use, lower cost, and greater safety and tolerability.
Small preliminary studies have observed that tDCS may be a promising treatment for MS fatigue, using sham-controlled crossover designs, with five tDCS sessions, using either a motor, sensory, or dorsolateral prefrontal cortex (DLPFC). Recently Chalah et al.[12] study demonstrated that DLPFC (left anodal) when compared the posterior parietal cortex led to the most fatigue specific improvements.
Thus, tDCS can reduce fatigue burden for people with MS, it may be possible to implement a tDCS therapy for symptomatic management of fatigue.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- A randomized clinical trial-controlled study to assess the ability of tDCS; anodal stimulation of left DLPC versus sham stimulation in improving fatigue in MS patients
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Device: a-tDCSParticipants in the experimental groups received ten -sessions a-tDCS (1.5mA, 20minutes) anodal stimulation of left DLPC over two weeks duration (five sessions per week). |
| sham group | Sham comparator | Device: a-tDCSThe sham group received ten sessions of sham stimulation for 20-minutes in each session. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Any adult patient will be fulfilling diagnostic criteria of Multiple sclerosis and could be providing consent for participation in the study, will be included in the study.
Key exclusion criteria (5 listed)
- any patient showed this following condition will be excluded from the study;
- Any MS patient had any contraindication condition to use TMS or TCDS (such as epilepsy, head trauma, metallic procedure, cerebral insult)
- Any patient had infection or febrile condition.
- Any patient had other co morbid neurological or psychiatric disorders or systemic disease.
- Any patient refuses participation in study.
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 |
|---|---|---|
| a-tDCSTranscranial direct current stimulation | Device | experimental group, sham group |
Primary outcome
fatigue assessment scale
Time frame: at post sessions, 1 month and 2 month post sessions
it is a acale filed by the patient and it consists of scale from 1 to 10
visual analogue scale
Time frame: at post sessions, 1 month and 2 month post sessions
it is a scale from 0 to 10 to assess major fatigue
1 secondary outcome
changes in cortical excitability parameters at post 10th session compared to baseline measurements of cortical excitability parameters
Time frame: at post sessions, 1 month and 2 month post sessions
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2022.
- Compston A, Coles A. Multiple sclerosis. Lancet.Link provided by the sponsor.
- Tellez N et al. Fatigue in multiple sclerosis persists over time: a longitudinal study. J NeurolLink provided by the sponsor.
- Krupp L. Fatigue is intrinsic to multiple sclerosis (MS) and is the most commonly reported symptom of the disease. Mult SclerLink provided by the sponsor.
- Ghajarzadeh M, Jalilian R, Eskandari G, et al. Fatigue in multiple sclerosis: Relationship with disease duration, physical disability, disease pattern, age and sex. Acta Neurol BelgLink provided by the sponsor.
- Chen MY, Wang EK, Jeng YJ. Adequate sleep among adolescents is positively associated with health status and health-related behaviors. BMC Public HealthLink provided by the sponsor.
- Genova HM, Rajagopalan V, Deluca J, et al. Examination of cognitive fatigue in multiple sclerosis using functional magnetic resonance imaging and diffusion tensor imaging. PLoS ONE.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes
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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.
Noha M Abo-Elfetoh, PHD study chair
Assiut University
Questions about this trial
What is this clinical trial studying?
A study testing a-tDCS in people with Multiple Sclerosis, run by Assiut 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 5 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 29 Sep 2022. 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?
Contact Entsar karem, resident (0201030698902, entsarkarem07@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
fatigue assessment scale (time frame: at post sessions, 1 month and 2 month post sessions). The study lists 2 primary outcomes in all. 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 29 Sep 2022.