Multiple SclerosisNCT04391023
Cerebellar tDCS and Balance Training in PwMS
A study testing Balance Training, 2 mA Transcranial Direct Current Stimulation and 4 mA Transcranial Direct Current Stimulation in people with Multiple Sclerosis, run by University of Iowa at 1 site in United States.
Trial summary
Many people with multiple sclerosis (PwMS) have decreased balance and postural control, gait deficits, and a high frequency of falls. High fall rates and mobility impairments pose a significant risk to the independence and quality of life of PwMS. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Balance Training, 2 mA Transcranial Direct Current Stimulation and 4 mA Transcranial Direct Current Stimulation
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Sep 2022to 16 Jul 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- medically diagnosed with relapsing-remitting multiple sclerosis
- 18-70 years of age
- moderate disability (score of 2-6 on the Patient Determined Disease Scale)
- self-reported differences in function between legs, have fallen within the last year
- able to walk for 6 mins, and not taking any psychoactive medication.
Who cannot join
- relapse within the last 60 days
- have changed disease modifying medications in the last 45 days
- are currently pregnant
- have a concurrent neurological or neuromuscular disease
- have been hospitalized within the last 90 days
- have any contraindications for the tDCS device (i.e., pacemakers or metal implants)
- are unable to understand/sign the consent form.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of 2 mA and 4 mA Cerebellar Transcranial Direct Current Stimulation and Balance Training to Reduce Fall Risk in People With Multiple Sclerosis
Many people with multiple sclerosis (PwMS) have decreased balance and postural control, gait deficits, and a high frequency of falls. High fall rates and mobility impairments pose a significant risk to the independence and quality of life of PwMS. Therefore, effective interventions to improve balance and postural control are urgently needed to decrease the frequency of falls in PwMS. Balance training has been demonstrated to significantly improve postural control and gait in PwMS. One possible treatment modality to amplify the effects of balance training is transcranial direct current stimulation (tDCS), a non-invasive means to increase cortical excitability and potentially prime the brain for task specific learning. The cerebellum plays a vital role in balance and posture and may be an important target structure for tDCS studies seeking to reduce fall risk. Studies have shown that anodal cerebellar tDCS is effective in improving balance control in older adults with high fall risk and patients with chronic stroke. However, the most effective tDCS intensity and the duration of the effects on balance control has not been established. Moreover, no study has combined cerebellar tDCS and balance training to reduce fall risk in PwMS. The purpose of this study is to investigate the effects of cerebellar transcranial direct current stimulation (tDCS) on fall risk in people with relapsing-remitting multiple sclerosis. We will conduct tDCS or SHAM followed by balance training on 4 consecutive days. We will evaluate fall risk with well-established functional tasks, such as the Berg Balance Scale, Timed Up and Go (TUG), the six minute walk test (6MWT), and static posturography.
Prospective participants, men and women with relapsing-remitting MS, will be recruited. To accomplish this study, 30 participants will be randomly assigned into 3 groups (2 mA tDCS, 4 mA tDCS, or SHAM). This study involves 4 daily visits at the Integrative Neurophysiology Lab at the same time of day for each subject and three follow-up visits. The duration of visit 1 will be approximately 2.5 hours and the duration of visits 2-4 will be approximately 1.5 hours. Visit 5, 6, and 7 will be approximately 24 hours, 1 week, and 3 weeks, respectively, after visit 4 and will last approximately 1.5 hours. During tDCS sessions, participants will undergo either Sham, 2 mA, and 4 mA tDCS for 20 minutes followed by balance training.
- Conditions
- Multiple Sclerosis
- Being tested
- Sham Transcranial Direct Current Stimulation (tDCS), Balance Training, 2 mA Transcranial Direct Current Stimulation, 4 mA Transcranial Direct Current Stimulation
- Keywords
- Brain Stimulation, Balance Training
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sham Transcranial Direct Current Stimulation (tDCS)Device
Also called tDCS
tDCS is a non-invasive brain stimulation technique in which a very weak electrical current (2 mA) is applied to the scalp at the beginning of the session and then remains at 0 mA for the duration of the session to control for placebo-like effects. The anode and cathode will both be placed over the cerebellum.
Balance TrainingBehavioural
The balance training protocol will include balance training exercises on both compliant (i.e., foam pad and trampoline) and firm surfaces.
2 mA Transcranial Direct Current StimulationDevice
Also called tDCS
tDCS is a non-invasive brain stimulation technique in which very weak electrical current (2 mA) is applied to the scalp for 20 minutes. The anode and cathode will both be placed over the cerebellum.
4 mA Transcranial Direct Current StimulationDevice
Also called tDCS
tDCS is a non-invasive brain stimulation technique in which very weak electrical current (4 mA) is applied to the scalp for 20 minutes. The anode and cathode will both be placed over the cerebellum.
| Study group | Role | What they receive |
|---|---|---|
| Sham tDCS | Sham comparator | The tDCS device will perform a 30 second ramp up to 2 mA and then an immediate 30 second ramp down to 0 mA. Until the 19:30 minute time point, the tDCS will remain at 0 mA. At this time point, the tDCS will ramp up to 2 mA and then will immediately ramp back down to 0 mA. Receives: Device: Sham Transcranial Direct Current Stimulation (tDCS); Behavioral: Balance Training |
| 2 mA tDCS | Experimental | The participants in this group will receive tDCS at 2 mA while seated comfortably. The intensity will start at 0 mA and will be incrementally increased to the target intensity (2 mA) over the initial 30 seconds. Then, the tDCS will deliver stimulation at the target intensity until the 19:30 minute time point. At this point, the current will gradually decrease back to 0 mA. Receives: Behavioral: Balance Training; Device: 2 mA Transcranial Direct Current Stimulation |
| 4 mA tDCS | Experimental | The participants in this group will receive tDCS at 4 mA while seated comfortably. The intensity will start at 0 mA and will be incrementally increased to the target intensity (4 mA) over the initial 30 seconds. Then, the tDCS will deliver stimulation at the target intensity until the 19:30 minute time point. At this point, the current will gradually decrease back to 0 mA. Receives: Behavioral: Balance Training; Device: 4 mA Transcranial Direct Current Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Score on the Berg Balance Scale
The BBS is a valid and reliable assessment of balance during static (e.g., standing with eyes closed) and dynamic conditions (e.g., completing a 360-degree turn) conditions. BBS scores range from 0 to 56. Lower scores indicate increased impairment in balance. A cut-off score of 44 has been established as a criterion to identify PwMS with a high fall risk.
Measured: 24 hours, 2 weeks, and 4 weeks post-intervention
Time to Complete the Timed Up and Go Test (TUG)
The TUG measures the time it takes for the participant to rise from a chair, walk 3 meters, turn around, walk back to the chair, and sit down. Two trials were completed and the reported score is the average time between the two trials. A higher number means it took the participant more time to complete the task (i.e., worse performance).
Measured: 24 hours, 2 weeks, and 4 weeks post-intervention
Secondary outcomes (2)
Time to Complete the Six Minute Walk Test (6MWT)
Subjects performed the 6MWT in a cordoned-off hallway with two symbols on the ground, placed 30 meters apart. Subjects were instructed to walk as far as possible between the marks for 6 minutes, walking around each symbol like a cone. Higher scores indicate more distance walked (i.e., better performance).
Measured: 24 hours, 2 weeks, and 4 weeks post-intervention
Score on the Fatigue Severity Scale (FSS)
The FSS consists of nine statements used to assess perceived fatigability. Subjects are asked to rate how much they felt a statement applied to them, on a 7-point scale (low value = does not apply, high value = high agreement with the statement). The questionnaire is scored by calculating the average response to the statements. Therefore, the scores will range from 1 to 7 (1 = low fatigue, 7 = high fatigue). A score ≥ 4 indicates a clinically significant level of fatigue.
Measured: 24 hours, 2-weeks, and 4-weeks post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2020
- Study start26 Sep 2022
- Primary completion16 Jul 2023
- Study completion16 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by University of IowaThe 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
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Iowa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alexandra Fietsmam, University of Iowa
- Investigators
- Alexandra Fietsam, M.S., Principal investigator, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04391023
- Sponsor's protocol ID
- 201912430
- Status last verified
- May 2024
- First submitted
- 12 May 2020
- Last updated
- 18 Jun 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of 2 mA and 4 mA Cerebellar Transcranial Direct Current Stimulation and Balance Training to Reduce Fall Risk in People With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT04391023
- Acronym / sponsor ID
- 201912430
- Conditions
- Multiple Sclerosis
- Keywords
- Brain Stimulation, Balance Training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University of IowaUniversity, hospital or other
- Study start
- 26 Sep 2022 (actual)
- Primary completion
- 16 Jul 2023 (actual)
- Study completion
- 16 Jul 2023 (actual)
- First posted
- 18 May 2020 (actual)
- Results
- Posted 18 Jun 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Many people with multiple sclerosis (PwMS) have decreased balance and postural control, gait deficits, and a high frequency of falls. High fall rates and mobility impairments pose a significant risk to the independence and quality of life of PwMS. Therefore, effective interventions to improve balance and postural control are urgently needed to decrease the frequency of falls in PwMS. Balance training has been demonstrated to significantly improve postural control and gait in PwMS. One possible treatment modality to amplify the effects of balance training is transcranial direct current stimulation (tDCS), a non-invasive means to increase cortical excitability and potentially prime the brain for task specific learning. The cerebellum plays a vital role in balance and posture and may be an important target structure for tDCS studies seeking to reduce fall risk. Studies have shown that anodal cerebellar tDCS is effective in improving balance control in older adults with high fall risk and patients with chronic stroke. However, the most effective tDCS intensity and the duration of the effects on balance control has not been established. Moreover, no study has combined cerebellar tDCS and balance training to reduce fall risk in PwMS. The purpose of this study is to investigate the effects of cerebellar transcranial direct current stimulation (tDCS) on fall risk in people with relapsing-remitting multiple sclerosis. We will conduct tDCS or SHAM followed by balance training on 4 consecutive days. We will evaluate fall risk with well-established functional tasks, such as the Berg Balance Scale, Timed Up and Go (TUG), the six minute walk test (6MWT), and static posturography.
Prospective participants, men and women with relapsing-remitting MS, will be recruited. To accomplish this study, 30 participants will be randomly assigned into 3 groups (2 mA tDCS, 4 mA tDCS, or SHAM). This study involves 4 daily visits at the Integrative Neurophysiology Lab at the same time of day for each subject and three follow-up visits. The duration of visit 1 will be approximately 2.5 hours and the duration of visits 2-4 will be approximately 1.5 hours. Visit 5, 6, and 7 will be approximately 24 hours, 1 week, and 3 weeks, respectively, after visit 4 and will last approximately 1.5 hours. During tDCS sessions, participants will undergo either Sham, 2 mA, and 4 mA tDCS for 20 minutes followed by balance training.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Sham tDCS | Sham comparator | Device: Sham Transcranial Direct Current Stimulation (tDCS), Behavioral: Balance TrainingThe tDCS device will perform a 30 second ramp up to 2 mA and then an immediate 30 second ramp down to 0 mA. Until the 19:30 minute time point, the tDCS will remain at 0 mA. At this time point, the tDCS will ramp up to 2 mA and then will immediately ramp back down to 0 mA. |
| 2 mA tDCS | Experimental | Behavioral: Balance Training, Device: 2 mA Transcranial Direct Current StimulationThe participants in this group will receive tDCS at 2 mA while seated comfortably. The intensity will start at 0 mA and will be incrementally increased to the target intensity (2 mA) over the initial 30 seconds. Then, the tDCS will deliver stimulation at the target intensity until the 19:30 minute time point. At this point, the current will gradually decrease back to 0 mA. |
| 4 mA tDCS | Experimental | Behavioral: Balance Training, Device: 4 mA Transcranial Direct Current StimulationThe participants in this group will receive tDCS at 4 mA while seated comfortably. The intensity will start at 0 mA and will be incrementally increased to the target intensity (4 mA) over the initial 30 seconds. Then, the tDCS will deliver stimulation at the target intensity until the 19:30 minute time point. At this point, the current will gradually decrease back to 0 mA. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- medically diagnosed with relapsing-remitting multiple sclerosis
- 18-70 years of age
- moderate disability (score of 2-6 on the Patient Determined Disease Scale)
- self-reported differences in function between legs, have fallen within the last year
- able to walk for 6 mins, and not taking any psychoactive medication.
Key exclusion criteria (7 listed)
- relapse within the last 60 days
- have changed disease modifying medications in the last 45 days
- are currently pregnant
- have a concurrent neurological or neuromuscular disease
- have been hospitalized within the last 90 days
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 |
|---|---|---|
| Sham Transcranial Direct Current Stimulation (tDCS)Also: tDCStDCS is a non-invasive brain stimulation technique in which a very weak electrical current (2 mA) is applied to the scalp at the beginning of the session and then remains at 0 mA for the duration of the session to control for placebo-like effects. The anode and cathode will both be placed over the cerebellum. | Device | Sham tDCS |
| Balance TrainingThe balance training protocol will include balance training exercises on both compliant (i.e., foam pad and trampoline) and firm surfaces. | Behavioural | 2 mA tDCS, 4 mA tDCS, Sham tDCS |
| 2 mA Transcranial Direct Current StimulationAlso: tDCStDCS is a non-invasive brain stimulation technique in which very weak electrical current (2 mA) is applied to the scalp for 20 minutes. The anode and cathode will both be placed over the cerebellum. | Device | 2 mA tDCS |
| 4 mA Transcranial Direct Current StimulationAlso: tDCStDCS is a non-invasive brain stimulation technique in which very weak electrical current (4 mA) is applied to the scalp for 20 minutes. The anode and cathode will both be placed over the cerebellum. | Device | 4 mA tDCS |
Primary outcome
Score on the Berg Balance Scale
Time frame: 24 hours, 2 weeks, and 4 weeks post-intervention
The BBS is a valid and reliable assessment of balance during static (e.g., standing with eyes closed) and dynamic conditions (e.g., completing a 360-degree turn) conditions. BBS scores range from 0 to 56. Lower scores indicate increased impairment in balance. A cut-off score of 44 has been established as a criterion to identify PwMS with a high fall risk.
Time to Complete the Timed Up and Go Test (TUG)
Time frame: 24 hours, 2 weeks, and 4 weeks post-intervention
The TUG measures the time it takes for the participant to rise from a chair, walk 3 meters, turn around, walk back to the chair, and sit down. Two trials were completed and the reported score is the average time between the two trials. A higher number means it took the participant more time to complete the task (i.e., worse performance).
2 secondary outcomes
Time to Complete the Six Minute Walk Test (6MWT)
Time frame: 24 hours, 2 weeks, and 4 weeks post-intervention
Score on the Fatigue Severity Scale (FSS)
Time frame: 24 hours, 2-weeks, and 4-weeks post-intervention
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Alexandra Fietsam, M.S. principal investigator
University of Iowa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Balance Training, 2 mA Transcranial Direct Current Stimulation and 4 mA Transcranial Direct Current Stimulation in people with Multiple Sclerosis, run by University of Iowa at 1 site in United States.
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 5 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: finished, as of the sponsor's last update on 18 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Yes. Results are posted in the registry (first posted 18 Jun 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Score on the Berg Balance Scale (time frame: 24 hours, 2 weeks, and 4 weeks post-intervention). 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 18 Jun 2024.