Ischemic StrokeNCT02610387
The Effects of tDCS Combined With Balance Training on Lower Limbs Spasticity in Chronic Stroke Patients
A study testing Transcranial direct current stimulation (tDCS) in people with Ischemic Stroke, run by Shahid Beheshti University of Medical Sciences at 1 site in Iran.
Trial summary
Spasticity is one of the most common disorders in patients with central nervous system diseases such as stroke. Transcranial direct current stimulation stimulation (tDCS) is a noninvasive tool that can be used to modulate cortical excitability of the leg motor area, and the spinal motor circuits as well. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemic Stroke
- What is being tested?
- Transcranial direct current stimulation (tDCS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteIran
- Study dates
- 12 Sep 2016to 20 Dec 2017
- 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
- age ≥18 years;
- first-ever ischemic stroke;
- chronic phase of recovery (>6 months);
- ability to walk 6- meter supported or unsupported;
- ability to stand at least unsupported for 40-seconds with eyes closed;
- only ischemic stroke involving middle cerebral artery (MCA) territory confirmed by CT or MRI.
Who cannot join
- Use of any neuro- or psycho-active medications that alters balance;
- any other neurological conditions or sensory disorders affecting postural control; such as brain tumor, or substance abuse; orthopedic diseases;
- ongoing/recent (within 3 months) balance rehabilitation.
Trial locations and contacts
1 site in 1 country.
Iran1 site, 1 recruiting
- Recruiting
Shahid Beheshti Univesity of Medical sciences
Tehran, Velenjak, 1616931111
Fariba Yadolahi, MD-MPH-PhD, +989109564012, fariba.yadolahi@sbmu.ac.ir
Fariba Yadolahi, MD-MPH-PhD
About this study
Official title: The Effects of tDCS Combined With Balance Training on Lower Limbs Spasticity in Chronic Stroke Patients ( A Randomized Controlled Trial)
Spasticity is one of the most common disorders in patients with central nervous system diseases such as stroke. Transcranial direct current stimulation stimulation (tDCS) is a noninvasive tool that can be used to modulate cortical excitability of the leg motor area, and the spinal motor circuits as well.
Objective:The objectives of this study is to examine the efficacy of anodal tDCS combined with Biodex balance training on lower limbs spasticity in chronic stroke patients using laboratory and clinical assessments.
Read the detailed description
In a randomized, sham-controlled, double-blinded clinical study, hemiplegic chronic stroke patients are randomized to receive active tDCS delivered to lesioned leg motor cortex (CZ) or sham combined with balance training with Biodex balance system.
Experimental group receive tDCS stimulation (2mA) for 20 min, 5 sessions in five days paired with 20 min balance training.
- Conditions
- Ischemic Stroke
- Being tested
- Transcranial direct current stimulation (tDCS), Sham tDCS
- Keywords
- tDCS, stroke, Spasticity
- Medical subject headings
- Ischemic Stroke, Stroke, Muscle Spasticity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial direct current stimulation (tDCS)Device
Participants underwent tDCS(2mA) brain stimulation for 20 minutes plus balance training for 20 minutes for 5 consecutive days.
Sham tDCSDevice
During sham stimulation, the current ramped up for 30 seconds, ramped back down for 30 seconds, and then remained off for the duration of the stimulation plus balance training for 20 minutes for 5 consecutive days.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1:tDCS | Active comparator | Transcranial direct current stimulation (tDCS) Participants underwent tDCS(2mA) brain stimulation (20 minutes) and simultaneous balance training(20 minutes) for 5 consecutive days Receives: Device: Transcranial direct current stimulation (tDCS) |
| Arm 2: Sham tDCS | Sham comparator | Sham tDCS and simultaneous balance training(20 minutes) for 5 consecutive days Receives: Device: Sham tDCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Spasticity (Modified Ashworth scale)
Modified Ashworth scale(MAS)
Measured: After 5 days
Secondary outcomes (2)
Motoneuron excitability (H-reflex latency)
H-reflex latency
Measured: After 5 days
Motoneuron excitability
H Max/M MaxRatio
Measured: After 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2015 (estimated)
- Study start12 Sep 2016
- Primary completion20 Dec 2017 (estimated)
- Study completion20 Dec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic StrokeStudies 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shahid Beheshti University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fariba Yadolahi, Shahid Beheshti University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02610387
- Sponsor's protocol ID
- tDCS and Spasticity
- Status last verified
- Jul 2017
- First submitted
- 18 Nov 2015
- Last updated
- 25 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of tDCS Combined With Balance Training on Lower Limbs Spasticity in Chronic Stroke Patients ( A Randomized Controlled Trial)
- ClinicalTrials.gov ID
- NCT02610387
- Acronym / sponsor ID
- tDCS and Spasticity
- Conditions
- Ischemic Stroke
- Keywords
- tDCS, stroke, Spasticity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Shahid Beheshti University of Medical SciencesUniversity, hospital or other
- Study start
- 12 Sep 2016
- Primary completion
- 20 Dec 2017 (estimated)
- Study completion
- 20 Dec 2017 (estimated)
- First posted
- 20 Nov 2015 (estimated)
- 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.
Spasticity is one of the most common disorders in patients with central nervous system diseases such as stroke. Transcranial direct current stimulation stimulation (tDCS) is a noninvasive tool that can be used to modulate cortical excitability of the leg motor area, and the spinal motor circuits as well.
Objective:The objectives of this study is to examine the efficacy of anodal tDCS combined with Biodex balance training on lower limbs spasticity in chronic stroke patients using laboratory and clinical assessments.
Detailed description
In a randomized, sham-controlled, double-blinded clinical study, hemiplegic chronic stroke patients are randomized to receive active tDCS delivered to lesioned leg motor cortex (CZ) or sham combined with balance training with Biodex balance system.
Experimental group receive tDCS stimulation (2mA) for 20 min, 5 sessions in five days paired with 20 min balance training.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1:tDCS | Active comparator | Device: Transcranial direct current stimulation (tDCS)Transcranial direct current stimulation (tDCS) Participants underwent tDCS(2mA) brain stimulation (20 minutes) and simultaneous balance training(20 minutes) for 5 consecutive days |
| Arm 2: Sham tDCS | Sham comparator | Device: Sham tDCSSham tDCS and simultaneous balance training(20 minutes) for 5 consecutive days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- age ≥18 years;
- first-ever ischemic stroke;
- chronic phase of recovery (>6 months);
- ability to walk 6- meter supported or unsupported;
- ability to stand at least unsupported for 40-seconds with eyes closed;
Key exclusion criteria (3 listed)
- Use of any neuro- or psycho-active medications that alters balance;
- any other neurological conditions or sensory disorders affecting postural control; such as brain tumor, or substance abuse; orthopedic diseases;
- ongoing/recent (within 3 months) balance rehabilitation.
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 |
|---|---|---|
| Transcranial direct current stimulation (tDCS)Participants underwent tDCS(2mA) brain stimulation for 20 minutes plus balance training for 20 minutes for 5 consecutive days. | Device | Arm 1:tDCS |
| Sham tDCSDuring sham stimulation, the current ramped up for 30 seconds, ramped back down for 30 seconds, and then remained off for the duration of the stimulation plus balance training for 20 minutes for 5 consecutive days. | Device | Arm 2: Sham tDCS |
Primary outcome
Spasticity (Modified Ashworth scale)
Time frame: After 5 days
Modified Ashworth scale(MAS)
2 secondary outcomes
Motoneuron excitability (H-reflex latency)
Time frame: After 5 days
Motoneuron excitability
Time frame: After 5 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2017.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial direct current stimulation (tDCS) in people with Ischemic Stroke, run by Shahid Beheshti University of Medical Sciences at 1 site in Iran.
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 6 inclusion and 3 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 25 Jul 2017. 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 Iran. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fariba Yadolahi, MD-MPH-PhD Candidate (989109564012, fariba.yadolahi@sbmu.ac.ir), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Spasticity (Modified Ashworth scale) (time frame: After 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 25 Jul 2017.