Diabetic PolyneuropathyNCT04516200
Effect of Transcranial Direct Current Stimulation on Sensory Integration
A study testing transcranial direct current stimulation and traditional physical therapy program and designed physical therapy program in people with Diabetic Polyneuropathy, run by MTI University.
Trial summary
To determine the effect of Transcranial direct current stimulation on sensory integration and risk of falling in diabetic polyneuropathy. Read more about this study
- Who is it for?
- Ages 50 to 65 years, women only
- Conditions the study is for
- Diabetic Polyneuropathy
- What is being tested?
- transcranial direct current stimulation and traditional physical therapy program and designed physical therapy program
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Aug 2020to Oct 2020
- 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 50 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1 - Patient will be diagnosed as having Diabetic Polyneuropathy (DPN) and all patients have type II diabetes.
- 2-The age of the patients ranged from 35 to 55 years.
- 3-Clinically all patients suffered from glove stock hyposthesia, numbness and burning sensation and mild distal moror weakness
- 4-Patients have sensorymotor peripheral neuropathy according to neurophysiological study to detect sensory and motor conduction velocity to confirm diagnosis.
Who cannot join
- History of diabetic ulcer and amputation .
- Osteoporosis.
- Fractures of lower limbs.
- Gross musculoskeletal problems eg:burn.
- Significant Scar tissue or calluses on the feet.
- Peripheral vascular diseases (PVD) or Microcirculation problems.
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- Balance disturbance rather than diabetic peripheral neuropathy as ear problems, labrynthinitis, stroke or cerebellar problems.
- Visual disturbance.
- Autonomic neuropathy.
- Advanced Osteoarthritis of lower limbs.
- Nerve root compression (Radicuolopathy) affecting lower limbs.
- Patients with implanted devices for pain control such as deep brain
About this study
Official title: Effect of Transcranial Direct Current Stimulation on Sensory Integration and Risk of Falling in Diabetic Polyneuropathy
To determine the effect of Transcranial direct current stimulation on sensory integration and risk of falling in diabetic polyneuropathy.
Read the detailed description
PURPOSE:
To determine the effect of Transcranial direct current stimulation on sensory integration and risk of falling in diabetic polyneuropathy.
BACKGROUND:
Diabetic polyneuropathy is the most prevalent chronic complication affecting 30% - 50% of diabetic patients. Diabetic polyneuropathy usually affect the peripheral, autonomic, and central nervous systems with several clinical symptoms .About 80% of the cases of DN manifest as distal symmetrical sensorimotor polyneuropathy which is responsible for cases of chronic pain; impaired sleep quality; increase of the falling risk associated with weakness and increase of the risk of extremities amputation. Transcranial direct current stimulation is neurophysiologic intervention that alters cortical excitability to enhance lower extremity somato-sensation and thus improve functional outcomes.
HYPOTHESES:
There will be no effect of Transcranial direct current stimulation on sensory integration and risk of falling in diabetic polyneuropathy
- Conditions
- Diabetic Polyneuropathy
- Being tested
- transcranial direct current stimulation and traditional physical therapy program, designed physical therapy program
- Medical subject headings
- Diabetic Neuropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcranial direct current stimulation and traditional physical therapy programDevice
Also called Gymna- uniphy(phy-action 787)
Transcranial stimulation will be applied only for the study group.
designed physical therapy programOther
sensory training and balance training
| Study group | Role | What they receive |
|---|---|---|
| Transcranial direct current stimulation | Experimental | Transcranial direct current stimulation will be applied to study group only . Anodal transcranial stimulation will be applied on left somatosensory cortex while the cathodal one will be applied on right supra-orbital area with frequency of 2m.A for 20 minutes.Stimulation will be applied three times per week for two months. Receives: Device: transcranial direct current stimulation and traditional physical therapy program; Other: designed physical therapy program |
| traditional physical therapy program | Placebo comparator | traditional physical therapy program will be applied to both the control group and study group. It will be consist of sensory re-education training and balance training.Exercises will be applied three times per week for two months Receives: Other: designed physical therapy program |
What is being measured
The primary outcome is the main question the study is designed to answer.
sway index of sensory integration test
sway index of sensory integration test will be measured by biodex balance system
Measured: two months
Secondary outcomes (1)
risk of fall index
risk of fall index will be measured by biodex balance system
Measured: two months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2020
- Study startAug 2020 (estimated)
- Primary completionAug 2020 (estimated)
- Study completionOct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic PolyneuropathyStudies 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
- Model description
- Group 1: transcranial direct current stimulation and traditional physical therapy program Group 2: the same traditional physical therapy program
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MTI University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara Salah El-Din Abdel Megeed, MTI University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04516200
- Sponsor's protocol ID
- P.T.REC/012/002000
- Status last verified
- Aug 2020
- First submitted
- 13 Aug 2020
- Last updated
- 20 Aug 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Transcranial Direct Current Stimulation on Sensory Integration and Risk of Falling in Diabetic Polyneuropathy
- ClinicalTrials.gov ID
- NCT04516200
- Acronym / sponsor ID
- P.T.REC/012/002000
- Conditions
- Diabetic Polyneuropathy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- MTI UniversityUniversity, hospital or other
- Study start
- Aug 2020 (estimated)
- Primary completion
- Aug 2020 (estimated)
- Study completion
- Oct 2020 (estimated)
- First posted
- 18 Aug 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.
To determine the effect of Transcranial direct current stimulation on sensory integration and risk of falling in diabetic polyneuropathy.
Detailed description
PURPOSE:
To determine the effect of Transcranial direct current stimulation on sensory integration and risk of falling in diabetic polyneuropathy.
BACKGROUND:
Diabetic polyneuropathy is the most prevalent chronic complication affecting 30% - 50% of diabetic patients. Diabetic polyneuropathy usually affect the peripheral, autonomic, and central nervous systems with several clinical symptoms .About 80% of the cases of DN manifest as distal symmetrical sensorimotor polyneuropathy which is responsible for cases of chronic pain; impaired sleep quality; increase of the falling risk associated with weakness and increase of the risk of extremities amputation. Transcranial direct current stimulation is neurophysiologic intervention that alters cortical excitability to enhance lower extremity somato-sensation and thus improve functional outcomes.
HYPOTHESES:
There will be no effect of Transcranial direct current stimulation on sensory integration and risk of falling in diabetic polyneuropathy
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Group 1: transcranial direct current stimulation and traditional physical therapy program Group 2: the same traditional physical therapy program
| Arm | Type | Receives |
|---|---|---|
| Transcranial direct current stimulation | Experimental | Device: transcranial direct current stimulation and traditional physical therapy program, Other: designed physical therapy programTranscranial direct current stimulation will be applied to study group only . Anodal transcranial stimulation will be applied on left somatosensory cortex while the cathodal one will be applied on right supra-orbital area with frequency of 2m.A for 20 minutes.Stimulation will be applied three times per week for two months. |
| traditional physical therapy program | Placebo comparator | Other: designed physical therapy programtraditional physical therapy program will be applied to both the control group and study group. It will be consist of sensory re-education training and balance training.Exercises will be applied three times per week for two months |
Who may qualify
- Ages
- 50 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 1 - Patient will be diagnosed as having Diabetic Polyneuropathy (DPN) and all patients have type II diabetes.
- 2-The age of the patients ranged from 35 to 55 years.
- 3-Clinically all patients suffered from glove stock hyposthesia, numbness and burning sensation and mild distal moror weakness
- 4-Patients have sensorymotor peripheral neuropathy according to neurophysiological study to detect sensory and motor conduction velocity to confirm diagnosis.
Key exclusion criteria (12 listed)
- History of diabetic ulcer and amputation .
- Osteoporosis.
- Fractures of lower limbs.
- Gross musculoskeletal problems eg:burn.
- Significant Scar tissue or calluses on the feet.
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 and traditional physical therapy programAlso: Gymna- uniphy(phy-action 787)Transcranial stimulation will be applied only for the study group. | Device | Transcranial direct current stimulation |
| designed physical therapy programsensory training and balance training | Other | Transcranial direct current stimulation, traditional physical therapy program |
Primary outcome
sway index of sensory integration test
Time frame: two months
sway index of sensory integration test will be measured by biodex balance system
1 secondary outcome
risk of fall index
Time frame: two months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2020.
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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.
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 transcranial direct current stimulation and traditional physical therapy program and designed physical therapy program in people with Diabetic Polyneuropathy, run by MTI 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 4 inclusion and 12 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 20 Aug 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?
sway index of sensory integration test (time frame: two months). 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 20 Aug 2020.