Effect of Transcranial Direct Current Stimulation on Peripheral Neuropathy
Effect of Transcranial Direct Current Stimulation on Proprioceptive and Vibratory Sensation: Potential Benefit for Patients With Peripheral Neuropathy
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
This study will be performed in patients with peripheral neuropathy who are walking independently, but have complains of balance problems such as recent falls or difficulty walking and show reduced vibratory and proprioceptive sensation during routine neurologic examination. These patients will be tested for proprioceptive and vibratory threshold at the toes and ankles before, during and after receiving anodal transcranial direct current stimulation (tDCS) over sensory and motor cortices. Subjects will be asked to participate in 2 sessions. In one of the sessions, decided randomly, the stimulation will be applied on the right side and in the second session it will be on the left.
The tDCS portion of the experiment will begins with direct current (maximum of 2 mA) stimulation delivered through surface electrodes (TransQE from IOMED®, surface area: 25 cm2) using a Phoresor® II Auto (Model No. PM850, IOMED®, Salt Lake City, Utah 84120, USA). One electrode will be positioned above the left or right primary motor cortex, the other electrode over the forehead.
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
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Maryland
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Baltimore, Maryland, Förenta staterna, 21287
- Johns Hopkins Hospital
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- Peripheral Neuropathy
- Walking independently but with problems with balance
Exclusion Criteria:
- Prominent weakness at the ankle
- Not able to walk independently
- History of Seizure
- Cardiac Pacemaker
- Metal implants in the head
- Increased intracranial pressure
- Pregnancy
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Stödjande vård
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
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Experimentell: dTCS
Patient will receive dTCS with direct current (maximum of 2 mA) stimulation delivered through surface electrodes (TransQE from IOMED®, surface area: 25 cm2) using a Phoresor® II Auto (Model No. PM850, IOMED®, Salt Lake City, Utah 84120, USA) or Sham stimulation.
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Direct current (DC) (maximum of 2 mA) stimulation delivered through surface electrodes.
One electrode will be positioned above the left or right primary motor cortex, the other electrode over the forehead.
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Sham Comparator: Sham
Patients will receive a sham.
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The device will administer a sham.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
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Change in Vibratory Threshold as Measured by Rydel Seiffer Graduated Tuning Fork at the Toes
Tidsram: At 10 and 20 minutes
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Vibration is measured by reading in Rydel Seiffer tuning fork that ranges between 0-8 and is a standard tool fro measuring vibration sensation at the toes.
A reading of 0 means absent vibration.
A reading of more than 4 at the toes are considered normal.
Change between assessment at 20 minutes and 10 minutes at the toes will be assessed.
A recording of less than 4 indicates an abnormal results and a lower number means worse neuropathy.
For example, reading of 0 means absent vibration feeling which indicates worse neuropathy than a reading of 2.
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At 10 and 20 minutes
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Change in Minimum Detectable Angle (Degree) of Dorsiflexion of the Toe
Tidsram: At 10 and 20 minutes
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At 10 and 20 minutes
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Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Mohammad Khoshnoodi, MD, Johns Hopkins University
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- IRB00066426
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
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