Safety of Transcranial Direct Current Stimulation in Pediatric Hemiparesis

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-07-31

Study Completion Date

2013-12-31

Brief Summary

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The primary objective of this proposal is to investigate the safety of use of transcranial Direct Current Stimulation (tDCS)in children with hemiparesis.

The research question, "Is transcranial Direct Current Stimulation safe for use in children with congenital hemiparesis?" relates to two hypotheses:

1. tDCS will not produce a major adverse event, including seizure activity.
2. No change in paretic or nonparetic hand function or cognitive status will occur.

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Detailed Description

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Completing a pilot safety study is paramount to the future goal of incorporating the tDCS pediatric safety data and combining tDCS and rehabilitation with constraint-induced movement therapy in order to improve motor outcomes beyond what rehabilitation therapies alone can provide and enhance quality of life for these children with hemiparesis.

Conditions

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Hemiparesis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Transcranial Direct Current Stimulation

Receiving active tDCS

Group Type EXPERIMENTAL

tDCS

Intervention Type DEVICE

transcranial direct current stimulation- non-invasive brain stimulation

Sham tDCS

tDCS equipment set to placebo setting.

Group Type SHAM_COMPARATOR

tDCS

Intervention Type DEVICE

transcranial direct current stimulation- non-invasive brain stimulation

Interventions

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tDCS

transcranial direct current stimulation- non-invasive brain stimulation

Intervention Type DEVICE

Other Intervention Names

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transcranial direct current stimulation

Eligibility Criteria

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Inclusion Criteria

1. Congenital Hemiparesis confirmed by most recent MRI or CT radiologic report.
2. Hemispheric Stroke or Periventricular Leukomalacia
3. Ages 8-17 years old
4. ≥ 10 degrees of active motion at the metacarpophalangeal joint
5. Adequate receptive language function to follow two-step commands as evidenced by performance on TOKEN test of intelligence
6. No evidence of seizure activity within the last 2 years.
7. Subject is able to give informed assent and providing a signature, along with the informed consent signature of the legal guardian as evidenced by signature.

Exclusion Criteria

1. Metabolic Disorders
2. Neoplasm
3. Epilepsy
4. Disorders of Cellular Migration and Proliferation
5. Acquired Traumatic Brain Injury
6. Expressive Aphasia
7. Pregnancy
8. Indwelling metal or incompatible medical devices
9. Evidence of skin disease or skin abnormalities
10. Botulinum toxin or phenol intramuscular block within the one-month preceding tDCS

Minimum Eligible Age

8 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No