Transcranial Stimulation for Upper Limb Training of Individuals With Sequelae From Intracranial Hemorrhage

NCT ID: NCT01992991

Last Updated: 2014-02-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-12-31

Study Completion Date

2014-04-30

Brief Summary

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The purpose of this study is to investigate the effect of transcranial stimulation for upper limb training of patients with sequelae from an intracranial hemorrhage.

Patients receive five days of upper limb occupational therapy training in combination with real or sham stimulation. Patients complete the Jebsen Taylor Hand Function Test before, after and 7 days later. The intervention takes place at patients' home address.

Detailed Description

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Aim: To investigate the effect of anodal transcranial direct current stimulation (tDCS) for upper limb training of individuals with sequelae from intracranial hemorrhage.

Design: Triple-blinded randomised controlled trial Study population: Patients with intracranial hemorrhage (ICH) of non-traumatic aetiology. Between 6 months and five years from injury.

Intervention:

Group 1 receive five days of upper limb occupational therapy in combination with anodal stimulation Group 2 receive five days of upper limb occupational therapy in combination with sham stimulation The intervention takes place at patients' home address. Assessment tool: Patients complete the Jebsen Taylor Hand Function Test at baseline, post-intervention and at 7 days follow-up.

Conditions

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Cerebrovascular Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Transcranial direct current stimulation

Anodal stimulation

Group Type EXPERIMENTAL

Transcranial direct current stimulation

Intervention Type DEVICE

Transcranial direct current stimulation of motor cortex

Sham stimulation

30 sek of Transcranial direct current stimulation

Group Type SHAM_COMPARATOR

Transcranial direct current stimulation

Intervention Type DEVICE

Transcranial direct current stimulation of motor cortex

Interventions

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Transcranial direct current stimulation

Transcranial direct current stimulation of motor cortex

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Intracranial hemorrhage
* Injury between 6 months and 5 years

Exclusion Criteria

* Traumatic brain injury
* Other neurological disorders
* Epilepsy
* Metal implants in the head
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Aarhus

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Henning Andersen, MD, PhD

Role: STUDY_DIRECTOR

Hammel Neurorehabilitation and Research Centre

Locations

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Hammel Neurorehabilitation and Research Centre

Hammel, Jutland, Denmark

Site Status

Countries

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Denmark

Other Identifiers

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tDCS-RHN

Identifier Type: -

Identifier Source: org_study_id

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