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Transcranial Stimulation for Upper Limb Training of Individuals With Sequelae From Intracranial Hemorrhage (tDCS-ICH)

Primary Purpose

Cerebrovascular Disorders

Status
Unknown status
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Transcranial direct current stimulation
Sponsored by
University of Aarhus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebrovascular Disorders focused on measuring transcranial stimulation, Intracranial hemorrhage, Home training, Occupational Therapy, Jebsen Taylor Hand Function Test

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hammel Neurorehabilitation and Research Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Transcranial direct current stimulation

Sham stimulation

Arm Description

Anodal stimulation

30 sek of Transcranial direct current stimulation

Outcomes

Primary Outcome Measures

Change in Jebsen Taylor Hand Function Test
Involves seven items regarding activities of daily living

Secondary Outcome Measures

Full Information

First Posted
November 11, 2013
Last Updated
February 17, 2014
Sponsor
University of Aarhus
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1. Study Identification

Unique Protocol Identification Number
NCT01992991
Brief Title
Transcranial Stimulation for Upper Limb Training of Individuals With Sequelae From Intracranial Hemorrhage
Acronym
tDCS-ICH
Official Title
Transcranial Direct Current Stimulation for Upper Limb Training of Individuals With Sequelae From Intracranial Hemorrhage
Study Type
Interventional

2. Study Status

Record Verification Date
February 2014
Overall Recruitment Status
Unknown status
Study Start Date
December 2013 (undefined)
Primary Completion Date
April 2014 (Anticipated)
Study Completion Date
April 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Aarhus

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebrovascular Disorders
Keywords
transcranial stimulation, Intracranial hemorrhage, Home training, Occupational Therapy, Jebsen Taylor Hand Function Test

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Transcranial direct current stimulation
Arm Type
Experimental
Arm Description
Anodal stimulation
Arm Title
Sham stimulation
Arm Type
Sham Comparator
Arm Description
30 sek of Transcranial direct current stimulation
Intervention Type
Device
Intervention Name(s)
Transcranial direct current stimulation
Intervention Description
Transcranial direct current stimulation of motor cortex
Primary Outcome Measure Information:
Title
Change in Jebsen Taylor Hand Function Test
Description
Involves seven items regarding activities of daily living
Time Frame
Change from baseline until 7 days follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Henning Andersen, MD, PhD
Organizational Affiliation
Hammel Neurorehabilitation and Research Centre
Official's Role
Study Director
Facility Information:
Facility Name
Hammel Neurorehabilitation and Research Centre
City
Hammel
State/Province
Jutland
ZIP/Postal Code
8450
Country
Denmark

12. IPD Sharing Statement

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

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