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

Not Applicable

• Conditions: Cerebrovascular Disorders
• Interventions: Device: Transcranial direct current stimulation

• Registration Number: NCT01992991
• Lead Sponsor: University of Aarhus

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.

Study Timeline

• Study First Submitted: 2013-11-11
• Study First Submitted QC: 2013-11-18
• Study First Posted: 2013-11-25
• Study Start: 2013-12
• Status Verified: 2014-02
• Last Update Submitted: 2014-02-17
• Last Update Posted: 2014-02-19
• Primary Completion: 2014-04
• Study Completion: 2014-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

• Intracranial hemorrhage
• Injury between 6 months and 5 years

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Exclusion Criteria

• Traumatic brain injury
• Other neurological disorders
• Epilepsy
• Metal implants in the head

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Transcranial direct current stimulation	Transcranial direct current stimulation	Anodal stimulation
Sham stimulation	Transcranial direct current stimulation	30 sek of Transcranial direct current stimulation

Primary Outcome Measures

Name	Time	Method
Change in Jebsen Taylor Hand Function Test	Change from baseline until 7 days follow-up	Involves seven items regarding activities of daily living

Trial Locations

Locations (1)

Hammel Neurorehabilitation and Research Centre; 🇩🇰 Hammel, Jutland, Denmark