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

Cerebrovascular Disorders Clinical Trial

— tDCS-ICH  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01992991
• Other study ID #: tDCS-RHN
• Status: Active, not recruiting
• Phase: N/A
• First received: November 11, 2013
• Last updated: February 17, 2014
• Start date: December 2013
• Est. completion date: April 2014

Study information

• Verified date: February 2014
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 16
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cerebrovascular Disorders
• Hemorrhage
• Intracranial Hemorrhages

Intervention

Device:
• Transcranial direct current stimulation
Transcranial direct current stimulation of motor cortex

Locations

Country	Name	City	State
Denmark	Hammel Neurorehabilitation and Research Centre	Hammel	Jutland

Sponsors (1)

Lead Sponsor	Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Jebsen Taylor Hand Function Test	Involves seven items regarding activities of daily living	Change from baseline until 7 days follow-up	No