tDCS and Robotic Therapy in Stroke

NCT ID: NCT01828398

Last Updated: 2014-01-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-11-30
• Study Completion Date: 2013-11-30

Brief Summary

After stroke a limited motor recovery in the paretic upper limb accounts for a large proportion of the disabling sequelae. Only about 15% of those with initial complete upper limb paralysis after stroke recover functional use of their impaired arm in daily life.

The aim of this study is to test the effects of tDCS combined with upper extremity robot-assisted therapy on stroke survivors.

Conditions

Stroke; Upper Extremity Impairments

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

sham-tDCS + UE robot-assisted therapy

This group will receive the same robot-assisted therapy of the intervention group, in association of sham-tDCS. This consists in a 30 seconds stimulation, with the same instrumentation and electrodes placement. This method of sham stimulation was previously validated.

Group Type: SHAM_COMPARATOR

sham-tDCS + UE robot-assisted therapy

Intervention Type: DEVICE

real-tDCS + UE robot-assisted therapy

This group will receive continuous stimulation lasting 30 minutes during the session of robot-assisted therapy. The training session, which includes multiplanar, repetitive and target reaching movements, will be given 5 times a week for 2 weeks(REO Therapy System; Motorika, Medical LTD, Israel). Each session will last about 30 minutes.

Transcranial direct current stimulation (tDCS) will be administered as follows. The anode will be placed on the primary motor cortex (M1) of the affected hemisphere and the cathode on the contralateral M1 area. The direct current is transmitted through a pair of sponge electrodes, with a surface of 35 cm2 (7x5), soaked in saline solution and, it is generated by a constant current stimulator, with rechargeable batteries (Brainstim, EMS, Italy). This continuous stimulation lasted 30 minutes, with an intensity of 1mA.

Group Type: EXPERIMENTAL

real-tDCS + UE robot-assisted therapy

Intervention Type: DEVICE

Interventions

real-tDCS + UE robot-assisted therapy

Intervention Type: DEVICE

sham-tDCS + UE robot-assisted therapy

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Males and females subjects. Age > 18 years.
• Diagnosis of first ischemic stroke
• Impairment of the upper limb
• Trunk control defined in the Trunk-Control Test (TCT), with a score > 50.

Exclusion Criteria

• anyone who does not have adequate understanding of verbal or written information in Italian sufficient to complete any test
• Impaired cognitive functioning: score less than 24 on the Mini Mental Status Examination (MMSE)
• contraindications to single-pulse transcranial magnetic stimulation (TMS)(TMS will be used to measure cortical excitability): presence of a history of epilepsy, frequent headaches or neck pain, implantable devices (ventriculoperitoneal shunts, pacemakers, intrathecal pumps, intracranial metal implants)
• Contraindications to tDCS: intracranial metal implants that can be stimulated, incorrectly positioned or over-heated by the electric current
• Neurological or psychiatric pathology
• severe cardio-pulmonary, renal, hepatic diseases
• Pregnancy

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital of Ferrara

OTHER

Sponsor Role: lead

Responsible Party

Sofia Straudi, MD

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Ferrara University Hospital

Ferrara, , Italy

Countries

Italy

References

Elsner B, Kugler J, Pohl M, Mehrholz J. Transcranial direct current stimulation (tDCS) for improving activities of daily living, and physical and cognitive functioning, in people after stroke. Cochrane Database Syst Rev. 2020 Nov 11;11(11):CD009645. doi: 10.1002/14651858.CD009645.pub4.

Reference Type: DERIVED

PMID: 33175411 (View on PubMed)

Other Identifiers

Stroke_tDCS

Identifier Type: -

Identifier Source: org_study_id