tDCS and Physical Therapy in Stroke

NCT ID: NCT00542256

Last Updated: 2017-03-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 85 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-09-30
• Study Completion Date: 2014-11-10

Brief Summary

The purpose of this study is to determine whether a painless and noninvasive procedure called transcranial direct current stimulation (tDCS) combined with a method of physical therapy called constraint-induced movement therapy improves motor function in patients with chronic stroke. Research in healthy subjects has shown that when tDCS is combined with motor learning tasks, there is an increase in learning as compared to motor learning tasks only. The tDCS procedure sessions will be compared to sham (fake) procedure sessions, which is also called placebo stimulation. This study is double blind, which means neither the subjects nor researchers analyzing motor function will know if participants are receiving real tDCS stimulation or placebo. Only the person performing the procedure will know which one participants are receiving. Only by comparing the tDCS procedure to a sham (placebo) procedure can we understand if the tDCS actually improves motor function.

We hypothesize that tDCS will enhance the effects of constraint-induced movement therapy on motor recovery in chronic stroke patients.

Conditions

Cerebrovascular Accident

Study Design

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

Study Groups

1

Each subject will receive 14 days (2 week period: 10 weekdays and 2 weekends) of constraint induced movement therapy. In addition, on the 10 weekdays during the treatment period, the subjects will come into the laboratory and receive up to 6 hours per day of training of the affected arm in a variety of tasks. At the beginning of each of the 10 weekday training sessions, participants will receive 40 minutes of active tDCS over the primary motor cortex.

Group Type: ACTIVE_COMPARATOR

Active transcranial Direct Current Stimulation / Constraint Induced Movement Therapy

Intervention Type: DEVICE

14 days of constraint induced movement therapy with 10 weekdays of up to 6 hours of training of the affected arm combined with application of tDCS over the primary motor cortex for 40 minutes.

2

Each subject will receive 14 days (2 week period: 10 weekdays and 2 weekends) of constraint induced movement therapy. In addition, on the 10 weekdays during the treatment period, the subjects will come into the laboratory and receive up to 6 hours per day of training of the affected arm in a variety of tasks. At the beginning of each training day tDCS will be applied for 40 minutes with the current active for only 30 seconds over the primary motor cortex.

Group Type: SHAM_COMPARATOR

Sham transcranial Direct Current Stimulation / Constraint Induced Movement Therapy

Intervention Type: DEVICE

14 days of constraint induced movement therapy with 10 days of up to 6 hours of training in the affected arm and sham tDCS applied over the primary motor cortex for 40 minutes with active current applied for 30 seconds.

Interventions

Active transcranial Direct Current Stimulation / Constraint Induced Movement Therapy

14 days of constraint induced movement therapy with 10 weekdays of up to 6 hours of training of the affected arm combined with application of tDCS over the primary motor cortex for 40 minutes.

Intervention Type: DEVICE

Sham transcranial Direct Current Stimulation / Constraint Induced Movement Therapy

14 days of constraint induced movement therapy with 10 days of up to 6 hours of training in the affected arm and sham tDCS applied over the primary motor cortex for 40 minutes with active current applied for 30 seconds.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• First time clinical ischemic or hemorrhagic cerebrovascular accident (radiologically confirmed)
• Demonstrates adequate balance while wearing a hand restraint on the unaffected arm
• Ability to stand from a sitting position and ability to stand with or without upper extremity support
• Stroke onset at least 6 months prior to study enrollment

Exclusion Criteria

• Significant pre-stroke disability
• Any substantial decrease in alertness, language reception, or attention that might interfere with understanding instructions for motor testing
• Excessive pain in any joint of the paretic extremity
• A terminal medical diagnosis consistent with survival of less than 1 year
• Advanced liver, kidney, cardiac, or pulmonary disease
• Coexistent major neurological or psychiatric disease (including epilepsy)
• A history of significant alcohol or drug abuse in the prior 3 years
• Use of neuropsychotropic drugs - such as antidepressants
• Patients may not be actively enrolled in a separate intervention study targeting stroke recovery
• Patients may not have already received constraint-induced movement therapy and/or tDCS treatment for stroke

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beth Israel Deaconess Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Felipe Fregni

Study Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Felipe Fregni, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Beth Israel Deaconess Medical Center

Locations

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Countries

United States

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)

Related Links

http://www.tmslab.org

Related Info

Other Identifiers

2007P000420

Identifier Type: -

Identifier Source: org_study_id