Effects of Dual-transcranial Direct Current Stimulation During Physical Therapy in Sub-acute Stroke

NCT ID: NCT04051671

Last Updated: 2020-01-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-08-06
• Study Completion Date: 2019-11-06

Brief Summary

The aim of the present study is to evaluate the possible effect of using dual-tDCS applied during conventional physical therapy on lower limb function in stroke patients.

Detailed Description

Recently dual-tDCS applied before the conventional physical therapy show positive effect of lower limb performance. However to explore the time during which dual-tDCS can be combined with physical therapy to maximize motor performance is required. Results from the present study with be compared with our previous study that used dual-tDCS applied before physical therapy.

Conditions

Stroke

Study Design

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

Study Groups

Active tDCS & PT

Dual transcranial direct current stimulation (tDCS) will be applied over the leg motor area (M1) during the first 20 mins of conventional physical therapy (about 1 hours). Anodal on affected hemisphere, Cathodal on unaffected hemisphere. Current intensity is fixed at 2 mA and current will flow continuously during 20. Physical therapist will give an intervention program exactly the same in all cases. The scope of intervention is administered to improve strength of weakened and postural lower limbs muscles such as trunk muscles, hip flexors/extensors/abductors, knee flexors/extensors.

Group Type: EXPERIMENTAL

Transcranial direct current stimulation

Intervention Type: DEVICE

Dual Active/sham tDCS will be applied over the leg motor area (M1) during the first 20 mins of conventional physical therapy. Anodal on affected hemisphere, Cathodal on unaffected hemisphere. Each participant will complete two experiments (active/sham tDCS). The interval between two experiments is at least 2 weeks. The two experiments will be performed in random order for each subject.

Sham tDCS & PT

Dual transcranial direct current stimulation (tDCS) will be applied over the leg motor area (M1) during the first 20 mins (sham mode) of conventional physical therapy (about 1 hours). Anodal on affected hemisphere, Cathodal on unaffected hemisphere. Physical therapist will give an intervention program exactly the same in all cases. The scope of intervention is administered to improve strength of weakened and postural lower limbs muscles such as trunk muscles, hip flexors/extensors/abductors, knee flexors/extensors.

Group Type: ACTIVE_COMPARATOR

Transcranial direct current stimulation

Intervention Type: DEVICE

Dual Active/sham tDCS will be applied over the leg motor area (M1) during the first 20 mins of conventional physical therapy. Anodal on affected hemisphere, Cathodal on unaffected hemisphere. Each participant will complete two experiments (active/sham tDCS). The interval between two experiments is at least 2 weeks. The two experiments will be performed in random order for each subject.

Interventions

Transcranial direct current stimulation

Dual Active/sham tDCS will be applied over the leg motor area (M1) during the first 20 mins of conventional physical therapy. Anodal on affected hemisphere, Cathodal on unaffected hemisphere. Each participant will complete two experiments (active/sham tDCS). The interval between two experiments is at least 2 weeks. The two experiments will be performed in random order for each subject.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Age range 18-75 years.

2. First ever-ischemic lesion in the territory of middle cerebral artery or anterior cerebral artery. CT scan/MRI result is thus required.

3. Sub acute phase of stroke (less than 6 months)

4. Able to sit-to-stand and stand-to-sit independently

5. Able to walk without physical assistance at least 6 m

6. Free of any neurological antecedent, unstable medical conditions or condition that may increase the risk of stimulation such as epilepsy

Exclusion Criteria

1. Pre-stroke disability

2. Pregnant

3. Be unable to understand the instruction

4. No clear neurological antecedent history or psychiatric disorder

5. Excessive pain in any joint of the paretic limb (numerical pain rating score > 7)

6. Presence of intracranial metal implantation, cochlea implant, or cardiac pacemaker

7. Subjects are participating in the other protocol or receiving alternative treatment such as acupuncture

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

Sponsors

National Research Council of Thailand

OTHER_GOV

Sponsor Role: collaborator

Mahidol University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Faculty ofPhysical Therapy, Mahidol University

Salaya, Nakonpathom, Thailand

Countries

Thailand

References

Klomjai W, Aneksan B. A randomized sham-controlled trial on the effects of dual-tDCS "during" physical therapy on lower limb performance in sub-acute stroke and a comparison to the previous study using a "before" stimulation protocol. BMC Sports Sci Med Rehabil. 2022 Apr 15;14(1):68. doi: 10.1186/s13102-022-00463-9.

Reference Type: DERIVED

PMID: 35428346 (View on PubMed)

Other Identifiers

MU-CIRB 2019/045.1102

Identifier Type: -

Identifier Source: org_study_id