Combined Functional Electrical and Transcranial Direct Current Stimulation for Foot Drop (tDCS)

Saint Joseph's University, Philadelphia

Status: Enrolling

Conditions: Falls; Post Stroke Recovery; Foot Drop

Treatments: Behavioral: Standard protocol for combo of FES and tDCS

Study type: Interventional

Funder types: Other

Identifiers

NCT07592221

StJosephsU

Details and patient eligibility

About

This study aims to determine if combining the treatments of transcranial direct current stimulation (tDCS) and functional electrical stimulation (FES) will better help persons with stroke who have difficulty lifting their toes. As part of the treatment, subjects will receive electrical stimulation through pads on their scalp (similar to what one may have received in physical therapy previously to an arm or leg). This protocol is called transcranial direct current stimulation (tDCS). Subjects will also receive electrical stimulation through pads on their leg. This is called functional electrical stimulation (FES). During treatment sessions, subjects will also perform leg activity/strengthening exercises. The aim is to evaluate whether combining FES and tDCS within a PT session would reduce foot drop as indicated by improvements in the amount of toe clearance and ankle motion persons with stroke.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria: To participate, you must be:

• 18 years or older
• Have had 1 or more strokes (> 6 months) affecting ankle dorsiflexion.
• Discharged from all rehabilitative services.
• Can walk independently with/without using an assistive device such as a cane without an ankle-foot orthosis (AFO) for 15 minutes.

Exclusion Criteria: You must not have:

• An inability to repeat and understand 2-step commands.
• Peripheral neuropathy
• Damage to the skull or scalp, such as a fracture History of seizures or epilepsy Extremely high or low blood pressure or heart rate Chest pain or shortness of breath when you are resting Botox injections to your leg or foot in the last 4 months

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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30 participants in 2 patient groups

FES and tDCS

Experimental group

Description:

The tDCS was applied as a bilateral montage with the anode of the tDCS device (ActivaDose II, ActivaTek Inc., Salt Lake City, Utah, USA) applied to the involved hemisphere and the cathode over the unaffected hemisphere. The dosage of the tDCS device was one mA for 60 minutes for the duration of the gait training delivered via a pair of sponge electrodes moistened with 0.9% NaCl solution. The exact locations for the electrode placements were based on a 20-point electrode system, in which we chose two points that targeted the motor cortex region corresponding to the left lower limb. Treatments were performed twice weekly over the 8 weeks. The FES was administered to the tibialis anterior muscle of the impaired lower extremity with one electrode over the common peroneal nerve at the head of the fibula and the other over a motor point in the middle of the muscle belly of the tibialis anterior muscle.

Treatment:

Behavioral: Standard protocol for combo of FES and tDCS

FES with tDCS subthreshold

Active Comparator group

Description:

The tDCS was applied as a bilateral montage with the anode of the tDCS device (ActivaDose II, ActivaTek Inc., Salt Lake City, UT, USA) applied to the involved hemisphere and the cathode over the unaffected hemisphere. The dosage of the tDCS device was set initially at one mA for 60 minutes and then for the duration of the gait training the machine was turned to subthreshold levels, delivered via a pair of sponge electrodes moistened with 0.9% NaCl solution. The exact locations for the electrode placements were based on a 20-point electrode system, in which we chose two points that targeted the motor cortex region corresponding to the left lower limb. Treatments were performed twice weekly over the 8 weeks. The FES was administered to the tibialis anterior muscle of the impaired lower extremity with one electrode over the common peroneal nerve at the head of the fibula and the other over a motor point in the middle of the muscle belly of the tibialis anterior muscle.

Treatment:

Behavioral: Standard protocol for combo of FES and tDCS