Effects of Transcranial Direct Current Stimulation Combined With Nordic Walking on Gait and Balance in Parkinson's Disease

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50-75
SponsorUniversidade Metodista de Piracicaba

About this trial

Parkinson's disease can cause slow or unsteady walking and balance problems that raise the risk of falls. This study will test whether adding a gentle, non-invasive brain stimulation called transcranial direct current stimulation (tDCS) during a supervised Nordic Walking program improves mobility in people with Parkinson's disease. Participants will be randomly assigned to receive either active tDCS or an inactive (sham) procedure that feels the same but does not deliver current, while both groups complete the same supervised walking program. Sessions occur three times per week for four weeks. We will measure walking speed with a 10-Meter Walk Test as the main outcome, and also evaluate balance, motor symptoms, quality of life, and any side effects. We expect that tDCS given during the walking sessions will help people walk faster and feel steadier compared with the walking program alone.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Idiopathic Parkinson's disease (e.g., UK Brain Bank criteria)

Hoehn & Yahr stage II-IV (on medication)

Stable antiparkinsonian medication for ≥4 weeks before enrollment

Slowed gait phenotype (e.g., ≥6 seconds on 10-Meter Walk at preferred speed)

Disqualifiers

Contraindications to tDCS: implanted cranial/brain devices (e.g., DBS), metal in the skull (excluding dental), active skin disease/lesions at electrode sites, uncontrolled epilepsy or history of seizure in the past 12 months

Unstable medical or psychiatric conditions that preclude safe participation (e.g., uncontrolled hypertension, recent cardiovascular events, severe orthostatic hypotension with syncope)

Severe freezing of gait or fall risk that prevents safe participation in supervised Nordic Walking, as judged by the clinical team

Severe musculoskeletal or vestibular disorders that limit walking with poles; severe uncorrected visual impairment

Trial design

Design model

Parallel

Treatments tested in this trial

  • Transcranial Direct Current Stimulation (tDCS), active

    Device

    Anodal tDCS over SMA (FCz) with saline-soaked sponge electrodes (5×7 cm); cathode supraorbital contralateral; 2.0 mA for 20 minutes, 30-s ramp-in/out; delivered during NW; 12 sessions over 4 weeks (3×/week).

  • Sham transcranial Direct Current Stimulation

    Device

    Same montage and timing as active; brief ramp-in/out then 0 mA for the remainder; delivered during NW; 12 sessions over 4 weeks.

  • Standardized Nordic Walking program

    Behavioral

    30-minute supervised session (5-min warm-up; 20-min continuous walking with poles at moderate perceived exertion; 5-min cool-down); technique cues for pole use and cadence; performed each visit in both arms; 12 sessions over 4 weeks.

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Active tDCS over SMA + standardized Nordic WalkingExperimental treatment 2 interventions
Group B: Sham tDCS + standardized Nordic WalkingSham comparator 2 interventions

Trial outcomes

Primary outcomes

1

Gait speed (m/s) on the 10-Meter Walk Test (10MWT)

Preferred-pace 10MWT on a straight walkway with flying start; speed computed as distance/time (central 10 m if applicable), averaged across ≥2 trials. Higher values indicate better performance. The primary endpoint is the post-intervention assessment; maintenance is examined at 1 month. Minimally important change will be reported for clinical relevance.

Time frame
Baseline; Post-intervention (4 weeks); 1-month follow-up

Secondary outcomes

1

Timed Up and Go (seconds)

Time to stand up from a chair, walk 3 m, turn, return, and sit. Lower values indicate better performance.

Time frame
Baseline; Post-intervention; 1-month follow-up
2

Berg Balance Scale (0-56)

14-item balance assessment scored 0-4 each; total 0-56. Higher scores indicate better balance.

Time frame
Baseline; Post-intervention; 1-month follow-up
3

Freezing of Gait Questionnaire (FOG-Q; 0-24)

Patient-reported freezing severity/frequency. Higher scores indicate worse freezing.

Time frame
Baseline; Post-intervention; 1-month follow-up
4

MDS-UPDRS Part III - Motor Examination (0-132)

Clinician-rated motor signs of PD. Higher scores indicate greater impairment.

Time frame
Baseline; Post-intervention; 1-month follow-up

Other outcomes

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