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

NCT07381907 | Recruiting

• 2 other identifiers: UEPA-PD-SMA-001CAAE: 86894625.0.0000.8767
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Parkinson Disease (PD); Gait Disorders; Postural Balance

Keywords

transcranial direct current stimulation; nordic walking; parkinson disease; gait; postural balance; motor cortex; rehabilitation

Outcome Measures

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.

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

Secondary Outcomes (8)

• Timed Up and Go (seconds)

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

• Berg Balance Scale (0-56)

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

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

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

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

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

• PDQ-39 Summary Index

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

Study Arms (2)

Active tDCS over SMA + standardized Nordic Walking

EXPERIMENTAL

Participants receive anodal tDCS over the supplementary motor area (SMA) delivered concurrently with a standardized 30-minute Nordic Walking (NW) session, 3×/week for 4 weeks (12 sessions). tDCS: 2.0 mA, 20 min, saline-soaked sponge electrodes (5×7 cm), anode over midline SMA (FCz), cathode supraorbital contralateral; 30-s ramp-in/out. NW protocol identical across both arms (warm-up, technique practice with poles, continuous walking at moderate effort, cool-down).

Device: Transcranial Direct Current Stimulation (tDCS), active; Behavioral: Standardized Nordic Walking program

Sham tDCS + standardized Nordic Walking

SHAM COMPARATOR

Participants undergo the same NW protocol (30 min) on the same schedule (3×/week for 4 weeks; 12 sessions) while receiving sham tDCS with brief ramp-in/out to mimic sensations and no sustained current; electrodes and device indicators match the active condition.

Device: Sham transcranial Direct Current Stimulation; Behavioral: Standardized Nordic Walking program

Interventions

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).

Active tDCS over SMA + standardized Nordic Walking

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.

Sham tDCS + standardized Nordic Walking

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.

Active tDCS over SMA + standardized Nordic Walking; Sham tDCS + standardized Nordic Walking

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• Able to ambulate at least 10 meters with or without a cane/poles (no hands-on assistance from a therapist)
• Able to follow simple commands; provides written informed consent (MMSE ≥24 or equivalent cognitive screening)
• Willing to maintain stable PD medication and usual care during the 4-week intervention, unless medically required

You may not qualify if:

• 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
• Cognitive impairment incompatible with consent or testing (e.g., MMSE \<24)
• Current participation in other interventional trials targeting gait/balance or brain stimulation; recent initiation or dose change of antiparkinsonian medication within 4 weeks.

Sponsors & Collaborators

• Universidade Metodista de Piracicaba: lead

Study Sites (1)

UEAFTO - Unidade de Fisioterapia e Terapia Ocupacional

Belém, Pará, 66087-670, Brazil

RECRUITING

MeSH Terms

Conditions

Parkinson Disease; Mobility Limitation

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants, treating therapists and outcome assesors are blinded. The stimulator is pre-programmed under coded modes so that active and sham display identical indicators; sham includes brief ramp-in/out to mimic sensations then no sustained current. Session procedures and Nordic Walking are identical across arms to preserve blinding.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Parallel assignment with two arms (1:1): (i) active anodal tDCS over the supplementary motor area delivered concurrently with standardized Nordic Walking, and (ii) sham tDCS with the same Nordic Walking protocol. Randomization uses computer-generated permuted blocks; allocation is concealed with sequentially numbered, opaque, sealed envelopes prepared by an independent researcher. Participants receive 12 sessions over 4 weeks (3×/week).

Study Record Dates

• First Submitted: January 19, 2026
• First Posted: February 2, 2026
• Study Start: June 9, 2025
• Primary Completion: February 1, 2026
• Study Completion: March 1, 2026
• Last Updated: February 2, 2026

Record last verified: 2026-01

Locations

BR (1)