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Neuromodulation on Motor Function in Parkinson's Disease

Transcranial Direct Current Stimulation (tDCS) Associated With Gait Training in Improving Motor Function in Parkinson's Disease

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02250690
Enrollment
24
Registered
2014-09-26
Start date
2013-09-30
Completion date
2014-11-30
Last updated
2014-09-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Idiopathic Parkinsons Disease

Keywords

idiopathic PD, Hoehn and Yahr stage I to III, stable medication usage, age 40 to 80 years, absence of cognitive impairment

Brief summary

The aims of the present study was to analyze the effect of consecutive sessions of Transcranial direct current stimulation associated to kinesiotherapy about gait performance of Parkinson' s disease. For this, the primary outcome was evaluation of gait performance by means of space and temporal parameters as speed (meter/second ), stride frequency (steps/min) and stride length (m). The secondary outcome is motor cortex excitability which is analyzed by means of single pulse transcranial magnetic stimulation (TMS) intends to determine: motor evoked potential amplitude (MEP) and rest motor threshold (rMT).

Detailed description

This study consist by interventions involving screening followed by evaluation, where volunteers were subjected to the many tests: history, session III of the Unified Scale Modified Parkinson's Disease - Unified Parkinson 's Disease Rating Scale, Ten meters walk test - Walk Test 10 meters and shoot gait, (using Studio Version 8 software). On the same day, the subjects underwent assessment of brain excitability to determine motor threshold and amplitude of the motor evoked potential (MEP). The randomization of the volunteers was conducted by an external search through opaque envelopes ordered according to a random distribution. The subjects were divided into two groups : control group , this group submitted to Transcranial Stimulation sessions a sham Continuous Current (sham tDCS) and gait training , and Experimental group, subjected to the stimulation by Transcranial Direct Current sessions (active tDCS ) and gait training.

Interventions

DEVICEexperimental group - tDCS
DEVICEControl group (tDCS sham)

Sponsors

Universidade Federal de Pernambuco
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* Main eligibility criteria were idiopathic Parkinson's disease * Both sex * Hoehn and Yahr stage I to III * Showing mild to severe gait disturbances * Stable medication usage * Age 40 to 80 years * And absence of cognitive impairment and disorders interfering with participation in cueing therapy.

Exclusion criteria

* Presence of chronic disabling pathologies of lower limb * Presence of pacemaker or severe cardiovascular conditions * A history of tumor, prior neurosurgical brain * Intervention, or severe cardiovascular conditions, including the presence of a pacemaker * A diagnosis of epilepsy or major psychiatric disorders. * Participants with other neurological, muscular, or psychiatric disorders (e.g. peripheral neuropathies, uncorrected visual problems, hearing problems, vestibular dysfunction, stroke, seizure, migraine, or frequent severe headaches) were excluded. * Participants with surgical implants, significant postural tremor, dyskinesia, severe freezing or dementia were also excluded.

Design outcomes

Primary

MeasureTime frameDescription
Change on BradykinesiaThis outcome will be measure before and after each session, before ten sessions, 1 and 2 months after ten sessionThis outcome will be measure in three different moments of evaluation and at all interventions (sessions) days - before and after intervention. Beyond these evaluations, the voluntairs will be evaluate at: T1- before ten sessions; T2- Immediately after ten sessions and T3- after a period of 1 month without intervention.

Secondary

MeasureTime frameDescription
Change on Cortical excitabilityThe evaluation occur in 3 different moments: before and after each session, after a period of 1 month without intervention. This outcome will be measure at all intervention and evaluation daysThe secondary outcome measures will be done using amplitude of Motor Evoked Potential (MEP) and rest Motor Threshold (rMT) elicited by transcranial magnetic stimulation (TMS) by means of Neuro-MS device of Neurosoft.

Other

MeasureTime frameDescription
Change on BalanceThis outcome will be measure before ten sessions, 1 and 2 months after ten sessionBerg Balance scale (BBS) is measured asking to the patient for change posture in sit position for search balance during transferences and standing with one foot at single or double support, with open and closed eyes, narrow support base body, rotation around the own body axis; take up an object at floor and others. This outcome is done using a scale with scores range from 0 to 56.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026