Group Therapy With Transcranial Direct Current Stimulation in Patients With Parkinson's Disease

NCT04174573 | Unknown

• 1 other identifier: U1111-1240-0949
• Study Type: interventional
• Target: 64
• Locations: 0 countries
• Sites: N/A

Brief Summary

To determine the effectiveness of group therapy along with transcranial direct current (tDCS) stimulation on motor symptoms, balance and quality of life in patients with Parkinson's disease(PD). 128 patient with PD will be recruited by the cluster sampling method for the two group pretest-posttest randomized controlled trial. The patient with PD will be allocated in two groups, Group therapy only (GTO) group and Group therapy with tDCS (GT-tDCS) treatment group by block randomization technique. Both GTO group and GT-tDCS group will receive the structured group therapy programme for one hour duration, twice a week for 6-weeks. In addition to the structured group therapy programme, GT-tDCS group will receive 20 minutes of tDCS application once a week for the 6-week duration. Data will be analysed at baseline, 3 weeks and 6 weeks of post intervention.

Conditions

Parkinson Disease

Keywords

tDCS; Quality of Life; Parkinson Disease; Neuronal Plasticity

Outcome Measures

Primary Outcomes (2)

• Movement Disorders Society Sponsored Unified Parkinson's Disease Rating Scale (MDS-UPDRS).

  The Unified Parkinson Disease Rating Scale, designed to monitor the burden and extent of Parkinson's disease. o-4 score, lower the score indicates normal, higher the scores indicate greater impact of PD symptoms.

  Change will be measured at baseline, 3 weeks and after 6 weeks of intervention

• Parkinson's Disease Questionnaire with 39 items

  The PDQ-39 is a 39-item self-report questionnaire, which assesses Parkinson's disease-specific health related quality over the last month. Assesses how often patients experience difficulties across the 8 quality of life dimensions. Assesses impact of Parkinson's Disease (PD) on specific dimensions of functioning and well-being. Each dimension total score ranges from 0 (never have difficulty) to 100 (always have difficulty). lower score reflect better quality of life.

  Change will be measured at baseline, 3 weeks and after 6 weeks of intervention

Study Arms (2)

Group therapy only (GTO)

EXPERIMENTAL

Patients in GTO group will receive structured group therapy programme

Other: GTO

Group therapy with tDCS (GT-tDCS)

EXPERIMENTAL

Patients in this group will receive group therapy along-with tDCS intervention

Other: GT-tDCS

Interventions

GTO OTHER

1. Forward direction activity: Balance activity in forward direction on wooden balance board (5 reps X 3 sets X 2 days in a week, for 6 weeks) 2. Backward direction activity: Balance activity in backward direction on wooden balance board (5 reps X 3 sets X 2 days in a week, for 6 weeks) 3. Sideways direction activity: Balance activity in sideways direction on wooden balance board (5 reps X 3 sets X 2 days in a week, for 6 weeks)

Group therapy only (GTO)

GT-tDCS OTHER

1. Group therapy 1. Forward direction activity: Balance activity in forward direction on wooden balance board (5 reps X 3 sets X 2 days in a week, for 6 weeks) 2. Backward direction activity: Balance activity in backward direction on wooden balance board (5 reps X 3 sets X 2 days in a week, for 6 weeks) 3. Sideways direction activity: Balance activity in sideways direction on wooden balance board (5 reps X 3 sets X 2 days in a week, for 6 weeks) 2. tDCS Left anodal and right cathodal tDCS : Anode- F3, Cathode- Right Supra orbital area, Intensity- 2mA, Duration- 30 minutes, once in a week for 6 weeks

Group therapy with tDCS (GT-tDCS)

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Presence of mild neurocognitive disorders was based on the validated Montreal Cognitive Assessment (MoCA) cutoff scores (\<23.5)
• Based on the Hoehn-Yahr Stage (HYS) staging, severity of PD was categorized as mild (HYS 1\&2), moderate (HYS 3) and severe (HYS 4\&5). Patient with PD with mild and moderate will be recruited

You may not qualify if:

• Patient with PD with associated comorbidities such as stroke, uncontrolled diabetes, sensory impairments such as hearing, vision, etc.
• Patient with PD who is not willing to participate in the study

Sponsors & Collaborators

• Maharishi Markendeswar University (Deemed to be University): lead

Related Publications (5)

• King LA, Wilhelm J, Chen Y, Blehm R, Nutt J, Chen Z, Serdar A, Horak FB. Effects of Group, Individual, and Home Exercise in Persons With Parkinson Disease: A Randomized Clinical Trial. J Neurol Phys Ther. 2015 Oct;39(4):204-12. doi: 10.1097/NPT.0000000000000101.

  PMID: 26308937 RESULT

• Lattari E, Costa SS, Campos C, de Oliveira AJ, Machado S, Maranhao Neto GA. Can transcranial direct current stimulation on the dorsolateral prefrontal cortex improves balance and functional mobility in Parkinson's disease? Neurosci Lett. 2017 Jan 1;636:165-169. doi: 10.1016/j.neulet.2016.11.019. Epub 2016 Nov 9.

  PMID: 27838447 RESULT

• Renner CIe, Outermans J, Ludwig R, Brendel C, Kwakkel G, Hummelsheim H. Group therapy task training versus individual task training during inpatient stroke rehabilitation: a randomised controlled trial. Clin Rehabil. 2016 Jul;30(7):637-48. doi: 10.1177/0269215515600206. Epub 2015 Aug 27.

  PMID: 26316552 RESULT

• Elsner B, Kugler J, Pohl M, Mehrholz J. Transcranial direct current stimulation (tDCS) for idiopathic Parkinson's disease. Cochrane Database Syst Rev. 2016 Jul 18;7(7):CD010916. doi: 10.1002/14651858.CD010916.pub2.

  PMID: 27425786 RESULT

• Nero H, Franzen E, Stahle A, Benka Wallen M, Hagstromer M. Long-Term Effects of Balance Training on Habitual Physical Activity in Older Adults with Parkinson's Disease. Parkinsons Dis. 2019 Aug 7;2019:8769141. doi: 10.1155/2019/8769141. eCollection 2019.

  PMID: 31485305 RESULT

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Adarsh K Srivastav, MPT

  Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Asir J Samuel, MPT, (Ph.D)

CONTACT

8059930222; asirjohnsamuel@mmumullana.org

Adarsh K Srivastav, MPT

CONTACT

8618889003; adarsh.srivastav@mmumullana.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: November 20, 2019
• First Posted: November 22, 2019
• Study Start: June 6, 2022
• Primary Completion: January 31, 2023
• Study Completion: October 1, 2023
• Last Updated: October 1, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share