Efficacy of transcranial magnetic stimulation in Parkinsons Disease

Active, not recruiting

Brief Summary: This is a randomized investigation to understand the role of repetetive Transcranial Magnetic stimulation patients with Parkinsons Disease. Various cortical areas are implicated in the pathophysiology of parkinsons disease namely primary motor area, Premotor area, supplementary motor area. In this study we modulated these areas with Transcranial Magnetic Stimulation and assessed the outcomes with fMRI, Clinical and motor scales.

This is a single blinded sham controlled investigation. The outcomes were assessed at baseline, 4 weeks, 8 weeks.

Recruitment & Eligibility

Inclusion Criteria

1.Diagnosis of clinically definite PD, defined by UKPD brain bank clinical and diagnostic criteria.
With presence of at least 1 out of 3 cardinal motor features of PD (resting tremor, rigidity, and postural impairment like bradykinesia); 2.PD patients of both gender with H&Y stage from 1 to 3.
3.PD patients between age 45 to 85 on stable medication for at least 30 days.

Exclusion Criteria

Subjects with any other neurological, psychiatric co-morbidities were excluded from the study.
Hypertensives and diabetics were included only if they were stable on antihypertensives and oral hypoglycaemics for past 6 months from the time of enrollment.
Also subjects with any ferromagnetic implants or dental fillings were excluded so were the subjects who were eligible for deep brain stimulation (DBS) and were scheduled to undergo surgery in next 6 months.

Primary Outcome Measures

Name	Time	Method
i.To compare the status of cortical plasticity between all the three treatment groups (M1, PM, SMA) using fMRI and FDG-PET.	Baseline 0 day \| Post Sham at 4th week \| Post Real at 8th week \| [Baseline:-After recruitment \| Post-Sham:-After 4 sessions of Sham TMS \| Post-Real:- After 4 sessions of Real TMS.]
ii.To compare the clinical condition of the patients in the three treatment groups on the basis of UPDRS, H & Y scale, PDQ-39, HAM-A, HAM-D, HADS and CGI.	Baseline 0 day \| Post Sham at 4th week \| Post Real at 8th week \| [Baseline:-After recruitment \| Post-Sham:-After 4 sessions of Sham TMS \| Post-Real:- After 4 sessions of Real TMS.]
iii.To compare the motor performance of the patient using Purdue peg-board test, and Timed motor tests.	Baseline 0 day \| Post Sham at 4th week \| Post Real at 8th week \| [Baseline:-After recruitment \| Post-Sham:-After 4 sessions of Sham TMS \| Post-Real:- After 4 sessions of Real TMS.]

Secondary Outcome Measures

Name	Time	Method
1.To compare the clinical condition of the patients in the three treatment groups on the basis of UPDRS, H & Y scale, PDQ-39, HAM-A, HAM-D, and CGI.	2.To compare the motor performance of the patient using Purdue peg-board test, and Timed motor tests.

Locations (1): All India Institute Of Medical Sciences, New DELHI
🇮🇳
South, DELHI, India
All India Institute Of Medical Sciences, New DELHI
🇮🇳South, DELHI, India
CO Prof Vinay Goyal
Principal investigator
drvinaygoyal@gmail.com