Lesioning Procedures for Movement Disorders

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorAll India Institute of Medical Sciences

About this trial

Dystonia is a rare syndrome with varying etiologies. Similarly, tremor conditions refractory to medical management and disabling that they need surgical interventions are rare in our setting. So far there are no randomized controlled trials of pallidotomy for management of dystonia. There is scant literature on the long term efficacy and safety of Pallidotomy, thalamotomy and other such lesioning procedures in the management of movement disorders. The current literature is significantly plagued by publication bias as case reports with successful outcomes are likely to be selectively published in journals or conference abstracts. Lesioning procedures though seem to be effective are often considered to be risky, especially bilateral pallidotomy is not preferred by several centres. However, our center routinely performs simultaneous bilateral pallidotomy. To generate long term data on the efficacy and safety of lesioning procedures in rare diseases like dystonias especially the effect of functional neurosurgery on varying etiologies of the disease, robust registries are required which collect data on all consecutive patients who undergo the procedure.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients with movement disorders admitted at the Neurology wards/attending clinics

Who are being considered for lesioning procedures

Of all ages and sexes

Disqualifiers

None

Trial population

Patients with movement disorders such as Dystonia, Tremors or Parkinson's Disease who are being considered to undergo pallidal, subthalamic or thalamic lesioning procedures.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Pallidal, subthalamic or thalamic lesioning

    Procedure/Surgery

    Radiofrequency, ultrasound guided or other lesioning procedures of the Globus pallidus interna, subthalamic nucleus or Vim nucleus of the thalamus for the management of Movement disorders

Treatment groups

250 Participants
are divided into 2 treatment groups
Group A: Lesioning group1 intervention
Group B: Control group0 interventions

Trial outcomes

Primary outcomes

1

Long term functional outcomes

Long term outcomes in patients undergoing lesioning procedures for the treatment of Dystonia - Burke Fahn Marsden Dystonia - Disability scale. Lesser score is better

Time frame
1 year
2

Long term functional outcomes

Long term outcomes in patients undergoing lesioning procedures for the treatment of Parkinson Disease - Unified Parkinson Disease Rating Scale (UPDRS). Lesser score is better

Time frame
1 year

Secondary outcomes

1

Predictors of outcomes

To study the factors determining outcomes in patients undergoing lesioning procedures for movement disorders

Time frame
1 year
2

Demography

To study the demographic features (age, gender, age of onset, age at which lesioning is done) of patients undergoing lesioning procedures for the treatment of Movement disorders

Time frame
Baseline at enrolment
3

Clinical features

To study the clinical features in patients undergoing lesioning procedures for the treatment of Movement disorders

Time frame
Baseline at enrolment
4

Laboratory findings

To study the laboratory findings, genetic study results in patients undergoing lesioning procedures for the treatment of Movement disorders

Time frame
Baseline at enrolment

Other outcomes

Sponsors and contacts

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